Clinical Research Manager
MSD
Vincente Lopez, Munro, Argentina
hace 4 días

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 125-year legacy.

Our company success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

This role is primarily accountable for the end to end performance for assigned protocols in a country in compliance and regulations, our 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.

Reviews Monitoring Visits Reports and escalates performance issues and training needs. - Performs Quality control visits as required

Leads local study teams to high performance : trains in the protocol other local roles, closely collaborates as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration

Responsible for creating and executing a local risk management plan for assigned studies

Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies

Country POC for programmatically outsourced trials for assigned protocols.

Serves local business needs as applicable in his / her country(If delegated can sign contracts and manage budgets)

Collaborates internally with HQ functions and locally with pharmacovigilance and to align on key decisions in his / her studies.

As a customer-facing role, this position will build business relationships and represent our company with investigators

Shares protocol-specific information and best practices across countries clusters

CORE Competency Expectations :

Knowledge in Project / 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

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.

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

Behavioural Competency Expectations :

Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our company Research Labs, Global Clinical Development and our Research & Development division.

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 external stakeholders

Experience Requirements :

Required :

5-6 years of experience in clinical research of which 3 as monitor

Educational Requirements :

Required :

Bachelor degree in Science (or comparable)

Preferred :

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

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