Requisition ID: CLI008276
MSD 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 MSD has codified its 125:year legacy. MSD's 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 with ICH/GCP and country regulations, Merck 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, Merck 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
: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 countriesclustersQualifications
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
: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.
: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 effectiv
