Clinical Research Jobs

Roles & Responsibilities:• Assist Principal Investigator (PI) in site feasibility assessments• Support pre-trial documentation and regulatory readiness• Collect and maintain updated CVs of site staff• Ensure timely completion of financial disclosure forms, PI undertaking, and confidentiality agreements• Coordinate with IRB/IEC for faster approvals and timely submission of safety reports and protocol amendments• Assist PI & Co-Investigators in Informed Consent Process• Prepare for Site Initiation Visits (SIV)• Maintain Site Master File (SMF) and patient files• Handle patient recruitment, screening, enrollment, and follow-ups• Complete CRF and clinical data entry• Coordinate patient follow-up visits (physical & telephonic)• Report and follow-up on SAE (Serious Adverse Events)• Manage drug accountability and inventory tracking• Maintain study budget sheets and track IRB fees, site administration fees, lab costs, and patient reimbursementsQualification:• B.Pharm, M.Pharm, Pharm.D, Msc, BSc, LifesciencesExperience:• 1–4 years in clinical research / clinical trialsSkills:• Knowledge of ICH-GCP Guidelines• Experience with IRB/IEC Submissions• SAE Reporting & Drug Safety• CRF Completion & Clinical Data Management• Patient Recruitment & Site CoordinationAbout The Company:Max Healthcare is one of India’s leading hospital networks, offering an advanced research ecosystem for clinical trials. The company is focused on providing comprehensive healthcare and pioneering clinical research that adheres to global standards, promoting patient safety and the highest standards of care.

Roles & Responsibilities:• Process and upload regulatory correspondence (letters, emails, meeting minutes) into RIM systems in alignment with eCTD structure• Ensure accurate metadata classification and identify regulatory commitments and health authority deadlines• Extract structured data from FDA Summary Basis of Approval (SBA) documents, including trial design, sample size, and dosing details• Capture clinical endpoints, statistical outcomes (P-values, Hazard Ratios, Confidence Intervals), and regulatory conclusions• Identify and document key regulatory milestones such as Breakthrough Therapy, Orphan Drug Designation, and RMAT• Review and summarize Advisory Committee meeting content, voting results, and key discussions• Maintain database consistency through cross-referencing FDA sources (e.g., Drugs@FDA) using standardized terminology• Support internal audits and health authority inspections through efficient document retrieval and data accuracy• Ensure RIM database serves as a single source of truth with 100% data integrityQualification:• Bachelor’s / Master’s degree or Pharm D in Life Sciences, Pharmacy, Clinical Research, or related disciplineExperience:• 2–4 years of experience in Regulatory Operations, Regulatory Information Management, Document Management, or Clinical ResearchSkills:• Strong understanding of drug development lifecycle and global health authorities (FDA, EMA, etc.)• Good knowledge of FDA CDER/CBER approval package structures• Ability to interpret clinical trial data (double-blind studies, ITT analysis, non-inferiority trials)• Hands-on experience with RIM tools such as Veeva Vault (preferred)• Proficiency in MS Excel, Google Sheets, and document management systems• Excellent written English with strong summarization skills• High attention to detail and ability to manage high-volume work under strict timelinesPreferred:• Certification or PG Diploma in Regulatory Affairs• Experience supporting audits and regulatory inspectionsAbout the Organization:Roche is a global healthcare leader committed to innovation, inclusion, and patient-centric solutions. Roche Services & Solutions enables Roche teams worldwide by delivering high-quality end-to-end business services with a OneRoche mindset.

