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Clinical Research Operations Manager
2 meses atrás
Fortrea is seeking an experienced Clinical Research Operations Manager to join our team. As a key member of our clinical research operations team, you will be responsible for the execution and oversight of local operational clinical trial activities.
Key Responsibilities- Oversee local regulatory and financial compliance at a country operations level, ensuring adherence to ICH GCP and country regulations.
- Develop and implement country-specific trial commitments and objectives, ensuring effective conduct of clinical studies and maintenance of local regulatory and compliance requirements.
- Build and maintain business relationships with investigators, functional outsourcing partners, and other external partners, representing Fortrea with a high degree of professionalism and discretion.
- Make decisions independently and oversee important activities relevant to clinical research activities in the country, with the support of the Country Research Director or Therapeutic Director.
- Collaborate with Country and Regional Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, and Global Human Health teams, as well as external functional outsourcing vendors, to ensure alignment and coordination.
- University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution.
- Strong clinical research experience, with a working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC, and other applicable regulations/guidelines.
- Excellent communication skills, both oral and written, with the ability to work independently and as part of a team.
- Self-motivation, with the ability to work under pressure to meet deadlines, and a positive attitude and approach.
- Good computer skills, with a working knowledge of a range of computer packages, and the ability to lead and develop junior staff.
