Associate Director, Clinical Data Management

Key Responsibilities

Project Management and Leadership:
Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects. Efficiently plans, coordinates, and delivers complete, high‑quality and reliable clinical trial data in a timely manner for assigned projects. Responsible for end‑to‑end clinical data management activities and serves as a primary point of contact for internal and external study team members.

May act as a driver to set program‑level data collection and review standards with cross‑functional teams in partnership with global standards. Provides strong quality and project oversight over third‑party vendors responsible for data management deliverables. Takes a leadership role to gather content and integration requirements for EDC and partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes.

Authors, reviews, or revises data‑management‑related study plans including the Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization. Chairs Data Quality Review meetings with cross‑functional study team members to ensure ongoing review of trial data currency, quality, and completeness. Represents data management on cross‑functional project teams and submission teams.

Leads or supports Health Authority inspections, audits, and CAPA implementation. Provides coaching and quality oversight of junior data management leads. Leads or co‑chairs the department data management lead forums. Provides FSP/CRO/vendor oversight, manages data currency throughout the trial, and monitors data management deliverables according to the Service Level Agreement (SLA). Acts as a functional representative and point of contact for CROs and preferred vendors.

Supports continuous improvement initiatives and change‑management initiatives with broad impact as a lead or participant in initiatives, and/or authors (or participates in) functional SOPs/WP/GD. Utilizes knowledge of data‑management processes to evaluate and recommend new technologies and systems for improved data‑management functionality.

Can work collaboratively on multidisciplinary project teams and develop productive relationships with external vendors. Sound knowledge of clinical drug development processes, FDA/ICH guidelines, and industry standard practices regarding data management. Strong knowledge and experience of EDC systems (Medidata RAVE preferred). Demonstrated knowledge of Microsoft Office skills and well‑versed in industry trends and emerging technologies supporting data collection. Strong project management; exhibits expertise in metrics analysis and reporting methodologies.

Excellent oral and written communication skills. Communicates effectively with senior management and cross‑functional teams. Knowledge of submission requirements, e.g., New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA).

Bachelor’s Degree in life sciences, data science, or statistics is required; an advanced degree preferred. 7+ years of experience in biopharma/CRO with 3+ years in a study/program leadership role.

5–10% industry conferences, internal and investigator meetings, regulatory inspections (as needed).

Madison – Giralda – NJ – US: $170,800 – $206,968. The starting compensation range (for a full‑time employee) is listed above. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate accounts for required skills, job location, work schedule, job‑related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

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