Thermo Fisher Scientific logo
Thermo Fisher Scientific

The World Leader In Serving Science

Clinical Operation Manager, FSP

ManagerManagerFull TimeRemoteSeniorTeam 10,001+Since 1956H1B SponsorCompany SiteLinkedIn

Location

Spain

Posted

3 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expExperience acceptedEnglishGoogle Cloud Platform

Job Description

Clinical Operation Manager, FSP

Thermo Fisher Scientific

• 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.

Job Requirements

  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
  • 1+ year of leadership responsibility.
  • 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.

Benefits

  • Health insurance
  • Professional development opportunities

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