Senior Clinical Site Director

Job Overview:

The Senior Clinical Site Director is responsible for the management, administration, and organization of local site operations for a Clinical Pharmacology unit, may take on responsibility for multiple sites. Responsible for the overall performance of the site(s), meeting defined metric goals and meeting the needs of Sponsors. The Senior Director serves as a lead member of the site leadership team and is responsible for ensuring efficient utilization of all resources, both human and physical, allocated to the group. This role works to partner on improvement initiatives and works closely with other Clinic Directors to ensure consistent operation practices are implemented at all sites.

Summary of Responsibilities:

Leadership:

• 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 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 meet budget expectations.
• Ensure that training plans are robust for onboarding of new staff and continued technical competence. Ensure staff is adequately and consistently trained to meet the quality standards, protocol expectations, SOPs and forecasted workload at assigned site.
• Coach and mentor staff to meet competency expectations. Initiate, plan and implement appropriate staff development and disciplinary programs.
• Instill in all team members Fortrea’s commitment to business integrity and quality to meet the client's requirement without error, on time, every time.

Financial:

• Partner with the CPS Finance Partners in development of site operating budget.
• Ensure that appropriate cost monitoring systems are in place and that accurate project accountability is maintained.
• Work with assigned Clinic Director's and liaise with the local business community to develop new therapeutic areas for the site to meet client needs and strategic objectives.
• Ensure that assigned site has a system in place to review proposals for feasibility and complete site assessment within 24 hours of protocol review requests.
• Works with business leadership to drive strategic expansion opportunities for assigned site.

Process:

• Proactively work with Quality Assurance, Medical, Legal and other departments to obtain information and make sound decisions to drive continuous process improvements at assigned site.
• 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 the relevant protocols, Standard Operating Procedures, and in compliance with Good Clinical Practices.
• Ensure staff has access to appropriate information.
• Ensure that scientific and medical standards are met.
• Develop strategies for efficient study contact, data collection, subject management, and safety monitoring. Coordinates efforts interdepartmentally to accomplish these strategies.
• Initiate procurement of external resources, consultants, or equipment when protocol required.
• Ensure that full and accurate study data records are maintained.
• Ensure that all training files are up to date and complete in accordance with SOPs and ICH/GCP.
• Ensure that safe working environment is maintained and that safe working practices are employed.
• Take a leadership role in problem resolution and process improvement when customer error occurs. Follows up on assigned sites with QA and CAIRS.
• Continuously seeks out new and better ideas, share best practices and ensures that assigned site is benchmarking with other sites and maintaining consistency of operations.
• Participate in and support global operation decisions and ensure site compliance.

Clients:

• Proactively work with Client Services and Sales departments to make sound decisions to support site strategies and financial goals. May be asked to present site capabilities to clients at Fortrea and/or assigned site.
• Ensure that the highest levels of client service are maintained as indicated by NPS scores and other client feedback methods.
• Works with multiple sites to develop robust long-term solutions to proactively address client concerns and protocol deviations.
• Assists site to make recommendations for timing, logistics and feasibility for proposed studies, when needed.
• Ensures that assigned site meets the overall schedule agreement with the client.
• Ensures there is a responsible manager/resource at each site to host/manage client visits and agency audits.
• All other duties as needed or assigned.

Qualifications & Experience (Minimum Required):

• 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.
• Must be creative and resilient in application of processes and approach to work, and 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.
• Must be creative and resilient in application of processes and approach to work, and 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 and have 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 a 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 upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

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