IQVIA

Description of Roles and Responsibilities

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, Sponsor's policies and procedures, quality standards and adverse event reporting requirements internally and externally. 

For certain studies, the CPM could be responsible 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, Sponsor's policies and procedures, quality standards and adverse event reporting requirements internally and externally. 

o 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 for other local roles, collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTA, CRAs, and RSUM) 
• 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) 
• 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 Sponsor 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. 
• Lead and contribute to initiatives and projects adding value to the business and supporting the strategy 

Experience Required

• 2+ years of experience as local Clinical Project Manager or Lead CRA
• CRA experience preferred. 

Educational Requirements

Required: 

• Bachelor’s degree in science (or comparable) 

Preferred: 

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

Competency Expectations 

Knowledge in Project Management and site management.

• Strong organizational skills and Strategic thinking
• Requires ability to make decisions independently and oversee important activities 
• 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. 
• Ability to work efficiently in a remote and virtual environment
• The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring.

Strong leadership 

• Ability to identify problems, conflicts and opportunities 
• Negotiate skillfully in tough situations with both internal and external groups

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com