TKL Research is a full-service, international Clinical Research Organization (CRO) serving the pharmaceutical, biotechnology, medical device and consumer healthcare industries. We provide comprehensive clinical trial management services for Phase 1-4 clinical research studies, including an inpatient Phase 1 facility and outpatient specialized research clinics.
We are seeking a highly motivated Director, Clinical Monitoring for our growing organization!
This position is responsible for line management, oversight and execution of the operational aspects of clinical monitoring activities. Its functions include: a) manage multiple regional clinical monitoring teams to meet sponsor requirements and deliverables; b) work with regional monitors, clinical project management teams, and other departments to deliver quality services and to ensure standardization of performance across all projects; c) provide clinical monitoring insight on issues, major results, and recommend strategic direction to management; d) provide ongoing clinical monitoring planning, expertise, insight on issues and major results, and recommendations for strategic direction to management.
Responsibilities include, but are not limited to:
- Manage/oversee all operational aspects of clinical trials monitoring, including timely pre-study site qualification, site initiation, interim monitoring, and site closeout of clinical studies.
- Direct and manage clinical monitoring personnel to assure proper planning and timely monitoring execution in support of multi-center clinical trials.
- Participate in capabilities presentations and/or bid defenses with potential new sponsors and develop/maintain client relationships.
- Prepare reports and projections via continual assessment and tracking of staff utilization and allocation of resources.
- Provide senior management with timely updates on progress and changes in scope, schedule, and resources for clinical studies.
- Establish and implement processes/guidelines to ensure the smooth transition of documentation between departments (i.e., project management, data management, etc.).
- Assure department adherence to good scientific, ethical, and regulatory standards.
- Provide long-range strategic planning for clinical monitoring.
- Responsible for assisting business development with bid and proposal preparation.
- Manage allocation of department resources, set timelines and priorities, in order to serve the needs of external and internal clients.
Min Bachelor’s degree, preferably in life sciences. Advanced degree is a plus. Minimum 10 years relevant professional experience in the pharmaceutical industry, preferably in the CRO environment. Minimum 5 years direct management experience and a minimum of 5 years clinical monitoring experience. Certified Clinical Research Associate certification desired. Candidate must possess detailed knowledge of FDA regulations and GCP/ICH guidelines as they apply to the conduct of clinical research. Ability and willingness to travel (e.g., investigator meetings or monitoring visits) and knowledge of Microsoft Office Suite is a must. We are considering remote-based candidates for this opening. Home/Remote office experience is required.
We offer a competitive compensation package for full time employees, commensurate with your background and experience, including full benefits, 401(k) with match and a profit sharing plan.