Senior Manager​/Associate Director, Clinical Data Management

Senior Manager / Associate Director, Clinical Data Management

The Senior Manager / Associate Director of Clinical Data Management (CDM) will lead and oversee clinical data management activities across Sironax clinical programs, ensuring the delivery of high‑quality, compliant, and timely clinical trial data. This role serves as a hands‑on leader and subject matter expert, partnering closely with Clinical Development, Biometrics, Medical, Regulatory, and external vendors (CROs) to support decision‑making and regulatory submissions.

The level (Senior Manager vs Associate Director) will be determined based on experience and scope of responsibility.

• Provide operational and strategic leadership for clinical data management activities across Phase I–III (and IV as applicable) studies.
• Develop, review, and maintain Data Management Plans (DMPs), CRFs/eCRFs, edit checks, and data review strategies.
• Oversee database build, UAT, data cleaning, medical coding, and database lock activities.
• Ensure compliance with global regulatory requirements including ICH‑GCP, 21 CFR Part 11, and GCDMP.
• Manage and oversee CROs and data vendors, including scope definition, oversight, performance tracking, and issue resolution.
• Apply risk‑based data management and quality oversight methodologies to proactively identify and mitigate data risks.
• Serve as the data management representative on cross‑functional study teams and governance forums.
• Support inspection readiness and participate in audits and regulatory interactions as needed.
• Contribute to the development and continuous improvement of CDM SOPs, standards, and best practices.
• Mentor and guide junior data management staff and provide functional leadership as the organization grows.

• Bachelor’s degree or higher in life sciences, statistics, computer science, or a related field.
• 8–10+ years of clinical data management experience within biotech, pharmaceutical, or CRO environments.
• Demonstrated experience managing end‑to‑end CDM activities for multiple clinical trials.
• Strong working knowledge of EDC systems, eCOA, IRT, and data integrations.
• Hands‑on experience with CDISC standards (CDASH, SDTM) and data readiness for regulatory submissions.
• Experience managing CROs and external vendors in a sponsor oversight model.
• Strong communication, leadership, and cross‑functional collaboration skills.

• Experience supporting IND, NDA, or BLA submissions.
• Prior experience in a small or mid‑sized biotech environment.
• Ability to operate both strategically and tactically in a fast‑paced development setting.

If you meet the above criteria and are excited by the opportunity to join our team, please submit your application directly.

Please note: We are not accepting applications or outreach from recruitment agencies for this role. All candidates must apply directly.

Mid‑Senior level

Full‑time

Science