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Clinical Research Manager

hace 2 meses

Bogotá, 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.

The CRM could be responsible for a particular study for several countries in a cluster.

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 Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Project Temps (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

09/13/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Job Posting End Date:09/13/2024


A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Requisition ID:R302330