Manager, Clinical Operations – FSP
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Job Description
Manager, Clinical Operations leading clinical teams and ensuring adherence to protocols for global clinical trials. Collaborating with leadership to optimize project performance and compliance.
Responsibilities:
- Manages 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
- Manages 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 leads/functional leads to optimize the operational running of projects
- Raises appropriately any issues which may impact project deliverables
- 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 contribute to development of training programs, where appropriate
- Assures adherence to good ethical and regulatory standards
- Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required
- Handles and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs 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 contribute to the procurement of new business where required
- Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required
- May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company
Requirements:
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
- 1+ year of leadership responsibility
- 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
Benefits:
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
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