IQVIA
PostTrialAccessManager,ContinuedAccess
“Post-Trial Access Manager, Continued Access at IQVIA. Develop and manage timelines and budgets for post-trial access (PTA) programs. Ensure compliance with regulatory requirements and company Policies/SOPs”
What You'll Achieve.
Ensure compliance; Facilitate uninterrupted patient access; Ensure timely and compliant processing; Accurate tracking and reporting; Monitor quality; Identify issues and escalate; Implement mitigation strategies; Ensure inspection readiness; Perform quality checks
Industry & Context.
Solving operational challenges
What They're Looking For.
Must Have
BSA (or equivalent experience), Experience in clinical research or biopharmaceutical including 2+ years leading global, multi-regional PTA programs across the lifecycle, for investigational products prior to regulatory comparable experience leading expanded access/compassionate use programs or significant experience contributing to PTA or EAP may be considered, Experience managing Oncology Global trials, General understanding of regulatory frameworks governing pre-approval and continued access to investigational products, ICH GCP, and ethical frameworks of clinical research, Demonstrated ability to manage mild to moderately complex, multi-region PTA programs involving investigational products with a degree of operational and regulatory complexity, with minimal supervision, Proven experience collaborating influencing stakeholders across functions and levels, Evidence of project management including managing competing priorities and solving operational challenges in clinical or investigational program environments, Successful history of working independently in a global environment
Nice to Have
Experience with automating processes, process mapping and/or certification in Lean or Six Sigma would be considered an advantage
What You'll Do.
Develop and manage timelines and budgets for post-trial access (PTA) programs
Ensure compliance with regulatory requirements and company Policies/SOPs
Lead cross-functional teams and serve as primary program contact
Populate PTA templates and tools with program-specific information
Drive development and finalization of core program documents
Drive decision-making
including selection of appropriate regulatory mechanisms
Ensure alignment across PTA program decisions
Provide forecasting and ensure investigational supply strategies are developed and executed
Manage requests for investigational product access through PTA programs
Manage vendor contracting and deliverables in support of PTA/continued access program execution
and systems for tracking and reporting
and program identify issues and escalate
Communicate PTA program status
and updates to stakeholders
Identify risks and implement mitigation strategies
Ensure inspection readiness
maintain complete and accurate documentation
Support other PTA/continued access activities and programs
How You'll Work.
Team & Collaboration
Lead cross-functional teams; Collaborating influencing stakeholders across functions and levels; Collaboration with Supply Chain
Communication Scope
Communicate PTA program status, risks, and updates to stakeholders
Process & Methodology
Manage timelines, Manage budgets, Manage competing priorities, Solving operational challenges
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