Roles & Responsibilities:• Partner with Global Study Leaders to monitor study conduct, progress, risks, timelines, and budgets• Support end-to-end operational study delivery from study set-up to close-out and archival• Maintain and ensure completeness of study systems, trackers, databases, and project plans• Review key clinical documents (Protocol, ICFs) and support development of monitoring, vendor, risk, and deviation management plans• Coordinate cross-functional study team communication, meetings, and documentation• Act as primary point of contact for country oversight activities including recruitment, data completeness, deviations, and local budgets• Manage vendor and CRO oversight, ensuring delivery of study-specific deliverables• Oversee clinical supplies, investigational products, and study materials; escalate supply risks proactively• Ensure eTMF inspection readiness through setup, periodic review, and follow-up on missing or quality issues• Support financial activities including change orders, expense tracking, and budget consistency across systemsQualification:• Bachelor’s degree in Life Sciences or related disciplineExperience:• Relevant experience in clinical trial coordination, study operations, or global study delivery• Experience working in FSP, CRO, or sponsor environments preferredSkills:• Strong knowledge of clinical trial operations and study lifecycle• Experience with eTMF oversight, vendor/CRO management, and country coordination• Good understanding of ICH-GCP and regulatory requirements• Strong project management, risk management, and analytical skills• Excellent communication, coordination, and stakeholder management skills• Ability to work in a global, cross-functional environmentAbout the Organization:The organization is a global biopharmaceutical leader advancing vaccines and innovative medicines, offering FSP professionals global exposure, end-to-end study ownership, and strong career growth opportunities in clinical research.

Roles & Responsibilities:• Perform on-site and remote clinical monitoring activities as per monitoring plan• Ensure protocol compliance, ICH-GCP adherence, and regulatory requirements• Conduct SDR, SDV, and CRF reviews to ensure data accuracy• Assess investigational product accountability and site documentation• Identify site issues, perform root cause analysis, and support CAPA implementation• Ensure audit readiness and timely issue escalation to clinical management• Initiate, monitor, and close out clinical trial sites• Maintain essential documents, TMF completeness, and CTMS updates• Coordinate with investigational sites, clients, and project teams• Support investigator meetings, payments, and study progress reportingQualification:• Bachelor’s degree in Life Sciences or related field• Registered Nursing qualification may also be consideredExperience:• Minimum 2+ years of experience as an on-site Clinical Research Monitor• Valid driving license (where applicable)Skills:• Strong clinical monitoring and risk-based monitoring knowledge• Good understanding of ICH-GCP, regulatory guidelines, and medical terminology• Excellent critical thinking, problem-solving, and RCA skills• Strong communication, documentation, and interpersonal skills• Good computer skills (MS Office, CTMS, clinical systems)• Ability to work independently, manage time effectively, and adapt to changeAbout the Organization:Thermo Fisher Scientific, through its PPD clinical research services, supports global clinical trials end-to-end, helping customers deliver high-quality, cost-efficient studies that improve health outcomes worldwide.

Roles & Responsibilities:• Manage and maintain Trial Master File (TMF / eTMF) ensuring 100% audit readiness• Prepare and review Protocols, ICFs, CRFs, CSRs• Ensure compliance with ICH-GCP, FDA 21 CFR Part 11, ISO 14155• Coordinate Site Initiation, Monitoring, and Close-Out Visits• Support regulatory submissions and health authority inspections• Conduct internal audits and manage CAPA• Work with CTMS & EDC systems (Medidata RAVE, Oracle Inform, Veeva Vault)• Generate trial metrics and dashboards using Advanced ExcelQualification:• Bachelor’s degree in Life Sciences / Health Sciences / Nursing / Pharmacology• GCP Certification (Mandatory)Experience:• 4–8 years in clinical research documentation & site coordinationSkills:• Strong knowledge of TMF management, regulatory compliance, and clinical operations• Proficiency in clinical trial systems and data management• Excellent documentation, coordination, and analytical skillsAbout the Organization:Hvantage is a growing clinical research and healthcare services organization, offering hybrid work flexibility, global trial exposure, and strong career growth opportunities for experienced professionals.

