What’s the opportunity?
Reporting initially to the Chief Medical Officer, the Associate Director, Data Management will serve as a key individual contributor responsible for leading and executing clinical data management activities across one or more clinical programs. This role will partner closely with key functions including Clinical Development, Clinical Operations, and external CROs to ensure high-quality, trial-ready data that supports LifeMine's clinical and regulatory objectives.
Key Responsibilities
- Serve as the Data Management lead on assigned clinical trials, overseeing all CDM activities from study startup through database lock.
- Develop, review, and maintain key data management documents including the Data Management Plan (DMP), eCRF specifications, data validation plans, and edit check specifications.
- Design and review electronic Case Report Forms (eCRFs) in collaboration with clinical, biostatistics, and medical teams.
- Lead CRO and vendor oversight for data management activities, ensuring deliverables are met on time and to quality standards.
- Develop and implement data review strategies including ongoing data cleaning, query management, and medical coding oversight (e.g. MedDRA, WHODrug).
- Collaborate with Biostatistics on the development of the Statistical Analysis Plan (SAP), TFL shells, and interim analysis deliverables.
- Support data transfers and reconciliation with external data vendors including central labs, ePRO/eCOA vendors, and pharmacokinetics providers.
- Ensure compliance with applicable regulations, guidelines, and industry standards including ICH E6(R2), 21 CFR Part 11, and CDASH/CDISC standards.
- Contribute to database lock activities including final data review, query resolution, and lock certification.
- Participate in regulatory submissions by providing data management input into clinical study reports (CSRs), INDs, BLAs, and NDAs.
- Partner with Clinical Operations to support site initiation visits (SIVs) and investigator meetings with DM-related content and training.
- Contribute to the development and continuous improvement of data management SOPs, processes, and best practices.
What you will need to be successful
- Bachelor's degree in life sciences, data science, or a related field required; advanced degree preferred.
- 8-10 years of clinical data management experience in the biotechnology or pharmaceutical industry.
- Demonstrated experience as a DM lead on Phase 1–3 clinical trials, including full lifecycle from study startup to database lock.
- Proficiency with EDC platforms (e.g., Medidata Rave, Medrio).
- Strong working knowledge of CDISC standards (CDASH, SDTM) and regulatory requirements (ICH E6, 21 CFR Part 11).
- Experience with CRO oversight and management of external data vendors.
- Familiarity with medical coding conventions (e.g. MedDRA, WHODrug).
- Strong attention to detail with excellent written and verbal communication skills.
- Ability to work independently and manage multiple priorities in a fast-paced, dynamic environment.
- Experience in transplantation or immunology a plus.
- Willingness to travel up to 10–15% as needed.