Clinical Research Manager

hace 3 semanas

Bogota, 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, policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Reviews Monitoring Visits Reports and escalates performance issues and training 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
- 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 Research Labs (MRL), Global Clinical Development (GCD) and GCTO.
- Ability to identify problems, conflicts and opportunities early and lead, analyze 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

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