This role is primarily accountable for the end to end performance for assigned protocols in a country in compliance with ICH / GCP and country regulations, and procedures, quality standards and adverse event reporting requirements internally and externally.
The CRM / CTL 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, 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
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 / CQM and or CTT (as appropriate)
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 PV, Regulatory and GMA to align on key decisions in his / her studies.
GHH to be consulted as needed.
As a customer-facing role, this position will build business relationships and represent MSD with investigators
Shares protocol-specific information and best practices across countries clusters
Education / Qualifications
Bachelor degree in Science (or comparable)
Advanced degree, (e.g., Master degree, MD, PhD
Experience Requirements :
5-6 years of experience in clinical research of which 3 as CRA
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