Qualifications
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- Bachelor’s degree requited, preferably in scientific discipline.
- Incumbent typically will possess 0 to 3 years of Clinical Operations/Filing documents experience in TMF Operations.
- Knowledge of filing procedures and eTMF application is mandatory.
- Experience in Veeva is desirable.
- Competent computer skills including ability to take on board new systems.
- Capability of managing competing priorities in a changeable environment and ability to handle stressful situations/deadlines.
- Thorough knowledge of GCP and TMF governing regulations, such as the TMF Reference Model required.
- Experience in NIH-sponsored clinical programs is a plus.
- Assertiveness, technical background, integrity.