Roles & Responsibilities• Provide end-to-end oversight of animal health clinical trials from study set-up to completion• Obtain comprehensive understanding of study protocols, objectives, timelines, and deliverables• Define roles and responsibilities of study personnel and ensure alignment across teams• Collaborate with sponsors to establish and manage projected study timelines• Oversee execution of study activities to ensure tasks are completed accurately and on time• Manage GCP-compliant late-phase clinical trials in animal health• Review and contribute to study protocols, amendments, and final study reports• Monitor study progress, risks, and issues, ensuring timely escalation and resolution• Work cross-functionally with internal teams and external stakeholders to support study delivery• Ensure high standards of data quality, compliance, and documentation throughout the trial lifecycleQualification• Degree in Life Sciences, Veterinary Sciences, Pharmacy, or related disciplineExperience• Minimum 8+ years of clinical trial management experience within a CRO or animal health pharmaceutical organization• Proven experience managing GCP-compliant late-phase animal health clinical trials• Hands-on experience in protocol development and final study report writingSkills• Strong clinical trial management and leadership skills• High attention to detail with strong analytical mindset• Excellent time management and multitasking ability• Strong communication and stakeholder management skills• Dependability, flexibility, and ability to work effectively in team environments• Customer-centric and solution-oriented approachAbout the CompanyArgenta is a global animal health contract research and contract development and manufacturing organization (CRO/CDMO) dedicated exclusively to improving the lives of animals. Founded in 2006, Argenta partners with animal health companies worldwide, providing end-to-end solutions from molecule to market, supported by a strong culture of teamwork, innovation, customer focus, and global collaboration.

Roles & Responsibilities• Manage and drive study start-up activities including Pre-SIV and site activation tasks• Act as primary point of contact for assigned sites during start-up and activation phases• Build and maintain strong relationships with investigators and site staff• Support feasibility, pre-qualification, and qualification activities including remote qualification visits• Prepare, negotiate, and facilitate execution of Confidentiality Agreements and amendments• Manage country and site-level Trial Master File (TMF) documentation ensuring first-time quality• Configure, collect, review, and approve essential regulatory documents for site readiness and activation• Customize, review, and negotiate country and site-specific Informed Consent Forms and translations• Prepare and submit IRB/IEC and regulatory authority applications and manage approvals• Forecast, plan, and track IRB/IEC, regulatory submissions, and site activation timelines• Update and maintain Clinical Trial Management Systems and other clinical systems accurately• Identify, resolve, or escalate site risks related to timelines, training, data quality, or compliance• Support sites with system access and ensure completion of required study training• Ensure assigned sites are audit- and inspection-ready at all times• Maintain compliance with ICH-GCP, local regulations, sponsor requirements, and Parexel SOPs• Support protocol amendments and maintenance activities through study close-out• Collaborate with cross-functional teams to meet project milestones and deliverables• Maintain timely completion of administrative tasks including timesheets, expenses, and metrics• Contribute as a subject matter expert and mentor to other team membersQualification• Bachelor’s degree in Life Sciences, Pharmacy, or other health-related discipline• Nursing qualification or equivalent clinical research experience may be consideredExperience• Substantial experience in clinical trial start-up activities• Prior experience in clinical research with strong understanding of trial methodology and terminology• Experience working with IRB/IEC, regulatory submissions, and site activation processesSkills• Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial processes• Proven problem-solving, analytical, and decision-making skills• Excellent organisational, time management, and prioritisation abilities• Strong written, verbal, and interpersonal communication skills• Proficiency in CTMS, eTMF, and MS Office applications• Ability to work independently and in matrixed, virtual teams• High attention to detail with strong quality and compliance focus• Ability to work across cultures and manage multiple stakeholders• Client-focused mindset with flexibility and adaptabilityAbout the CompanyParexel is a leading global contract research organization supporting the development of innovative therapies across a broad range of therapeutic areas. With a strong focus on patient safety, regulatory compliance, and operational excellence, Parexel partners with sponsors worldwide to accelerate clinical development and bring life-changing treatments to patients faster.

