Job Opportunities

Duties and Responsibilities:

1. Serves as the HCRI contact with study sponsors on data management issues/activities and  coordinates the receipt and processing of information for projects (e.g., coding dictionaries, format libraries, and transfer database specifications) as well as electronic data received from specialty groups utilized on projects.
2. Establishes working relationships with sponsor's data management counterpart.
3. Oversees data received for in-house review via CRF tracking tools.
4. Coordinates the receipt and processing of electronic data received from specialty groups utilized on projects (e.g., data received from central laboratories.)
5. Coordinates the receipt and implementation of sponsor's coding dictionaries, format libraries, and transfer database specifications.
6. Establishes/negotiates DM timelines and ensures DM project milestones are met.
7. Coordinates the building and validation of HCRI clinical databases.
8. Is responsible for the development of standard and custom database status reports to meet the needs of HCRI project team and sponsor expectation.
9. Recognizes data management project issues needing to be brought to the attention of sponsor or other HCRI functional departments (i.e. clinical, safety, biometrics, and regulatory).
10. Directs/coordinates the activities of other CDM personnel, including other Clinical Data Managers, on assigned projects to ensure timely completion of high quality projects.
11. Is responsible for assisting in the training of Clinical Data Managers and other CDM personnel.
12. Is responsible for ensuring clinical databases are well-validated and ready for transfer and/or statistical analyses post database "freeze" and "lock.”
13. Coordinates paper and electronic archiving process for completed projects.

Requirements:
• Qualified candidates should have a minimum of a Bachelor's degree in a life science, nursing, computer science, or related discipline and a minimum of (5) year's experience working with clinical trial data.
• Candidates should be knowledgeable regarding the data management function in new device/drug development.
• Familiarity with PC in the Windows environment with knowledge of ORACLE, SQL, Domain ClinTrial/Clintrace, and/or SAS is required.
• Knowledge of ICH/FDA guidance for Good Clinical Practice (GCP) is considered a plus.
 

Education: BA or BS required; MS or MA with studies in Life Sciences preferred.

Yrs. of related experience: 5 years of data management experience in the biopharmaceutical or medical device industry required.