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About the Role
Oversee, train, resource, coach, and performance manage a team of clinical operations staff, focusing on end results using metrics and KPIs. Act as the point of escalation for performance and training needs, ensuring adherence to company SOPs and WPDs. Collaborate with the leadership team for resourcing needs.
Responsibilities
- Manage staff, providing coaching, mentorship, and work direction.
- Conduct regular performance appraisals and career discussions with staff.
- Facilitate employee career development.
- Interview, recruit, and select staff.
- Manage and conduct induction/orientation programs for new employees.
- Ensure all staff CVs, training records, position profiles, and experience profiles are complete and up-to-date.
- Ensure timeliness and accuracy of timesheets and expense reports.
- Support allocation activities per the local resourcing process.
- Support project leads/functional leads to optimize project operations.
- Raise issues that may impact project deliverables.
- Deliver training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements, and other clinical operations subjects.
- Identify training gaps and ensure training requirements are met.
- Contribute to the development of training programs.
- Assure adherence to good ethical and regulatory standards.
- Alert management to quality issues, request QA audits, and facilitate client and internal quality assurance audits.
- Handle and review systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs, and project status.
- Evaluate work of staff, including conducting PAVs (remote or on-site) to evaluate employee monitoring skills and project conduction.
- Participate in process improvement/development initiatives.
- Ensure understanding and facilitation of the risk-based monitoring approach.
- Provide input into bids and contribute to the procurement of new business.
- Collaborate with clinical operations senior management and executive staff on strategic planning and business development.
- Lead or contribute to initiatives that enhance department performance or lead to process improvement across the company.
Requirements
- Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
- 1+ year of leadership responsibility.
- Ability to travel as needed.
Skills
- Advanced mentoring/leadership/supervisory skills
- Excellent clinical trials monitoring skills; Remote and on-site
- Demonstrated understanding of or ability to learn the company's SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
- Demonstrated ability to evaluate medical research data
- Strong organizational and negotiation skills
- Strong attention to detail
- Advanced written and oral communication skills
- Good knowledge of English language and grammar
- Demonstrated use of computer to include data entry, archival and retrieval
- Excellent teammate with team building skills
- Excellent interpersonal and conflict resolution skills
- Advanced ability to utilize problem-solving techniques applicable to constantly changing environment
- Solid knowledge of medical/therapeutic areas and medical terminology
Location
- Office
Work Type
- Standard (Mon-Fri)
Experience Level
- 5+ years
- 1+ year of leadership responsibility
About the Company
- Successfully supported the top 50 pharmaceutical companies and more than 750 biotech's, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
- When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence.
- You'll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
- Apply today to help us deliver tomorrow's breakthroughs.