Manager Clinical Operations Management, Warsaw

4 tygodni temu

Warszawa, Mazovia, Polska TN Poland Pełny etat
Job Title:

Manager Clinical Operations Management, Warsaw

Description:

At PPD, we are passionate about improving health. We provide comprehensive drug development services that connect innovative ideas with the people who need them.

Our clinical department defines and delivers clinical programs, ensuring high-quality data review and effective interaction with study sites. We identify and treat clinical trial participants while providing needed care.

Key Responsibilities:

  • Manage a team of clinical operations staff, including CAS, CS, CRAs, ACRAs, CTC, and other focused staff.
  • Use metrics and KPIs to measure performance and drive end results.
  • Lead initiatives to enhance departmental performance or implement process improvements across the company.
  • Collaborate with senior management on strategic planning and business development.
  • Act as point-of-escalation for performance concerns and training needs, ensuring adherence to SOPs and WPDs.

Essential Functions:

  • Performance management, coaching, mentorship, and work direction.
  • Support change management.
  • Conduct regular performance appraisals and career discussions with staff.
  • Facilitate employee career development, interviewing, recruiting, and selecting staff.
  • Manage induction/orientation programs for new employees.
  • Ensure staff CVs, training records, position profiles, and experience profiles are complete and up-to-date.
  • Support project leads/functional leads to optimize project operations.
  • Escalate issues impacting project deliverables.
  • Deliver training on WPDs, SOPs, local requirements, and other subjects affecting clinical operations.
  • Identify training gaps and ensure training requirements are met.
  • Contribute to training program development where appropriate.
  • Assure adherence to good ethical and regulatory standards.
  • Alert management to quality issues and request QA audits as necessary.
  • Manage and review systems (Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs, and general project status.
  • Evaluate staff work, including performance assessment visits.
  • Participate in process improvement/development initiatives.
  • Ensure understanding and facilitation of risk-based monitoring approaches.
  • Provide input into bids and contribute to procurement of new business where required.

Qualifications:

Education and Experience:

  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
  • Previous experience providing knowledge, skills, and abilities comparable to 5+ years.
  • 1+ year of leadership responsibility.

Knowledge, Skills and Abilities:

  • Advanced mentoring/leadership/supervisory skills.
  • Excellent clinical trials monitoring skills; remote and on-site.
  • Demonstrated understanding of or ability to learn company 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 environments.
  • Solid knowledge of medical/therapeutic areas and medical terminology.

What We Offer:

At PPD clinical research services, we hire the best, develop ourselves and each other, and recognize the power of being one team. We value a work-life balance and offer an extensive benefits package based around employee health and well-being. We're a global organization but have a local feel.

4i Values:

Integrity – Innovation – Intensity – Involvement

If you resonate with our 4i values and want to accelerate the delivery of safe and effective therapeutics for urgent health needs, submit your application.

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