Assoc. Manager / Manager, Clinical Operations - FSP
About The Position
The FSP Manager, Clinical Operations oversees, trains, resources, coaches, and performance-manages a team that may include various clinical operations staff. The role focuses on results through metrics and key performance indicators, serves as an escalation point for performance concerns and training needs, and helps ensure adherence to company SOPs and WPDs. The manager collaborates with leadership on resourcing needs and is dedicated to one sponsor in the FSP environment. The position manages staff and supports their development, onboarding, training, and performance. It supports resource allocation and project operations, monitors employee and project metrics and status, promotes ethical and regulatory compliance, and addresses quality and risk-based monitoring practices. The manager may also contribute to process improvement, business development, bids, procurement, and strategic planning.
Requirements
- Bachelor's degree or equivalent and relevant formal academic or vocational qualifications.
- Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 0–5 years.
- At least 1 year of leadership responsibility.
- Advanced mentoring, leadership, and supervisory skills.
- Excellent clinical trial monitoring skills, both remote and on-site.
- Understanding of, or ability to learn, company SOPs, WPDs, and relevant regulations such as ICH/GCP and FDA guidelines.
- 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.
- Ability to use computers for data entry, archival, and retrieval.
- Ability to travel as needed.
- Teamwork and team-building skills.
- Interpersonal and conflict-resolution skills.
- Ability to apply problem-solving techniques in a constantly changing environment.
- Knowledge of medical and therapeutic areas and medical terminology.
- An equivalent combination of appropriate education, training, and/or directly related experience may be considered sufficient in some cases.
Responsibilities
- Manage staff and provide coaching, mentorship, and work direction.
- Conduct performance appraisals and career discussions; facilitate career development; interview, recruit, and select staff.
- Manage and conduct induction and orientation programs for new employees.
- Ensure staff CVs, training records, position profiles, and experience profiles are complete and current; ensure timesheets and expense reports are timely and accurate.
- Support resource allocation and project leads or functional leads in optimizing project operations; raise issues that may affect project deliverables.
- Deliver training on WPDs, SOPs, local requirements, and other clinical operations topics; identify training gaps and ensure training requirements are met.
- Ensure adherence to ethical and regulatory standards.
- Alert management to quality issues, request QA audits when appropriate, and facilitate client and internal quality assurance audits.
- Review systems such as Activate, CTMS, Preclarus, and Clarity to evaluate employee and project metrics, KPIs, and project status.
- Evaluate staff work, including conducting remote or on-site PAVs to assess monitoring skills and project conduct when applicable.
- Participate in process improvement and development initiatives.
- Ensure understanding and facilitation of the risk-based monitoring approach.
- Provide input into bids and contribute to procurement of new business when required.
- Collaborate with clinical operations senior management and executive staff on strategic planning and business development as required.
- Lead or contribute to initiatives that enhance departmental performance or improve processes across the company.
Benefits
- 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 of paid time off and 10 paid holidays annually.
- Paid parental leave, including 3 weeks for bonding and 8 weeks for caregiver leave.
- Accident and life insurance.
- Short- and long-term disability in accordance with company policy.
- 401(k) retirement savings plan.
- Employees’ Stock Purchase Plan offering eligible colleagues the opportunity to purchase company stock at a discount.
- Potential eligibility for a variable annual bonus based on company, team, and/or individual performance results.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
