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About the Role

As a Manager, Clinical Operations in FSP, you will oversee, train, resource, coach and performance manage a team, focusing on end results using metrics and key performance indicators. You will act as point-of-escalation regarding performance concerns and training needs, and collaborate with the leadership team for resourcing needs.

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.
• 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.

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.

Skills

• 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

Location

• Office

Work Type

• Standard (Mon-Fri)

Experience Level

• 5+ years
• 1+ year of leadership responsibility

About the Company

• 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.
• As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers.
• Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer.
• Their work is a story of purpose.
• Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion.
• Our Mission is to enable our customers to make the world healthier, cleaner and safer.
• Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them.
• Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Equal Opportunity

• We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
• Please contact us to request accommodation.
• Thermo Fisher Scientific is an Equal Opportunity Employer.
• All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.