Clinical Research Manager

6 days ago


Petaling Jaya, Malaysia IQVIA Full time

**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 training needs to CRA manager and/or functional vendor and internal management as needed. o
- 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 sponsor with investigators
- Shares protocol-specific information and best practices across countries\clusters

**Requirements**:

- Bachelor’s degree in science relevant studies
- Possesses 5-6 years of experience in clinical research
- Knowledge in Project Management and site management.
- Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.;
- Strong written and verbal communication skills including good command of English language. Strong presentation skills.
- Strong problem solving skills.



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