Sr. Manager/ Associate Director, Data Management

Position Summary:

Senior Manager / Associate Director, Clinical Data Management to provide leadership and oversight of clinical data management activities across one or more development programs. This individual will be responsible for ensuring the quality, integrity, timeliness, and regulatory compliance of clinical trial data from study start-up through database lock and submission readiness.

Working closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, clinical pharmacology, Pharmacovigilance, Regulatory Affairs, Information Technology, and external partners, this role will serve as the Data Management lead for assigned studies and programs, driving data strategy, vendor oversight, process excellence, and inspection readiness to support informed decision-making and successful regulatory submissions.

Essential Duties and Responsibilities:

Clinical Data Management Leadership

• Lead clinical data management activities for assigned studies (especially for PK trials)  from protocol development through database lock and submission readiness; Serve as the primary point of contact for CROs and vendors, ensuring data are delivered on time, within budget, and in compliance with ICH-GCP guidelines
• Represent Data Management on cross-functional study teams, ensuring alignment of data management deliverables with study objectives, timelines, and regulatory requirements.
• Develop and execute study-specific data management strategies to ensure high-quality, analyzable clinical trial data.
• Oversee and maintain Data Management Plans (DMPs), data review plans, and other study-level documentation.

Database Design, Build, and Validation

• Collaborate with Clinical Development, Biostatistics, and Medical/Clinical Pharmacology teams to design and review electronic Case Report Forms (eCRFs).
• Develop and review database build specifications, edit check specifications, CRF completion guidelines, and validation plans.
• Lead User Acceptance Testing (UAT) activities and oversee database go-live readiness.
• Ensure databases are designed and validated in accordance with protocol requirements, CDASH standards, and industry best practices.

Data Review and Quality Oversight

• Lead ongoing PK data and other data review, discrepancy management, query generation and resolution activities.
• Establish and monitor data quality metrics to ensure data accuracy, consistency, completeness, and readiness for analysis.
• Oversee reconciliation activities including Serious Adverse Events (SAEs), laboratory data, medical coding, protocol deviations, and other external data sources.
• Manage MedDRA and WHODrug coding activities and ensure consistency across studies.
• Support database lock activities and final data transfers for statistical analysis and regulatory submissions.

Vendor and CRO Management

• Manage bioanalytical vendors for PK assay and ensure appropriate data collection to support PK clinical trial execution
• Provide oversight of CROs, EDC providers, specialty laboratories, and other external vendors responsible for data management deliverables.
• Participate in vendor selection activities, including RFP reviews and vendor assessments.
• Review vendor contracts, data transfer agreements, and service deliverables to ensure compliance with study and regulatory requirements.
• Monitor vendor performance, timelines, quality metrics, and issue resolution.

Cross-Functional Collaboration

• Partner closely with Biostatistics and Statistical Programming to support data review, SAP development, listings review, and submission readiness.
• Collaborate with Clinical Operations, clinical pharmacology, Safety, Regulatory Affairs, and Medical teams to ensure accurate and efficient data collection and reporting.
• Participate in study team meetings, providing data management updates, risk assessments, and recommendations.
• Support preparation and review of clinical study reports, tables, listings, and regulatory submission deliverables.

Process Improvement and Compliance

• Contribute to the development and continuous improvement of Data Management processes, SOPs, standards, and best practices.
• Ensure compliance with ICH-GCP, FDA regulations, CDISC/CDASH standards, GCDMP guidelines, and applicable company procedures.
• Support inspection readiness activities and participate in regulatory inspections and audits as needed.
• Mentor junior team members and contribute to the growth and development of the Data Management function.

Required Education and Experience:

• BS/BA degree in bioscience, engineering, computer science, medical training, or a related field; MS/MA degree preferred.
• Senior Manager: 6+ years (if MS/MA degree) or 9+ years (if BS/BA degree) of clinical data management or relevant experience within the biotechnology, pharmaceutical, or CRO industry.
• Associate Director: 9+ years (if MS/MA degree) or 12+ years (if BS/BA degree) of clinical data management or relevant experience within the biotechnology, pharmaceutical, or CRO industry.
• Experience leading data management activities from study start-up through database lock.
• Strong vendor and CRO oversight experience.
• Experience supporting regulatory submissions and inspection readiness activities.

Preferred

• Management of PK trial data and clinical pharmacology experience highly desirable.

Additional Skills, Knowledge, And/or Abilities:

• Deep understanding of clinical data management principles, processes, and industry standards.
• Working knowledge of ICH-GCP, FDA regulations, 21 CFR Part 11, CDISC/CDASH, SDTM, MedDRA, and WHODrug.
• Experience with EDC systems such as Medidata Rave or equivalent platforms.
• Experience with drug development and PK sample collection.
• Strong understanding of external data integrations, reconciliation processes, and database lock procedures.
• Excellent project management, organizational, and problem-solving skills.
• Strong verbal and written communication skills with the ability to influence cross-functional stakeholders.
• Ability to manage multiple priorities in a fast-paced, evolving environment.