Job Description

Manage and develop clinical operations team consisting of Clinical Research Associates. Contribute to and oversee resource planning and assignments. Provide monitoring oversight to ensure all activities are conducted to the highest possible quality and in accordance with applicable directive documents and ICH/GCP standards.

of Responsibilities:

• Responsible for detailed performance review and management of assigned direct reports including Annual Performance Management and Development (PMD), Individual Development Plan (IDP), Line of Sight Goals and "Shoves and Tugs"
• Responsible for appropriate management and resolution of performance issues.
• Hold Clinical Operations staff accountable for quality and compliance with project plan and adherence to contract obligations in Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverables.
• Engage in resource management activities for direct reports.
• Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports.
• Measure performance indicators for assigned staff within Clinical Operations.
• Escalate potential individual training needs and assist in the conduct of training and development efforts, regionally.
• Effectively communicate management strategies, policies, and procedures in conjunction with leadership teams.
• Develop and maintain effective relationships with management team to manage Clinical Operations staff in a matrix environment.
• Conduct, report and follow up on Quality Control Visits (CQC).
• Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business.
• Provide oversight on monitoring activities associated with the site-level evaluation, initiation, patient recruitment and retention, monitoring and collection of data, and closeout of clinical trial sites.
• All other duties as needed or assigned.
• People Responsibilities: 5- 10 Direct Reports

Qualifications (Minimum Required):

• University/college degree - life sciences preferred or certification in a related allied health profession from an approximately accredited institution (e.g., nursing certification, medical or laboratory technology).
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• In lieu of this required education background the following relevant work history may be considered:
• Minimum of two (2) years supervisory experience in a health care of clinical research setting and
• Minimum of six (6) years relevant clinical research experience in a pharmaceutical company/CRO.
• Preferred: Master’s or other advance degree.

Experience (Minimum Required):

• Relevant clinical research experience in a pharmaceutical company or CRO:
• Individual is proficient with on-site monitoring activities (including pre-study, initiation, routine monitoring and closeout visits).
• Minimum of four (4) years relevant clinical research experience in pharmaceutical company/CRO.
• Thorough knowledge of drug development process.
• Thorough knowledge of relevant SOPs, ICH, and GCP guidelines.
• Phase I monitoring experience preferred.
• Relevant supervisory experience:
• Some experience as a Line Manager or Project Manager preferred.
• Demonstrated ability to lead by example and to encourage team members to seek solutions.
• Proven interpersonal skills.
• Demonstrated ability to successfully participate as a member of a project team.
• Demonstrated ability to successfully manage multiple competing priorities.
• Excellent planning and organizational skills.
• Excellent oral, written and presentation skills.

Physical Demands/Work Environment:

• General Office Environment or Home Based.
• Travel may be required Globally up to 25-50% of the time, with 100% of that time requiring an overnight stay.

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