MSD Clinical Research Manager CRM 

Colombia 

940102868

Job Description

This role is primarily accountable for the end-to-end performance and project management for

requirements internally and externally.

Responsibilities include, but are not limited to:

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
• Responsible for project management of the assigned studies: pro-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.
• Accountable for performance 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.
• Reviews Monitoring Visits Reports and escalates performance issues and trainings needs to CRA manager and/or functional vendor and internal management as needed.
• Performs Quality control visits as required.
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs and COM).
• Responsible for creating and executing a local risk management plan for assigned studies. Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
• Escalates as needed different challenges and issues to TA Head/CRD/CCQM and or CTT (as appropriate).
• Identifies and shares best practices across clinical trials, countries, clusters.
• Responsible for collaboration 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.
• Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).
• Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD, TAH and Regional Operations.
• Collaborates 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. Examples of common problems include: 1) low patient recruitment 2) inadequate staff to meet business needs 3) performance or compliance issues 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations.
• Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.

• Experience Requirements :

  Required:

  • 5-6 years of experience in clinical research

  • CRA Experience preferred

  Educational Requirements:

  Required:

  • Bachelor degree in Science (or comparable)

  Preferred:

  • Advanced degree, (e.g., Master degree, MD, PhD)

Current Contingent Workers apply

No Travel Required

Not ApplicableNot Indicated

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