Clinical Research Manager

hace 3 semanas

Xico, México Fortrea A tiempo completo
Job Title: Clinical Research Manager

Fortrea is seeking a highly skilled Clinical Research Manager to join our team. As a Clinical Research Manager, you will be responsible for managing clinical trials from start to finish, ensuring that all studies are conducted in accordance with regulatory requirements and company standards.

Key Responsibilities:
  • Manage clinical trials from feasibility to close-out, ensuring timely and within-budget completion.
  • Develop and implement project plans, timelines, and budgets for clinical trials.
  • Collaborate with cross-functional teams, including clinical operations, regulatory, and quality assurance, to ensure seamless execution of clinical trials.
  • Ensure compliance with regulatory requirements, company policies, and industry standards.
  • Lead local study teams to high performance, training local roles, and closely collaborating with CRAs.
  • Responsible for crafting and executing a local risk management plan for assigned studies.
  • Ensure compliance with CTMS, eTMF, and other key systems.
  • Raises as needed different challenges and issues.
  • Collaborate internally with HQ functions and locally with PV, Regulatory, and GMA to align on key decisions in his/her studies.
Requirements:
  • University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
  • Previous experience in clinical research in pharmaceutical or CRO industries.
  • Previous experience in managing trials.
  • Deep understanding of local regulatory environment.
  • Strong understanding of clinical trial planning, management, and metrics is important as well as the ability to focus on multiple deliverables and protocols at a time.
  • Ability and skills to lead resource allocation, processes (and controls), productivity, quality, and project delivery.
  • Strong organizational skills and time management skills.
  • Excellent interpersonal skills.
  • Proficiency in written and spoken English.

Fortrea is an Equal Opportunity Employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity, equity, and inclusion.

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