Roles & Responsibilities• Monitor clinical research regulations and guidance to identify and implement changes in operational processes• Provide expert advice to Principal Investigators, Clinical Research Coordinators, and research personnel on compliance requirements• Ensure regulatory and ethical compliance across the full lifecycle of clinical research and trials• Conduct ongoing education and training programs for clinical research staff• Perform on-site monitoring for industry-funded and investigator-initiated clinical studies• Develop, review, and maintain Standard Operating Procedures (SOPs) and training documents• Ensure adherence to Good Clinical Practice (GCP), FDA regulations, and applicable guidelines• Support compliance oversight related to grants, contracts, and institutional research practicesQualification• Bachelor’s degree in Nursing, Public Health, Healthcare, Clinical Research, or related disciplineExperience• Minimum 4+ years of professional experience in academic or regulatory clinical research settings• Experience managing or training clinical research personnel• Exposure to academic medical center research practicesSkills• Strong knowledge of GCP, FDA regulations, and clinical research compliance• Understanding of Medicare Coverage Analysis, Fair Market Value, and Standard of Care• Familiarity with medical coding, medical terminology, and electronic health information systems• Proficiency in Microsoft Office applications• Strong problem-solving and analytical skills• Ability to interpret and apply federal and non-federal regulations for grant and contract managementAbout the CompanyThe University of Toledo is a comprehensive public research university committed to advancing education, research, and healthcare innovation. Through its strong clinical research and compliance frameworks, the university supports ethical, high-quality research while fostering diversity, inclusion, and equal opportunity across its academic and research communities.

Roles & Responsibilities• Perform clinical monitoring and site management activities to ensure study conduct as per protocol, GCP, ICH, and sponsor requirements• Conduct site selection, initiation, routine monitoring, and close-out visits in line with contracted scope of work• Support and track subject recruitment plans in collaboration with study sites to meet project timelines• Deliver protocol and study-related training to assigned sites and maintain ongoing communication• Evaluate site quality, data integrity, and protocol compliance, escalating issues where required• Track regulatory submissions, ethics approvals, recruitment, enrollment, and CRF completion• Support start-up activities and ensure study milestones are achieved• Ensure essential documents are filed correctly in the Trial Master File (TMF) and Investigator Site File (ISF)• Prepare monitoring visit reports, follow-up letters, and site management documentation• Collaborate with cross-functional study team members to support project execution• Support site-level subject recruitment planning where applicable• Assist with site financial management, invoice collection, and trial agreement compliance when requiredQualification• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related disciplineExperience• Minimum 3+ years of relevant experience as a Clinical Research Associate• Experience in site monitoring, trial start-up, and close-out activities• Exposure to multicentre clinical trials preferredSkills• Strong knowledge of ICH-GCP, regulatory guidelines, and clinical trial processes• Proven site monitoring and site management skills• Ability to manage multiple studies and priorities effectively• Strong written and verbal communication skills• Good documentation, reporting, and organisational abilities• Ability to work independently and collaboratively in project teamsAbout the CompanyIQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. Operating across multiple regions in India and worldwide, IQVIA supports the development and commercialization of innovative therapies through high-quality, compliant, and data-driven clinical research solutions.

Roles & Responsibilities• Coordinate and conduct clinical studies for new products in compliance with SOPs, ICH-GCP, and applicable regulatory guidelines• Set up clinical trial sites and liaise with investigators, doctors, and consultants for smooth trial conduct• Coordinate with Ethics Committees and ensure compliance with GCP, SOPs, and regulatory requirements• Prepare and submit documentation to Institutional Review Boards for clinical study approvals• Monitor clinical trials throughout the study duration, including onsite monitoring visits• Perform source data verification and periodic data reviews for safety and compliance• Maintain Trial Master File at study sites and manage participant compensation budgets• Prepare Clinical Investigation Reports and Clinical Evaluation Reports as per applicable standards• Review and support Clinical Evaluation Reports for CE-marked medical devices• Plan and execute Post Market Surveillance activities including PMS, PMCF, and Periodic Safety Update/User ReportsQualification• Degree in Life Sciences, Pharmacy, Biomedical Engineering, or related clinical research disciplineExperience• Experience in clinical research or clinical studies preferred• Hands-on exposure to ethics committee coordination and clinical trial monitoring desirableSkills• Strong understanding of ICH-GCP, SOPs, and regulatory requirements• Clinical trial monitoring and site management skills• Source data verification and clinical documentation expertise• Good communication and coordination skills with investigators and ethics committees• Strong attention to detail and compliance-oriented mindset• Ability to work independently and as part of a multidisciplinary teamAbout the CompanyAurolab is a leading medical device manufacturing organization based in Madurai, India, known for its contribution to affordable and high-quality ophthalmic and healthcare solutions. Associated with the Aravind Eye Care ecosystem, Aurolab focuses on innovation, clinical excellence, and regulatory compliance to improve access to essential medical technologies globally.

