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Clinical Trial Operations Manager
2 maanden geleden
We are seeking a highly skilled Clinical Trial Operations Manager to join our team at NLF Fortrea Netherlands BV. As a key member of our operations team, you will be responsible for overseeing the execution and oversight of local operational clinical trial activities.
Key Responsibilities- Accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight, and impact on local regulatory and financial compliance.
- Responsible for managing country deliverables, timelines, and results for assigned protocols to meet country commitments.
- Contributes to the development of local SOPs and oversees contract workers and local vendors as applicable.
- Works in close collaboration with internal stakeholders, including Clinical country operations, Country Quality Manager, Finance, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Business Compliance, Legal, and regional operations.
- Collaborates closely with Regional Operations to align country timelines for assigned protocols and provides support and oversight to local vendors as applicable.
- Oversight and coordination of local processes & SOPs, including clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
- In lieu of the above requirement, candidates with a minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
- Thorough understanding of the drug development process.
- Fluent in local office language and in English, both written and verbal.
- Good organizational and time management skills.
- Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
- Excellent communication skills, oral and written.
- Self-motivation with the ability to work under pressure to meet deadlines. Works well independently and in a team environment.
- Detail and process oriented.
- Positive attitude and approach.
- Interact with internal and external customers with a high degree of professionalism and discretion.
- Multi-tasking capability.
- Good computer skills with good working knowledge of a range of computer packages.
- Ability to lead and develop junior staff.
- Problem solving and Process Improvement is essential to this position.
- Minimum of eight (8) years of clinical research experience.
