Manager, Clinical Operations; FSP; Southeast Region

Work Schedule

Standard (Mon-Fri)

Office

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

• 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.
• Escalates 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.
• Manages 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.

Interprets and administers policies, processes, and procedures that may affect sections and subordinate work units. Requires full knowledge of own area of functional responsibility.

Assignments are defined in terms of activities and objectives. Work is reviewed upon completion for adequacy in meeting objectives. A portion of the time may be spent performing individual tasks.

Interacts frequently with internal personnel and outside representatives at various levels. Participates and presents at meetings with internal and external representatives. Interaction typically concerns resolution of operational and scheduling issues.

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• 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…