2. Project team activities:

• Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting.

• Ensures medical activities run according to GCP and operate with highest efficiency

• Establishes and maintains a network of medical/scientific consultants, etc.
  

3. Clinical Activities:

• Interacts with cross functions regarding drug development programs, study design and protocol. Reviews and provides input for protocol development. Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints. Interacts in team approach to develop statistical and data management sections of the protocol. Reviews the final protocol for clinical, safety and efficacy variables.

• Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection.

• Develops project medical monitoring plans as requested. Provides on call coverage for protocol queries and site support. Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues.
  

4. Safety Monitoring and SAE Reporting Activities:

• Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study. Provides medical review of SAE reporting, reviews SAE narratives, and works with the Pharmacovigilance Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as needed.