Clinical Site Director / Sr Clinic Director (Phase1)

About the Role

The Senior Clinical Site Director is responsible for the management, administration, and organization of local site operations for a Clinical Pharmacology unit, and may oversee multiple sites. This role ensures the overall performance of the site(s), meeting defined metric goals and the needs of Sponsors. The Senior Director serves as a lead member of the site leadership team, ensuring efficient utilization of all resources, both human and physical, and partners on improvement initiatives to maintain consistent operational practices across all sites.

Responsibilities

• Provides supervision and leadership for the assigned site, including implementation of performance standards, performance reviews, and succession planning.
• Identify the current and desired culture of the site and partner with HR to modify or sustain the culture as appropriate.
• Ensure that site organizational structure and staff levels are adequate to meet flexible workload needs and budget expectations.
• Ensure robust training plans for onboarding new staff and maintaining continued technical competence.
• Ensure staff is adequately and consistently trained to meet quality standards, protocol expectations, SOPs, and forecasted workload.
• Coach and mentor staff to meet competency expectations; initiate, plan, and implement appropriate staff development and disciplinary programs.
• Instill Fortrea’s commitment to business integrity and quality to meet client requirements without error, on time, every time.
• Partner with CPS Finance Partners in the development of the site operating budget.
• Ensure appropriate cost monitoring systems are in place and maintain accurate project accountability.
• Work with assigned Clinic Directors and liaise with the local business community to develop new therapeutic areas to meet client needs and strategic objectives.
• Ensure the assigned site has a system to review proposals for feasibility and complete site assessments within 24 hours of protocol review requests.
• Work with business leadership to drive strategic expansion opportunities for the assigned site.
• Proactively work with Quality Assurance, Medical, Legal, and other departments to obtain information and make sound decisions to drive continuous process improvements.
• Continually investigate and implement state-of-the-art processes and systems to ensure the safety, welfare, and dignity of volunteers.
• Ensure all work is carried out in strict accordance with relevant protocols, Standard Operating Procedures, and in compliance with Good Clinical Practices.
• Ensure staff has access to appropriate information and that scientific and medical standards are met.
• Develop strategies for efficient study conduct, data collection, subject management, and safety monitoring; coordinate interdepartmental efforts to accomplish these strategies.
• Initiate procurement of external resources, consultants, or equipment when required by protocol.
• Ensure full and accurate study data records are maintained.
• Ensure all training files are up to date and complete in accordance with SOPs and ICH/GCP.
• Maintain a safe working environment and ensure safe working practices are employed.
• Take a leadership role in problem resolution and process improvement when customer error occurs; follow up on assigned sites with QA and CAIRS.
• Continuously seek new and better ideas, share best practices, and ensure the site benchmarks with other sites to maintain consistency of operations.
• Participate in and support global operational decisions and ensure site compliance.
• Proactively work with Client Services and Sales departments to make sound decisions supporting site strategies and financial goals.
• Present site capabilities to clients at Fortrea and/or assigned site when required.
• Ensure the highest levels of client service are maintained as indicated by NPS scores and other client feedback methods.
• Work with multiple sites to develop robust long-term solutions to proactively address client concerns and protocol deviations.
• Assist the site in making recommendations for timing, logistics, and feasibility for proposed studies.
• Ensure the assigned site meets the overall schedule agreement with the client.
• Ensure there is a responsible manager/resource at each site to host/manage client visits and agency audits.
• Perform all other duties as needed or assigned.

Requirements

• University/four-year college degree — Bachelor of Science (BS) in medical or science or related field. Fortrea may consider relevant and equivalent experience and successful project outcomes in lieu of educational requirements.
• 10 to 12 years of progressive and proven leadership responsibilities in a related business environment.
• Expert knowledge of Phase I clinical research.
• Creative and resilient in the application of processes and approach to work; comfortable dealing in a complex environment.
• Successful track record in meeting commitments and driving change, using a highly collaborative approach, and emphasizing team wins versus individual achievement.
• Valid driver’s license appropriate for the country of residence and role requirements, with a clean driving record.
• Ability to read and interpret maps, GPS systems, and delivery instructions.

Work Environment

• Work is performed in a laboratory and/or clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations; occasional domestic travel.
• Exposure to biological fluids.
• Personal protective equipment required, such as protective eyewear, garments, and gloves.

Physical Requirements

• Ability to work in an upright and/or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
• Occasional crouching, stooping, with frequent bending and twisting of the upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.