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 is 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 cross-functional teams, this role serves as the Data Management lead for assigned studies and programs, driving data strategy, vendor oversight, process excellence, and inspection readiness.

Essential Duties and Responsibilities

Clinical Data Management Leadership

• Lead clinical data management activities for assigned studies (especially PK trials) from protocol development through database lock and submission readiness.
• Serve as primary point of contact for CROs and vendors, ensuring compliance with ICH-GCP guidelines.
• Represent Data Management on cross-functional study teams.
• Develop and execute study-specific data management strategies.
• Oversee Data Management Plans (DMPs) and study documentation.

Database Design, Build, and Validation

• Design and review electronic Case Report Forms (eCRFs).
• Develop database build and edit check specifications.
• Lead User Acceptance Testing (UAT) and database go-live readiness.
• Ensure compliance with protocol requirements and CDASH standards.

Data Review and Quality Oversight

• Lead PK and clinical data review, discrepancy management, and query resolution.
• Monitor data quality metrics for analysis readiness.
• Oversee reconciliation of SAEs, laboratory data, coding, and external data.
• Manage MedDRA and WHODrug coding activities.
• Support database lock and final data transfers.

Vendor and CRO Management

• Manage bioanalytical vendors for PK assays.
• Oversee CROs, EDC providers, and specialty laboratories.
• Participate in vendor selection and contract review.
• Monitor vendor performance and quality metrics.

Cross-Functional Collaboration

• Partner with Biostatistics and Statistical Programming for SAP development and submission readiness.
• Collaborate with Clinical Operations, Safety, Regulatory, and Medical teams.
• Provide risk assessments and data management updates.
• Support clinical study reports and regulatory submission deliverables.

Process Improvement and Compliance

• Improve Data Management processes, SOPs, and standards.
• Ensure compliance with ICH-GCP, FDA, CDISC/CDASH, and GCDMP guidelines.
• Support inspection readiness and audits.
• Mentor junior team members.

Required Education and Experience

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

Preferred

• Management of PK trial data and clinical pharmacology experience.

Additional Skills, Knowledge, and Abilities

• Knowledge of ICH-GCP, FDA regulations, 21 CFR Part 11, CDISC/CDASH, SDTM, MedDRA, and WHODrug.
• Experience with EDC systems such as Medidata Rave.
• Experience with drug development and PK sample collection.
• Understanding of data integrations, reconciliation, and database lock procedures.
• Strong project management and organizational skills.