Assoc. Manager / Manager, Clinical Operations - FSP

Thermo Fisher Scientific • Carlsbad, CA

8d • Onsite

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 measured through metrics and key performance indicators, serves as an escalation point for performance concerns and training needs, and ensures adherence to company Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs). The manager collaborates with leadership on resourcing and is dedicated to one sponsor in the FSP environment.

The position includes staff leadership and development, recruiting and onboarding, maintaining employee records, supporting project and resource allocation, delivering training, and promoting ethical, regulatory, and quality standards. It also involves reviewing systems and project metrics, assessing staff work and monitoring skills, supporting risk-based monitoring, and contributing to process improvement and business development initiatives.

The position follows a standard Monday–Friday schedule in an office environment. Travel may be required as needed.

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, including 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.
• Experience using computers for data entry, archiving, and retrieval.
• Ability to travel as needed.
• Teamwork and team-building skills.
• Interpersonal and conflict-resolution skills.
• Advanced problem-solving skills for a constantly changing environment.
• Solid knowledge of medical or therapeutic areas and medical terminology.

Nice To Haves

• An equivalent combination of appropriate education, training, and/or directly related experience may be considered sufficient to meet the role requirements.

Responsibilities

• Manage staff, providing coaching, mentorship, and work direction.
• Conduct regular performance appraisals and career discussions, and facilitate employee 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 up to date; ensure timesheets and expense reports are timely and accurate.
• Support allocation activities under the local resourcing process and assist project and 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 requirements are met.
• Assure adherence to good ethical and regulatory standards.
• Alert management to quality issues, request QA audits when appropriate, and facilitate client and internal quality assurance audits as required.
• 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 department 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 (PTO) and 10 paid holidays annually.
• Paid parental leave, including 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.
• Competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan offering eligible colleagues the opportunity to purchase company stock at a discount.
• May be eligible for a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager