Manager Clin Ops Management - FSP
Thermo Fisher Scientific
- France
- CDI
- Temps-plein
- Leads staff, providing coaching, mentorship and work direction
- Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews, recruits and selects staff
- Leads and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company
- Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. Ensures timeliness and accuracy of timesheets and expense reports
- Supports allocation activities per the local resourcing process. Supports activities of project managers and clinical team managers to optimize the operational running of projects.
- Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. Identifies training gaps and ensures that training requirements are met. May help with development of training programs, where appropriate
- Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required
- Leads and reviews systems (e.g. CTMS, Preclarus, Clarity) to evaluate employee and project metrics, performance and general project status.
- Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.
- Participates in process improvement/development initiatives.
- Ensures understanding and facilitation of the risk based monitoring approach.
- May provide input into bids and assist in the procurement of new business where required.
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor)
- Excellent mentoring/leadership/supervisory skills
- Knowledge of clinical trials monitoring; Remote and on-site
- Validated understanding of or ability to learn PPD SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
- Validated ability to evaluate medical research data
- Strong organizational and negotiation skills
- Strong attention to detail
- Effective written and oral communication skills
- Good knowledge of English language and grammar
- Competent use of computer to include data entry, archival and retrieval
- Ability to travel as needed
- Excellent interpersonal and conflict resolution skills
- Ability to use problem-solving techniques applicable to constantly changing environment
- Proven knowledge of medical/therapeutic areas and medical terminology