Associate Director, Clinical Data Management Job Description Template
Our company is looking for a Associate Director, Clinical Data Management to join our team.
Responsibilities:
- Lead the data management partnership with CROs for studies in the Rare Disease therapeutic area;
- Work effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics and data review tools;
- Implement, track and review key performance indicators on data management activity across the Rare Disease program.
Requirements:
- Experience in regulatory GCP inspections/audits;
- Vendor management and oversight experience;
- Thorough command of FDA and ICH GCP guidelines to ensure the appropriate reporting of clinical trial data;
- Creative, capable problem-solver;
- Outstanding verbal and written communication skills, in addition to excellent organizational skills;
- Ability to manage multiple projects in a fast-paced environment;
- Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology;
- Cross collaboration proficiency with other departmental functions such as Biostatistics, Statistical Programming, and Pharmacovigilance;
- Strong technical skills across data platforms.