Director, Clinical Data Management Job Description Template
Our company is looking for a Director, Clinical Data Management to join our team.
Responsibilities:
- Ensure compliance from a CDM perspective regarding protocols, SOPs and overall clinical objectives; develops SOP as needed;
- Evaluate and select CDM vendors; lead vendor activities for clinical trial data collection to ensure quality and timely deployment;
- Oversee identifying, locating, evaluating and validating CDM documents and databases required for report generation or regulatory submission;
- Generate data listings or other data review tools for reporting of study metrics;
- Other related duties as assigned;
- Manage interface with CROs, clinical sites and laboratories to ensure the efficient and timely collection of clinical data;
- Support clinical study report creation with input to the data quality assurance section as well as provisioning of sample and completed eCRFs, etc.
Requirements:
- Bachelor’s or master’s degree in related field;
- 10+ years of clinical data management experience;
- Ability to travel domestically and internationally up to 10%
- Good? understanding ?of database and dictionary structures (e.g., MedDRA);
- Expert knowledge of industry leading eCRF tools;
- 6+ years of supervisory and management experience;
- Good Clinical Data Management Practices (GCDMP)? understanding;
- Good Clinical Practices ICH GCP guidelines? understanding.