Fulltime Position
Supports the Data Management team by managing Data Management personnel in the design, testing, and implementation of clinical data collection studies and the review of clinicial data in support of company objectives. Focuses on the oversight of quality data deliverables and projects with Contract Research Organizations in support of regulatory submissions, publications and due diligence activities.
Primary Responsibilities:
- Participates in the collaboration and coordination of the design and implementation of clinical protocols and data collection systems.
- Assists in the development of data quality plans.
- Ensures data management timelines for assigned projects are met.
- Supports strategic input into protocol design focused on data management issues.
- Assists Biostatistics in review of Statistical Analysis Plans.
- Reviews and resolves data discrepancies for standardized data validation systems and procedures.
- Oversees production of quality data deliverables for assigned protocols to support regulatory submissions, publications and due diligence activities.
- Participates in the review of clinical and regulatory documents, as needed, to assure data integrity and quality.
- Oversees projects that have been engaged with Contract Research Organizations (CROs), as well leads and manages internal projects.
- Assists with the development of standards and process documentation, including Standard Operating Procedures and Work Instructions.
- Supports compliance with industry quality standards, guidelines and procedures.
- Assists with the selection, development and evaluation of personnel to ensure the efficient operation of the function.
- Participates in providing suitable input into corporate and department budget process and management
- Assists in the career development of Data Management personnel.
- Other duties as assigned.
Education/Experience/Skills:
Bachelor's degree preferably in Life Sciences or Mathematics; an equivalent combination of education and applicable job experience may be considered. A minimum of 5 years progressively responsible experience in clinical data management in the pharmaceutical/ biotechnology/CRO setting with 2 years' experience in a leadership role.
Must possess:
- Previous experience managing/supervising others within a Data Management group
- Knowledge of medical terminology
- Knowledge of coding dictionaries (Medical Dictionary for Regulatory Activities -MedDRA, WHO Drug)
- Excellent verbal and written communication skills as well as interpersonal and organizational skills
- Proficiency in MS Office applications
- Proficiency with data management systems and knowledge and understanding of supporting statistical programs (e.g., SAS)
- Knowledge of database design and database concepts
- Demonstrated skill at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines. Able to gain cooperation of others.
- Proven skill at effectively leading a cooperative team effort and organizing resources to achieve team goals. Able to make and prioritize process and resource decisions based on overall team needs.
