Clinical Research Manager

hace 1 semana

Bogotá, Bogotá D.E., Colombia MSD A tiempo completo
Job Description

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Key Responsibilities:
  • Act as the main point of contact for assigned protocols and serve as a link between Country Operations and clinical trial teams.
  • Responsible for project management of assigned studies, including planning, driving, and tracking execution and performance of deliverables/timelines/results to meet country commitments.
  • Accountable for performance of assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
  • Review Monitoring Visits Reports and escalate performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
  • Perform Quality control visits as required.
  • Lead local study teams to high performance, training in the protocol other local roles, closely collaborating with and supporting CRAs as protocol expert and coordinating activities across the different local country roles ensuring a strong collaboration.
  • Responsible for creating and executing a local risk management plan for assigned studies, ensuring compliance with CTMS, eTMF and other key systems in assigned studies.
  • Escalate as needed different challenges and issues to TA Head/CRD/CCQM and/or CTT (as appropriate).
  • Identify and share best practices across clinical trials, countries, clusters.
  • Collaborate with functional outsourcing vendors, investigators, other external partners in assigned studies.
  • Country POC for programmatically outsourced trials for assigned protocols.
  • As a customer-facing role, this position will build business relationships and represent the Company with investigators.
  • Serve local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).
  • Support local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TAH and Regional Operations.
  • Collaborate internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials. Consult with GHH as needed.
Core Competency Expectations:
  • Knowledge in Project Management and site management.
  • Strong organizational skills with demonstrated success required.
  • Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CRD.
  • Requires strong understanding of local regulatory environment.
  • Strong scientific and clinical research knowledge is required.
  • Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
  • Experience functioning as a key link between Country Operations and Clinical Trial Teams.
  • Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.
  • Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery.
  • Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
  • Strategic thinking.
  • Ability to work efficiently in a remote and virtual environment.
  • Understand cultural diversity.
  • The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring.
Behavioural Competency Expectations:
  • Strong leadership skills that enable and drive alignment with the goals, purpose and mission of Company Research Labs, Global Clinical Development (GCD) and GCTO.
  • Ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical.
  • Required to negotiate skilfully in tough situations with both internal and external groups; settle differences with minimum disruption.
  • Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.
Experience Requirements:
  • 5-6 years of experience in clinical research.
  • CRA Experience preferred.
Education Requirements:
  • Bachelor degree in Science (or comparable).
Preferred Education:
  • Advanced degree, (e.g., Master degree, MD, PhD).

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