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Clinical Operations Manager
2 months ago
Job Summary:
We are seeking an experienced Associate Manager/ Manager/Sr Manager Clinical Operations to join our team in Canada. The successful candidate will be responsible for managing a team of clinical operations staff, providing coaching and mentorship, and ensuring the delivery of high-quality clinical trials.
Key Responsibilities:
- Manage a team of clinical operations staff, providing coaching and mentorship to ensure the delivery of high-quality clinical trials.
- Conduct regular performance appraisals and career discussions with staff.
- Facilitate employee career development, including interviews, recruitment, and selection.
- 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.
- Support allocation activities per the local resourcing process.
- Deliver training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs).
- Identify training gaps and ensure that training requirements are met.
- Assure adherence to good ethical and regulatory standards.
- Alert management to quality issues and request QA audits as appropriate.
- Manage and review systems to evaluate employee and project metrics, KPIs, and general project status.
- Evaluate work of staff, including conducting MAs (either remote or on-site).
- 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 where required.
- Assist senior management in budgeting activity of assigned group(s) and support annual and long-range forecasting.
Requirements:
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
- Excellent mentoring/leadership/supervisory skills.
- Excellent clinical trials monitoring skills; Remote and on-site.
- Advanced knowledge of clinical trials monitoring; Remote and on-site.
- Advanced 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.
- Advanced organizational and negotiation skills.
- Strong attention to detail.
- Excellent written and oral communication skills.
- Good knowledge of English language and grammar.
- Advanced use of computer to include data entry, archival, and retrieval.
- Ability to travel as needed - approximately 25%.
- Excellent team player with team building skills.
- Excellent interpersonal and conflict resolution skills.
- Excellent ability to utilize problem-solving techniques applicable to constantly changing environment.
- Advanced knowledge of medical/therapeutic areas and medical terminology.
What We Offer:
At Thermo Fisher Scientific Inc., we offer a competitive salary, an extensive benefits package, and a flexible working culture that values work-life balance. We are a global organization with a local feel, and we are committed to enabling our customers to make the world healthier, cleaner, and safer. We are a team of 100,000+ colleagues who share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.
