Clinical Database Management (Project Management)

Why This Role Matters

The Manager – Clinical Database Management plays a strategic role within Clinical Data Sciences (CDS), ensuring high-quality clinical database design, development, and lifecycle management across assigned studies and therapy areas. In modern drug development, reliable and standardized clinical data systems are essential for regulatory submissions, safety reporting, and data-driven decision-making.
This role ensures operational excellence in database build, change control, and data capture technologies while maintaining strict compliance with regulatory standards and internal SOPs. By leading database management initiatives and collaborating closely with Clinical Data Scientists, the position directly contributes to data integrity, submission readiness, and portfolio success.
At Pfizer, Clinical Data Sciences professionals play a key role in accelerating innovation through structured, compliant, and technology-driven clinical data management.

Job Description

The Manager – Clinical Database Management is responsible for providing project management leadership and technical expertise in clinical database design and maintenance within the Clinical Development & Operations organization.
The role oversees the database development cycle, ensures effective change control management, and maintains integrity and consistency of clinical data aligned with Pfizer standards. The candidate will serve as a Subject Matter Expert (SME) for database build activities within assigned therapy areas and ensure seamless collaboration between Database Management (DBM) and Clinical Data Scientist functions.
This is a hybrid work location assignment within a global, cross-functional clinical operations environment.

Key Features of the Role:

• Position: Manager – Clinical Database Management
• Department: Clinical Data Sciences (CDS)
• Experience Required: Minimum 10 years in clinical data/project management
• Industry: Pharmaceutical / Biotech / CRO / Regulatory
• Focus: Clinical database design, development, and lifecycle management
• Expertise in EDC systems and clinical data platforms
• Hybrid work model
• Leadership and mentoring responsibilities

Responsibilities

• Manage the development cycle of data capture solutions supporting study data review plans
• Oversee database build, implementation, and change control processes
• Ensure integrity, quality, and compliance of clinical databases
• Serve as project management resource to study teams for database development planning
• Identify risks proactively and develop mitigation strategies
• Perform impact analysis for proposed tool/process changes
• Solve moderately complex database build and implementation challenges
• Lead operational activities supporting short-term departmental goals
• Represent Database Management in Clinical Data Sciences initiatives
• Ensure compliance with SOPs and work practices
• Collaborate with Clinical Data Scientists to ensure seamless CDS deliverables
• Support standardization and consistency across asset/submission data
• Assess change control impacts and implement mitigation plans
• Drive process improvements and innovative solutions
• Mentor junior staff members when required
• Participate in Pfizer Standards meetings and cross-functional governance forums

Required Qualifications

Candidates must demonstrate strong expertise in clinical database management, project leadership, and regulatory data standards.

Educational Requirements:

• Bachelor’s degree in Life Sciences, Computer Science, or equivalent (Mandatory)

Experience and Skills:

• Minimum 10 years of project management experience in pharmaceutical, biotech, CRO, or regulatory settings
• Strong experience in building data collection and assimilation solutions
• Proficiency in Electronic Data Capture (EDC) systems
• Experience with Clinical Data Management Systems such as Oracle InForm, Data Management Workbench
• Familiarity with relational databases (MS SQL Server, MS Access)
• Experience with data visualization tools such as Spotfire and J-Review
• Hands-on experience with MS Project or enterprise project management tools
• Strong communication, influencing, negotiation, and decision-making skills
• Understanding of drug development processes and clinical data operations
• Knowledge of regulatory requirements and CDISC standards (preferred)
• Proficiency in Microsoft Office Suite

Salary Insights

Compensation will be competitive and aligned with senior-level clinical data management roles within global pharmaceutical organizations. Salary may vary depending on experience in database technologies, regulatory standards, and leadership responsibilities. Additional benefits and hybrid flexibility are provided as per company policy.

Company Overview

Pfizer is a global biopharmaceutical leader committed to discovering and delivering innovative medicines and vaccines. The Clinical Data Sciences group is an integral part of the Clinical Development & Operations organization, supporting high-quality clinical data solutions that drive regulatory approvals and patient safety worldwide.
Pfizer promotes diversity, innovation, operational excellence, and compliance while offering professionals opportunities to grow within a global healthcare environment.

FAQs

Q1. Is prior clinical database management experience mandatory?
Yes, extensive experience in clinical database build and project management is required.

Q2. Is knowledge of EDC systems necessary?
Yes, familiarity with Oracle InForm or similar systems is essential.

Q3. Does the role involve leadership responsibilities?
Yes, the role includes leading initiatives and mentoring junior team members.

Q4. Is CDISC knowledge required?
It is preferred but not mandatory.

Q5. Is this a remote role?
No, this is a hybrid work model position.

Application Tip

• Highlight experience with Oracle InForm or similar EDC platforms
• Mention global clinical trial database management exposure
• Showcase project management tools and methodologies used
• Demonstrate knowledge of CDISC and regulatory submission standards
• Provide examples of risk mitigation and change control management
• Emphasize leadership and cross-functional collaboration experience