Roles & Responsibilities• Perform and coordinate all aspects of clinical monitoring and site management activities• Conduct remote and onsite monitoring visits to ensure protocol, regulatory, and ICH-GCP compliance• Apply risk-based monitoring approaches including root cause analysis and corrective/preventive actions• Ensure data accuracy through source data review, source data verification, and CRF review• Assess investigational products through inventory checks and documentation review• Prepare monitoring reports, follow-up letters, and documentation in a timely manner• Escalate site issues and protocol deviations to clinical management and ensure resolution• Maintain regular communication with investigative sites between monitoring visits• Support site initiation, routine monitoring, and trial close-out activities• Ensure essential documents are complete and audit-ready as per regulatory requirements• Update study systems including CTMS and provide trial progress reports to Clinical Team Manager• Facilitate effective communication between sites, sponsors, and project teams• Support audits, inspections, and regulatory requests• Maintain administrative activities including timesheets and expense reports• Contribute to project deliverables, process improvements, and team initiativesQualification• Bachelor’s degree in Life Sciences or related field OR Registered Nursing qualification• Formal academic or vocational qualification relevant to clinical researchExperience• Minimum 2+ years of experience as a Clinical Research Associate or onsite clinical monitor• Experience across different monitoring models including FSO, FSP, or government studies preferred• Willingness to travel as required for monitoring activitiesSkills• Strong clinical monitoring and site management skills• Working knowledge of ICH-GCP, regulatory requirements, and SOPs• Risk-based monitoring, root cause analysis, and problem-solving ability• Strong written and verbal communication skills• Excellent organisational and time management skills• High attention to detail and data quality focus• Ability to work independently and within cross-functional teams• Proficiency in Microsoft Office and clinical trial systems• Adaptability and flexibility in dynamic clinical research environmentsAbout the CompanyThermo Fisher Scientific is a global leader in scientific services, supporting life-changing research through its PPD® clinical research portfolio. Operating across more than 100 countries, the organization delivers end-to-end clinical development services, helping sponsors bring innovative therapies to market while advancing global health outcomes through high-quality, compliant, and efficient clinical research.

Roles & Responsibilities• Conduct clinical assessments, including venepuncture, for patients participating in neurological clinical trials• Review and support care of patients with neurodegenerative conditions involved in research studies• Perform delegated duties as an Associate Investigator in accordance with Good Clinical Practice (GCP)• Apply sound clinical judgement in neurological assessments and trial-related decision-making• Work collaboratively with neurologists, research nurses, and trial coordinators• Support clinical trial activities, documentation, and protocol adherence• Prioritise tasks effectively while following organisational policies and study-specific procedures• Provide guidance on routine clinical and administrative matters within scope• Escalate complex clinical or operational issues to senior medical staff when required• Assist neurologists with patient-related administrative tasks and trial documentationQualification• Medical degree with current registration with AHPRA• Professional indemnity insuranceExperience• Experience in clinical practice required• Prior exposure to clinical trials or research environments preferred• Experience managing patients with neurodegenerative conditions desirable• Ability to commit for a minimum of 12 monthsSkills• Strong clinical judgement and independent decision-making ability• Excellent communication, interpersonal, and problem-solving skills• Ability to work effectively within multidisciplinary clinical and research teams• Understanding of Good Clinical Practice (GCP) principles• Competence with IT systems including Microsoft Office and clinical software• Ability to work with patients with cognitive or speech impairments (desirable)About the CompanyNeuroscience Research Australia is a leading medical research institute dedicated to understanding and treating neurological and neurodegenerative diseases. Based in Sydney, NeuRA works closely with clinicians, researchers, and patients to deliver high-quality clinical research and patient-centred care, supporting innovation in neuroscience and improving outcomes for individuals with complex neurological conditions.

