Job Description

Job Description

Role Summary

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.

Key Responsibilities

• 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.

Qualifications

• 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.

Preferred Attributes

• 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.

How to Apply:

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.

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