To provide leadership, direction, and execution of necessary protocols in the Clinical Operations department.
Essential Duties & Responsibilities
- Partners with Clinical Research and Operations leads to successfully plan and implement clinical trials for assigned programs.
- Oversees vendor selection and management, including request for proposal, day-to-day operations, timeline supervision, study document generation, contract negotiation, budget management, etc.
- Forecasts study budget and actively manages in collaboration with finance department.
- Serves as Clinical Operations Lead in project team meetings.
- Ensures compliance with protocol and applicable regulations/GCPs.
- Contributes to the development of the Target Product Profile for assigned studies.
- Works collaboratively with Clinical Operations and Research leads, and other functional area project team members.
- Leads in process improvement initiatives to ensure best industry standards and approaches.
- Participates in resource planning, including identification of resource options across the assigned programs and resource analysis across the assigned programs.
- Reviews departmental SOP’s that are newly generated or revised, and oversees the implementation of finalized SOP’s.
Non-Essential Duties & Responsibilities:
- Presents at meetings such as Investigator Meetings.
- Coaches and mentors staff.
- Participates in special initiatives, as assigned.
- May provide leadership to Clinical Research Associates.
Knowledge & Other Qualifications:
- Minimum of BS/BA in a biomedical discipline, or equivalent education/training is required.
- BS with 6 years of experience in related field , or MS with 3 – 4 years of experience in related field, or Doctorate with 2 - 3 years of experience in related field (Ph.D/MD/PharmD/DVM).
- At least 3 years clinical operations and pharmaceutical business experience in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issues.
- Leadership, clinical project management, administrative, and technical capabilities are required.
- Effective verbal and written communication skills.
- Direct experience in clinical pharmacology/experimental medicine research studies/programs preferred.
- Ability to work independently and as part of a team.
- Ability to maintain high ethical standards of integrity and quality.
- Capable of being innovative and dynamic in approach to work.
- Capable of performing other duties as assigned by management.
- Authorized to legally work in the United States without visa sponsorship.
Physical Requirements / Work Environment
- Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
- The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading
- The worker is not substantially exposed to adverse environmental conditions