Roles & Responsibilities• Manage volunteer registration and screening processes• Coordinate with diagnostic laboratories for clinical reports• Conduct and support the informed consent process for study volunteers• Perform volunteer enrolment activities as per study protocol• Monitor volunteers throughout the study duration• Support investigational product administration activities• Manage volunteer discharge activities as per protocol requirements• Compile, maintain, and update study documents and Trial Master File (TMF)Qualification• B.Pharm / M.PharmExperience• 2–3 years of relevant experience in clinical research or clinical pharmacology studiesNo. of Positions: 07Skills• Good understanding of clinical trial processes and GCP guidelines• Strong documentation and coordination skills• Attention to detail and ability to follow protocols• Effective communication and teamwork skillsAbout the OrganizationJeevan Scientific Technology Limited is a leading life sciences services company offering integrated solutions in clinical research, bioavailability and bioequivalence studies, regulatory, and quality services, supporting global pharmaceutical and biotech organizations.

Roles & Responsibilities• Serve as primary point of contact between Sponsor and JSTL for clinical trial projects• Develop and manage Master Service Agreements (MSA) in coordination with Sponsors• Provide guidance on MSA terms to all Functional Leads• Develop and maintain SOPs for clinical trial project management• Lead project initiation involving Sponsors, Functional Leads, CRAs, Investigators, and site staff• Supervise CRAs in site selection, contracts, budget negotiations, and regulatory submissions• Oversee site start-up, monitoring, execution, and close-out activities• Ensure compliance with national/local regulations, ICH-GCP guidelines, and JSTL SOPs• Monitor regulatory updates and ensure implementation of changes impacting clinical trials• Ensure audit and inspection readiness of sites and follow-up on audit findings• Manage project timelines, milestones, budgets, and resource allocation• Provide periodic project assessments and progress reports to Sponsors and leadership• Maintain MSAs and project metrics using Microsoft management tools• Manage internal and external resources including vendors and third-party contractors• Support hiring, training, performance management, and retention of clinical operations staffQualification• Master’s degree in Life Sciences• Advanced degree (MS Pharmacy / PharmD / PhD / MD) preferred• Certification in Clinical Trial Project Management preferredExperience• 3–5 years of experience in clinical trial project management• Experience managing Phase I–IV clinical trials preferred• Prior experience in CRO or pharmaceutical industry desirableSkills• Strong written and verbal communication skills• Excellent stakeholder and sponsor management capabilities• Strong planning, organizational, and multitasking abilities• Ability to work independently in a regulated, patient-focused environment• Strong analytical, critical thinking, and decision-making skills• Ability to manage cross-functional and diverse teams with integrity• Proficiency in Microsoft Project Manager and related IT tools for metrics and reportingAbout the OrganizationJeevan Scientific Technology Limited is a global life sciences services organization providing integrated solutions in clinical research, regulatory affairs, project management, pharmacovigilance, and medical writing, supporting pharmaceutical and biotech companies across the full clinical development lifecycle.

