Certification manager Work, Jobs in Datchet, Brk (with Salaries)

Post-Trial Access Manager, Continued Access - Sponsor Dedicated
IQVIA —Reading
- Full-time
- Remote
- Project management
- Bachelor's degree
- No degree
- Employee assistance programme
9d
Master - London
Svitzer —London
- £70,722.46 a year
- Full-time
- Master's degree
- Administrative experience
- Communication skills
- Employee assistance programme
Health & Safety Manager – Luxury Estate & Hospitality Operations
Splendid Works —Windsor
- £40,000 - £60,000 a year
- Full-time
- Hospitality
- Management
- English
Quick apply
7d
Building Manager
Sky Happiness Property Management (UK) Company Limited —London
- £50,000 - £70,000 a year
- Full-time
- Management
- Maintenance
- English
- Free parking
Quick apply
Fitness & Wellbeing Manager
Castle Royle Golf and Country Club —Twyford
- £32,000 - £38,000 a year
- Weekend availability
- Bachelor's degree
- First Aid Certification
- Free parking
- Employee assistance programme
Estate Manager
MAPP —Maidenhead
- £50,000 - £55,000 a year
- Full-time
8d
Certification Project Manager
BRE —Watford
- £40,000 - £45,000 a year
- Hybrid work
- Project management
- Free parking
2d
Project Manager
Eckoh —Hemel Hempstead
- From £65,000 a year
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Microsoft Excel
- Analysis skills
- Free parking
- Work from home
Quick apply
7d
Trainee Property Manager
LRG —Reading
- Up to £28,800 a month
- Hybrid work
- Customer service
- Microsoft Office
- IT
- Employee discount
Quick apply
Certification Project Manager
BRE Group (Building Research Establishment) —Watford
- £40,000 - £45,000 a year
- Full-time
- Hybrid work
- Project management
- In-person
- Free parking
2d
Operations Manager
DoubleTree by Hilton St. Anne's Manor —Wokingham
- £48,000 a year
- Full-time
- Hotel
- Hotel experience
- Free parking
- Employee discount
Quick apply
14d
Channel Enablement & Certification Manager
Sapiens —London
- Full-time
- Travel
- Communication skills
Training and Development Coordinator
Glenholme Healthcare Ltd —Eton
- £30,000 - £35,000 a year
- Full-time
- Microsoft Office
- Presentation skills
- Driving
- Employee assistance programme
- Life insurance
Quick apply
Senior Property Manager
Property Lounge —Staines-upon-Thames
- £28,000 - £35,000 a year
- Full-time
- Customer service
- Organisational skills
- IT
Quick apply
13d
Procurement and Facilities Manager
AXA —Redhill
- £70,000 a year
- Hybrid work
- Bachelor's degree
- Business
- Negotiation
- Employee discount
8d
Assistant Engineering Manager
Arriva London North Limited —London
- £63,000 a year
- Full-time
- Maintenance
- Leadership
- Employee discount
Quick apply
Warehouse Process and Compliance Manager
Gist Limited —Basingstoke
- £55,000 - £65,000 a year
- Full-time
- Hybrid work
- Project management
- Annual leave
- Employee assistance programme
Senior Certification Project Manager
BRE —Watford
- £50,000 - £65,000 a year
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Microsoft Office
- Free parking
13d
Maintenance Manager
Popeyes UK —Ealing
- Full-time
- Maintenance
- Restaurant
- Communication skills
Quick apply
Golf Course Manager
Sunbury Golf Centre —Shepperton
- Full-time
- Organisational skills
- IT
- In-person
- Free parking
- Health & wellbeing programme
Quick apply
8d

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Post-Trial Access Manager, Continued Access - Sponsor Dedicated

IQVIA -
Reading

Apply Now

Job details

Full-time
9 days ago

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.

Apply Now

Refine Your Search

certification manager jobs in datchet, brk

Post-Trial Access Manager, Continued Access - Sponsor Dedicated

Master - London

Health & Safety Manager – Luxury Estate & Hospitality Operations

Building Manager

Fitness & Wellbeing Manager

Estate Manager

Certification Project Manager

Project Manager

Trainee Property Manager

Certification Project Manager

Operations Manager

Channel Enablement & Certification Manager

Training and Development Coordinator

Senior Property Manager

Procurement and Facilities Manager

Assistant Engineering Manager

Warehouse Process and Compliance Manager

Senior Certification Project Manager

Maintenance Manager

Golf Course Manager

I want to receive the latest job alerts for certification manager in datchet, brk

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