Role at a glance
- Salary
- Not Disclosed
- Location
- 3 Locations
- Work arrangement
- Remote
- Employment
- Full-time
- Experience
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 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.
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Role Summary
The Manager Clinical Operations oversees and develops clinical operations staff, monitors performance and training, and supports project resourcing and operational delivery. The role also reviews project and employee metrics, supports quality and regulatory adherence, and contributes to process improvement and departmental initiatives.
What You'll Do
- Manage, coach, mentor, direct, and evaluate staff, including performance appraisals, career discussions, recruitment, and onboarding.
- Maintain staff records and support resource allocation, project leads, and functional leads in project operations.
- Deliver training on WPDs, SOPs, local requirements, and clinical operations topics; identify training gaps and ensure requirements are met.
- Review employee and project metrics, KPIs, and project status using operational systems; conduct staff evaluations, including remote or...
- Raise quality issues, request and facilitate audits, support ethical and regulatory adherence, and facilitate risk-based monitoring.
- Participate in process and performance improvement initiatives, and contribute to bids or strategic planning as required.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Requires previous experience comparable to 5+ years and 1+ year of leadership responsibility; in some cases, a combination of appropriate education, training and/or directly related experience may be considered sufficient. Skills include advanced mentoring and supervisory ability, clinical-trial monitoring, understanding or ability to learn SOPs, WPDs and relevant regulations such as ICH/GCP and FDA guidelines, medical research data evaluation, organizational and negotiation skills, written and oral communication, English language and grammar, computer data entry and retrieval, medical terminology, problem-solving, and interpersonal and conflict-resolution skills.
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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 a 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.
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:
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 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.
Apply today to help us deliver tomorrow’s breakthroughs
About the company
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.