Clinical Data Manager manages all aspects of clinical database design and reporting. Establishes and maintains policies and procedures for gathering, analyzing, and reporting clinical data. Being a Clinical Data Manager standardizes data management procedures and documents departmental operating procedures. May require an advanced degree. Additionally, Clinical Data Manager typically reports to a manager or head of a unit/department. The Clinical Data Manager typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Clinical Data Manager typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments.
Clinical Data Manager Job Description Template
Our company is looking for a Clinical Data Manager to join our team.
Responsibilities:
- Contribute to the development and implementation of departmental policies, standards and process improvement initiatives;
- Excellent written and verbal communication skills are required. Demonstrated proficiency with ICH, GCDMP, and GCP is required;
- Maintain and evaluate project progress by managing timelines and other tracking/analysis tools.
Requirements:
- At least 7 years of study and/or project level experience as a Data Manager in supportive and leading roles;
- Strong organizational skills and able to collaborate with minimal supervision;
- Deep understanding of the drug development process;
- The incumbent is required to conduct him/herself in an appropriate business manner adhering to a high ethical standard;
- Essential competencies identified include – Customer Focus, Drive Results, Manage Complexity, Plans & Aligns;
- Ability to work and lead effectively in a global environment;
- Significant experience of using data management methodologies and technologies (e.g., electronic data capture, familiar with data warehousing);
- Demonstrated understanding of regulations and guidelines (e.g. ICH, GCP, European Clinical Trials Directive, Privacy rules [HIPPA]);
- The incumbent can lead a study or project data management team independently;
- Knowledge and experience with Medidata and/or other EDC systems a plus;
- Project management and delegation skills;
- Capability of Medidata study building;
- Experience in CRO and vendor management required;
- Experience with all aspects of DM including Database Build, Study Startup, Study Conduct and Database Closure activities;
- Previous work experience in a diagnostic, medical device or pharmaceutical.