What are the responsibilities and job description for the Senior Manager / Associate Director, Clinical Data Management position at Sironax?
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.