MD Clinical Research Physician
Trenton Metro Area, New Jersey
MD in a relevant field equivalent advanced degree, with experience in clinical research and development. 2-5 years clinical drug development process experience preferred.
Knowledge of and strict adherence to GCP/ICH guidelines and internal SOPs in Clinical Research and Development. Must have experience with study start up and database locks.
The Clinical Research Physician manages and supervises the clinical, scientific, administrative, and technical activities required to conceive, and execute clinical studies within the department with emphasis on overall clinical study leadership. This work is carried out at the direction of senior management in line with departmental strategic goals. This person also ensures quality, timely and coordinated clinical study activities wand ensures compliance with the appropriate GCP/ICH and health authority guidelines. This individual provides clinical development expertise on behalf of the company at appropriate academic centers, medical and regulatory meetings. The Clinical Research Physician also is responsible for assisting senior management, in establishing and achieving long-term Corporate Strategic goals and tactical objectives.
1. Provides leadership to the clinical study team involved in the execution of clinical studies.
2. Oversees and is responsible for the quality, coordination and timeliness of protocol development.
3. Oversees and is responsible for the quality, coordination, medical accuracy and timeliness of clinical study reports.
4. Assists senior management to oversee quality, coordination and timeliness of clinical sections of INDs, Investigator Brochures, CTAs, ISS's, ISE's, and clinical expert reports.
5. Participates, as required, as a clinical representative on Project Teams.
6. Establishes and maintains working relationship with Study investigators, key opinion leaders, academicians, and Senior managers and department heads across the corporation.
7. Ensures adherence to GCP/ICH and SOP standards.
8. Maintains clinical and scientific awareness in area of expertise. Supports clinical operations in site selection, study budget preparation, study execution and addresses clinical/medical issues at study sites.
9 Participates in the organization, coordination and execution, as required, of internal meetings and external medical/scientific meetings, e.g., Investigator Meetings and clinical/scientific advisory board meetings.
10. Develops and gives oral presentations, as required.
11. Supports data management as required for CRF development, database edit checks development, listings review, query resolution, database clean-up and lock activities.
12. Prepares clinical study timelines and status reports, as required, per Supervisor.