Roles & Responsibilities• Act as regulatory lead on assigned projects and collaborate with cross-functional teams (Clinical, Data Management, Biostatistics, Operations)• Prepare Clinical Study Reports (CSRs), clinical summaries, protocol summaries, and regulatory responses• Interpret and understand clinical trial protocols, study design, data analysis, timelines, and patient recruitment• Coordinate document review, approvals, QC, and submission activities• Arrange and lead internal and external document review meetings• Independently resolve content and scientific issues during document development• Develop scientific publications including manuscripts, abstracts, posters, and oral presentations• Provide project and timeline management support for ongoing programs• Ensure timely delivery of regulatory submissions and updates to leadership• Communicate progress, milestones, risks, and resource needs to management• Ensure compliance with ICH, CDSCO, and applicable regulatory guidelines and SOPs• Identify and implement process improvements• Mentor junior writers and oversee internal teams or external vendorsQualification• Bachelor’s degree in Life Sciences with significant writing experience• Advanced degree (MS Pharmacy / PharmD / PhD / MD) preferred• Certification in Regulatory Affairs and/or Medical Writing preferredExperience• 2–4 years of industry experience in regulatory or medical writing• Experience in healthcare, CROs, academia, or related areas such as clinical research, regulatory, quality, or R&DSkills• Strong knowledge of clinical development processes and ICH-GCP guidelines• Expertise in regulatory and clinical document writing• Working knowledge of statistical concepts and data interpretation• Excellent written and verbal communication skills• High attention to detail with strong editing and peer-review abilities• Experience with CTD templates and electronic document management systems• Proficiency in MS Word, PowerPoint, Excel, and Adobe Illustrator• Strong project management, coordination, and mentoring skillsAbout the OrganizationJeevan Scientific Technology Limited is a global life sciences services company delivering integrated solutions across clinical research, regulatory affairs, pharmacovigilance, and medical writing, supporting pharmaceutical and biotech organizations throughout the product lifecycle.

Roles & Responsibilities• Collect, review, and process Adverse Event (AE) and Serious Adverse Event (SAE) reports• Perform case processing and data entry in drug safety databases• Ensure accuracy, completeness, and timeliness of safety case documentation• Conduct literature search and review for safety-relevant information• Assist in signal detection, risk assessment, and safety evaluations• Support preparation and submission of safety reports such as PSURs and DSURs• Ensure compliance with ICH-GCP, ICH-E2B, and global regulatory guidelines• Coordinate with cross-functional teams including Clinical, Regulatory, and Quality• Maintain safety records and support audit and inspection readinessQualification• Bachelor’s degree in Pharmacy, Life Sciences, Nursing, or a related disciplineExperience• 0 to 2 years of experience in Pharmacovigilance or Drug Safety• Freshers with relevant academic knowledge may also applySkills• Basic knowledge of pharmacovigilance and drug safety concepts• Understanding of AE/SAE reporting and regulatory requirements• Good written and verbal communication skills• Strong attention to detail and analytical skills• Ability to work independently and in a team environment• Proficiency in MS Word, Excel, and safety databases is an advantageAbout the OrganizationJeevan Scientific Technology Limited is a leading life sciences and healthcare solutions company offering services across pharmacovigilance, clinical research, regulatory affairs, and data management. The organization supports global pharmaceutical and biotech companies with high-quality, compliant, and technology-driven solutions.

Roles & Responsibilities• Conduct site initiation, routine monitoring, and close-out visits as per protocol and GCP• Ensure site compliance with study protocol, SOPs, and regulatory guidelines• Build and maintain effective relationships with investigators, coordinators, and site staff• Perform source data verification (SDV) and ensure data accuracy and integrity• Identify, document, and follow up on data queries and monitoring findings• Support preparation and submission of regulatory documents to ECs and authorities• Monitor and report adverse events and ensure timely safety reporting• Collaborate with data management teams for accurate data collection and validation• Provide training and ongoing support to site staff throughout the study lifecycle• Act as a key point of contact between sites and internal cross-functional teamsQualification• Bachelor’s degree in Life Sciences or a related fieldExperience• Minimum 3 years of experience as a Clinical Research Associate• Hands-on experience in site management and clinical trial monitoring• Proven exposure to end-to-end clinical trial activitiesSkills• Strong knowledge of ICH-GCP and regulatory requirements• Excellent verbal and written communication skills• Strong organizational and time management abilities• High attention to detail and problem-solving skills• Ability to work independently and within cross-functional teams• Willingness to travel to investigative sites as requiredAbout the OrganizationMS Clinical Research Pvt Ltd is a leading clinical research organization committed to advancing scientific innovation through high-quality clinical trials. The company focuses on regulatory-compliant research practices to support the development of safe and effective medical solutions that improve healthcare outcomes.

