Clinical Research Director

hace 5 horas

Ciudad de México, Ciudad de México MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completo

Job Summary

MEX Labcorp Clinical Development, S. de R.L. de C.V. is seeking a highly skilled Clinical Research Manager to lead clinical trials and drive business growth. As a key member of our clinical operations team, you will be responsible for project management, protocol execution, and ensuring compliance with regulatory requirements.

Key Responsibilities:

  1. Main point of contact for assigned protocols and link between Country Operations and clinical trial team.
  2. Responsible for project management of assigned studies: actively plans, drives, and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution, and close-out.
  3. Reviews Monitoring Visits Reports and raises performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
  4. Performs Quality control visits as required.
  5. Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol guide and coordinates activities across the different local country roles ensuring a strong collaboration.
  6. Responsible for crafting and executing a local risk management plan for assigned studies.
  7. Ensures compliance with CTMS, eTMF, and other key systems.
  8. Raises as needed different challenges and issues.
  9. Responsible for collaboration with functional outsourcing vendors, investigators, other external partners.
  10. Country point of contact for programmatically outsourced trials.
  11. Serves local business needs as applicable in his/her country (If delegated can sign contracts and run budgets).
  12. Collaborates internally with HQ functions and locally with PV, Regulatory, and GMA to align on key decisions in his/her studies.
  13. As a customer-facing role, this position will build business relationships and represent the company with investigators.
  14. Shares protocol-specific information and standard methodologies across countries/clusters.

Requirements:

  1. 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.
  2. Previous experience in clinical research in pharmaceutical or CRO industries.
  3. Previous experience in managing trials.
  4. Deep understanding of local regulatory environment.
  5. 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.
  6. Ability and skills to lead resource allocation, processes (and controls), productivity, quality, and project delivery.
  7. Strong organizational skills and time management skills.
  8. Excellent interpersonal skills.
  9. Proficiency in written and spoken English.

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