Job Description :
- Independently performs all data management functions to ensure timely and quality database lock for studies.
- Perform data management activities for EDC studies conducted in-house as well as oversee activities of off-shore CRO handling outsourced projects (protocol review, CRF development, database set-up activities, data validation process; medical coding, SAE reconciliation, etc...)
- Minimum 3 plus years of experience in Clinical Data Management within pharma or CRO environment.
- Bachelor degree or above in scientific or related field required. Commensurate experience in Data
- Management may be considered.
- Hands-on experience conducting all DM activities and possess strong project management and excellent interpersonal skills to independently manage a global project. Must have experience with EDC, Inform preferred but open to other EDC such as RAVE, etc.
- Experience in some Oncology preferred.
- Knowledge of I-Review/J-Review a plus.
- Proficiency on all related regulations, GCP, and Good Clinical DM Practice.
- Computer proficiency and knowledge of medical terminology.
- Strong oral and written communication skills
SOFT SKILLS :
- Seeking candidates, who are willing to learn, are motivated, enthusiastic and who are team players.
- Someone who has an innate ability to take initiative, problem solves, meet deadlines, etc.
PLEASE NOTE :
- Your candidates must be able to back up what is on their resume. We strongly suggest you screen and interview your candidates thoroughly and perform reference checking as indicated in your contract.
- Also we want to see longevity in previous positions.
- If multiple positions – explain in detail in your summaries.