Roles & Responsibilities• Support development and maintenance of Clinical Trial Registry (CTR) systems and processes• Ensure compliance with global clinical trial transparency regulations and reporting requirements• Coordinate accurate and timely posting of clinical trial protocol details and study results• Collaborate with medical, regulatory, biostatistics, and clinical development teams across regions• Maintain monitoring systems and metrics to track CTR compliance• Review and validate registry content for accuracy, consistency, and regulatory alignment• Manage multiple studies and priorities while meeting strict timelines• Support audits and inspections related to clinical trial transparencyQualification• Bachelor’s degree in scientific, health, communications, technology, or related field• OR Bachelor’s degree in any discipline with a minimum of 2 years of clinical development experienceExperience• Experience working with Clinical Trial Registry (CTR) processes preferred• Exposure to medical writing, regulatory affairs, biostatistics, or clinical research is an advantage• Experience working across multiple functional areas in clinical developmentSkills• Excellent command of English language, both written and spoken• Strong end-user computer skills (MS Word, Excel, PowerPoint)• High attention to detail with strong verbal reasoning and analytical thinking• Effective project and time management skills with ability to manage competing priorities• Ability to work independently as well as collaboratively in global teams• Strong interpersonal, negotiation, and stakeholder management skills• Ability to work across cultures, time zones, and dynamic environments• Comfortable dealing with ambiguity and driving tasks to completionAbout the OrganisationRecruise is a talent solutions and recruitment organization supporting global life sciences and healthcare companies by connecting skilled professionals with impactful roles across clinical research, regulatory affairs, and medical domains.

Roles & Responsibilities• Contribute at different levels to execution of Evidence Synthesis projects, including search strategy development, screening, and data extraction• Develop a comprehensive understanding of disease areas and treatment paradigms through primary and secondary research• Independently generate evidence to support selection, development, and implementation of fit-for-purpose COA instruments• Perform gap analyses, statistical analyses, psychometric validation, and dissemination of COA evidence• Prepare scientific documents such as reports, regulatory documents, and publications for internal and external use• Support COA endpoint strategies aligned with Best-in-Class / First-in-Class product development• Act as a subject matter expert (SME) to guide team members in executing COA-related projects• Identify opportunities to innovate COA value identification, evidence generation, and dissemination processes• Contribute to Target Value Propositions with patient-centric outcomes and value messaging• Develop and maintain strong expertise in COA science and methodologies• Collaborate effectively with global COA leads across multiple time zones• Lead or support literature reviews, qualitative research, COA landscape analyses, and instrument validation studies• Support development of COA dossiers and provide strategic input• Contribute to development of COA evidence generation processes, templates, and standards in line with FDA and EMA guidance• Work closely with HEVA, RWE, Clinical, Medical Affairs, Marketing, External Affairs, and Market Access teams• Prepare customized COA deliverables for global and local stakeholdersQualification• Advanced degree in Life Sciences, Pharmacy, Public Health, Psychology, or related disciplineExperience• Minimum 5+ years of experience in COA science• Experience in COA data analysis, COA instrument development or validation, and endpoint strategy• Experience in pharmaceutical industry, CRO, consultancy, or academiaSkills• Strong analytical skills to synthesize qualitative and quantitative data• Expertise in COA methodologies, psychometric validation, and patient-centered outcomes• Excellent scientific writing and communication skills• Stakeholder management and cross-functional collaboration• Ability to work independently and lead projects in a global environment• Exceptional proficiency in written and spoken EnglishAbout the OrganisationSanofi is a global biopharmaceutical company dedicated to chasing the miracles of science, fostering innovation, inclusivity, and long-term career growth while delivering patient-focused healthcare solutions worldwide.