Associate Manager / Manager, Clinical Operations - FSP

Regulatory Toolkit; California; On-site; USD 115,000 - 180,000; Full time

Benefits offered by this job

Total Rewards package

PTO 120 hours/year

401(k) plan

Job summary

Thermo Fisher Scientific is seeking a Manager Clinical Operations in California to oversee a dedicated team within the FSP environment. You will coach, train and resource staff, ensuring timely delivery and adherence to SOPs and WPDs across multiple projects.

You will drive performance with KPIs, conduct appraisals, and partner with leadership for resourcing and strategic planning. This role blends people leadership with operational excellence.

Qualifications

• Bachelor’s degree or equivalent and relevant formal qualifications.
• 0 to 5 years of experience in similar roles.
• 1+ year of leadership responsibility.
• Equivalency (education/training/experience) may be considered.

Responsibilities

• Manages staff, providing coaching, mentorship and work direction.
• Conducts regular performance appraisals and career discussions with staff.
• Interviews, recruits and selects staff.
• Manages induction/orientation programs for new employees.
• Ensures CVs, training records and profiles are current; manages timesheets and expenses.
• Supports allocation activities and project leadership to optimize operations.
• Delivers training on WPDs and SOPs; identifies training gaps and develops programs.
• Ensures adherence to ethical and regulatory standards.
• Alerts management to quality issues and facilitates QA/audits.
• Reviews systems to evaluate metrics and project status.
• Evaluates staff work via PAVs (remote or on-site).
• Participates in process improvement and risk-based monitoring initiatives.
• Contributes to bids and procurement when needed.
• Collaborates with senior management on strategic planning and business development.

Skills

Leadership

Clinical monitoring

Regulatory knowledge

Communication

Travel readiness

Education

Bachelor’s degree or equivalent

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as Manager Clinical Operations – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As an FSP Manager Clinical Operations, you will oversee, train, resource, coach and performance manage a team, which may be inclusive of various clinical operations focused staff. You will focus on end results using metrics and key performance indicators to lead performance. You will act as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs. You will also work in collaboration with the leadership team for resourcing needs. In this role, you will be dedicated to one sponsor in our FSP environment.

What You’ll Do:

• 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.

Education and Experience Requirements

• Bachelor’s degree or equivalent and relevant formal academic / vocational qualifications
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 5 years).
• 1+ year of leadership responsibility
• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities

• 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
• Demonstrated use of computer to include data entry, archival and retrieval
• Ability to travel as needed
• Excellent teammate with team building skills
• Excellent interpersonal and conflict resolution skills
• Advanced ability to utilize problem-solving techniques applicable to constantly changing environment
• Solid knowledge of medical/therapeutic areas and medical terminology

Why Join Us

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Compensation and Benefits

The salary range estimated for this position based in California is $115,000.00–$180,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• 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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards