Primary care physician Work, Jobs in Hook, Ham (with Salaries)

Post-Trial Access Manager, Continued Access - Sponsor Dedicated
IQVIA —Reading
- Full-time
- Remote
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- Bachelor's degree
- No degree
- Employee assistance programme
Patients Services Call Handler
FRMG —Slough
- £12.75 an hour
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- Front desk
- Free parking
- Health & wellbeing programme
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Experience Patient Services Receptionist Administrator
Farnham Road Practice —Slough
- From £13.50 an hour
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- Administrative experience
- Travel
- Free parking
- Store discount
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Post-Trial Access Manager, Continued Access - Sponsor Dedicated

IQVIA -
Reading

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Job details

Full-time

Benefits

Employee assistance programme

Qualifications

Clinical research
Project management
Bachelor's degree

Full job description

Reading, United Kingdom | Full time | Home-based | R1546701

Post-Trial Access Manager, Continued Access is accountable for the execution of multiple global PTA programs, of mild and moderate complexity, with minimal supervision.

PTA here refers to the provision of investigational product for the intent of treatment, in a non-trial setting and under the care of a physician, following participation in a trial. PTA by this definition is governed by local laws and regulations and may be provided by established regulatory mechanisms such as early access, named patient programs, and other pre-approval access and managed access programs.

Responsabilities

Develop and manage timelines and budgets for post-trial access (PTA) programs supporting investigational products prior to regulatory approval
Ensure compliance with regulatory requirements and company Policies/SOPs
Lead cross-functional teams and serve as primary program contact for PTA/Continued Access programs
Populate PTA templates and tools with program-specific information related to investigational product access decisions and implementation
Drive development and finalization of core program documents (e.g. PTA Treatment Guidelines, PTA ICF, agreements and contracts)
Drive decision-making, including selection of appropriate regulatory mechanisms, supply strategy, and safety reporting, in collaboration with cross-functional stakeholders; with support as needed
Ensure alignment across PTA program decisions, documentation, plans, and implementation
Provide forecasting and ensure investigational supply strategies are developed and executed, in collaboration with Supply Chain, to facilitate uninterrupted patient access to investigational products
Manage requests for investigational product access through PTA programs, ensuring timely and compliant processing
Manage vendor contracting and deliverables in support of PTA/continued access program execution
Utilize PTA tools, templates, and systems to ensure accurate tracking and reporting of investigational access programs
Monitor quality, KPIs, and program performance; identify issues and escalate as needed
Communicate PTA program status, risks, and updates to stakeholders
Identify risks and implement mitigation strategies specific to investigational product access and program continuity; capture lessons learned and best practices
Ensure inspection readiness, maintain complete and accurate documentation, and perform quality checks for PTA programs
Support other PTA/continued access activities and programs, as assigned

Requirements

BS/BA (or equivalent experience)
Experience in clinical research or biopharmaceutical operations; including 2+ years leading global, multi-regional PTA programs across the lifecycle, for investigational products prior to regulatory approval; 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 effectively; influencing stakeholders across functions and levels
Evidence of strong project management skills; including managing competing priorities and solving operational challenges in clinical or investigational program environments
Successful history of working independently in a global environment
Experience with automating processes, process mapping and/or certification in Lean or Six Sigma would be considered an advantage, though it is not a mandatory requirement.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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