Job Description

Summary / Job Purpose

The Associate Director, Clinical Data Management (CDM) will provide strategic oversight and leadership for data management activities across one or more clinical programs from study initiation through regulatory submission. This role ensures high-quality data deliverables are met on time, within scope, and in compliance with regulatory standards. Working in close collaboration with cross-functional teams and external vendors, the Associate Director will serve as a subject matter expert and mentor, while driving operational excellence and process improvements in clinical data management.

Essential Duties and Responsibilities

• Serve as the primary point of contact for data management at the program level.
• Lead cross-functional planning and execution of CDM deliverables across multiple studies.
• Provide strategic input on data management timelines, resources, and risks.
• Lead and coordinate Data Working Group (DWG) meetings for assigned studies/programs.
• Oversee and ensure timely development and archival of essential DM documents (e.g., DMP, CRFs, edit checks, coding dictionaries).
• Provide expert guidance and support for data collection design, data quality review, SAE reconciliation, and third-party data integrations.
• Drive data cleaning strategy and database lock readiness in collaboration with clinical and biostatistics teams.
• Manage data flow and transfer processes, including oversight of CROs and other external vendors.
• Lead cross-functional meetings to ensure alignment and proactively resolve data-related issues.
• Champion data standards including CDASH/CDISC compliance.
• Oversee submission-ready data delivery including preparation of datasets for regulatory submissions.
• Provide direction to junior data managers and cross-functional contributors, ensuring consistency and quality.
• Collaborate on hiring, onboarding, training, and mentoring of CDM team members.
• Lead and contribute to department-level process improvement initiatives.
• Participate in vendor selection, RFP processes, and performance oversight.
• Ensure compliance with GCP, regulatory requirements, and internal SOPs.

Education & Experience:

• Bachelor’s degree in life sciences or related discipline; advanced degree preferred.
• Minimum of 11 years of relevant clinical data management experience in the pharmaceutical, biotech, or CRO industry.
• At least 4 years in a CDM project leadership or program-level role.
• Demonstrated experience with electronic data capture (EDC) systems; knowledge of Medidata Rave, Oracle Inform, or similar platforms strongly preferred.
• Familiarity with IVRS/IWRS systems is a plus.

Skills & Knowledge:

• Strong project management skills, with ability to manage multiple priorities.
• Deep knowledge of clinical data standards, GCP, and regulatory expectations.
• Expertise in CDASH, CDISC, and regulatory submission standards (e.g., SDTM).
• Proficiency in managing CROs and third-party data providers.
• Exceptional written and verbal communication skills.
• Strong interpersonal and leadership skills with a collaborative mindset.
• Strategic thinker with strong problem-solving abilities and attention to detail.

Work Environment:

This is a 5-day per week onsite role based in the East Bay, CA area. Candidates must be local or willing to relocate.

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