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Thermo Fisher Scientific

Manager / Sr. Manager, Clinical Operations - FSP West Region

RemoteUnited States only
Published
Role
Operations
Experience
Senior
Employment
Full-time
Company size
Enterprise
$115k–$178k/yr
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Open to US only. Set where you work from to check your eligibility.

No BS summary

Clinical operations manager with 5+ years of relevant experience and 1+ year of leadership responsibility. Needs strong clinical trials monitoring experience, regulatory/SOP knowledge, English, and ability to travel. Remote role with strong preference for West Coast candidates.

Required languages

English Good knowledge of English language and grammar; required=true

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.

What they require

  • 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.
  • Team has a strong preference for candidates on the West Coast
  • 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

Benefits

  • Variable annual bonus based on company, team, and/or individual performance results in accordance with company policy
  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs
  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement
  • At least 120 hours paid time off (PTO)
  • 10 paid holidays annually
  • Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
  • Accident and life insurance
  • Short- and long-term disability in accordance with company policy
  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
  • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

multinational company providing scientific instrumentation

Life SciencesEnterprisethermofisher.com/

What people say about this company

3.4/ 5

$115k–$178k/yr