Manager, Clin Ops - FSP

Thermo Fisher Scientific • Wilmington, NC

1d • Onsite

About The Position

Join Us as Manager, Clinical Operations in FSP – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotech's, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As a Manager, Clinical Operations in FSP, 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.

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.
• 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

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed