Clinical Operations Management Lead

4 tygodni temu

Warszawa, Mazovia, Polska Thermo Fisher Scientific Pełny etat

At Thermo Fisher Scientific, we are seeking a highly skilled Clinical Operations Management professional to join our team. As a Clinical Operations Management Lead, you will be responsible for managing a team of experienced professionals and subordinate management who exercise latitude and independence in their assignments.

Key Responsibilities:

  • Performance management, providing coaching, mentorship and work direction.
  • Support change management, conduct regular performance appraisals and career discussions with staff.
  • Facilitate employee career development, interviews, recruits and selects staff.
  • Manage and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company.
  • Ensure all staff CVs, training records, position profiles and experience profiles are complete and up-to-date.
  • Support 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 (Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.
  • Evaluates work of staff, including conducting performance assessment visits (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.

Requirements:

  • 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.

Preferred Qualifications:

  • 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 (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 team player 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.

What We Offer:

At Thermo Fisher Scientific, we offer a competitive salary, an extensive benefits package based around the health and well-being of our employees, and a collaborative environment with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. We value a work-life balance and offer opportunities for growth and development.

Our 4i Values:

Integrity – Innovation – Intensity – Involvement

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