Manager Work, Jobs in Chalgrove, Oxf (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
Internal Communications and Engagement Manager
Affinity Trust —Thame
- £40,000 a year
- Full-time
- Hybrid work
- SharePoint
- Employee assistance programme
6d
Account Manager
KNAPP U.K. Limited —Chalgrove
- Full-time
- Sales
9d
Regional Manager (Catering) - Oxfordshire/Berkshire
Eurest —Didcot
- Up to £65,000 a year
- Management
- Contracts
- Leadership
13d
Residence Manager
UPP Ltd —Oxford
- £39,702 a year
- Nights as needed
- Team management
- IT
- Communication skills
- Annual leave
- Employee discount
9d
School Holiday Camp Manager
Active Learning Group —Abingdon
- £688.75 - £760.00 a week
- Full-time
- Childcare
- In-person
- School
- Employee discount
Quick apply
1d
Operations Manager
Popeyes UK —Reading
- £55,000 - £65,000 a year
- Full-time
- Casual dining restaurant
- Leadership
- Annual leave
- Employee discount
Quick apply
Head of Operations
Abingdon Gymnastics Club Limited —Berinsfield
- £40,000 - £45,000 a year
- Full-time
- Management
- Customer service
- Supervising experience
- Free parking
- Annual leave
Quick apply
Housing and Partnership Manager
Affinity Trust —Thame
- £45,000 a year
- Full-time
- Hybrid work
- Management
- Communication skills
- Employee assistance programme
9d
Duty Manager
George Hotel —Dorchester
- Up to £13.15 an hour
- Full-time
- Leadership
- Employee assistance programme
- Employee discount
Quick apply
Repairs and Compliance Manager
Affinity Trust —Thame
- £45,000 a year
- Full-time
- Hybrid work
- Maintenance
- IT
- Employee assistance programme
9d
Head of Events
Hurley House Hotel —Maidenhead
- £60,000 a year
- Full-time
- Hospitality
- Sales
- Microsoft Office
- Employee discount
- Referral programme
Quick apply
8d
General Manager
DHL —Didcot
- £60,000 - £70,000 a year
14d
Duty Manager
SouthOxfordshireAndVale —Didcot
- £33,565 - £39,271 a year
- Supervising experience
- Organisational skills
- Communication skills
- Flexible schedule
Quick apply
3d
Trainee Duty Manager
Serco Plc —Oxford
- £15.06 an hour
- Part-time
- Customer service
- Communication skills
- Annual leave
Head of Operations
Tomorrow's Guides —Hungerford
- Full-time
- Hybrid work
- Master's degree
- In-person
- Leadership
- Free parking
- Annual leave
Quick apply
Library Manager (Stock, Events and Engagement lead)
OXFORDSHIRE COUNTY COUNCIL —Oxford
- £34,434 - £37,280 a year
- Part-time
- Organisational skills
- Employee discount
18h
Customer Relationship Lead
Majesticare —Haddenham
- £43,000 - £47,000 a year
- Employee discount
Quick apply
4d
Duty Manager
GLL —Abingdon
- £29,751.23 a year
- Management
Heads PA (Full time, term time only)
Davenies School —Beaconsfield
- £40,000 - £50,000 a year
- Full-time
- Microsoft Outlook
- Administrative experience
- Travel
- Free parking
- Health & wellbeing programme
Quick apply

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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

manager jobs in chalgrove, oxf

Post-Trial Access Manager, Continued Access - Sponsor Dedicated

Internal Communications and Engagement Manager

Account Manager

Regional Manager (Catering) - Oxfordshire/Berkshire

Residence Manager

School Holiday Camp Manager

Operations Manager

Head of Operations

Housing and Partnership Manager

Duty Manager

Repairs and Compliance Manager

Head of Events

General Manager

Duty Manager

Trainee Duty Manager

Head of Operations

Library Manager (Stock, Events and Engagement lead)

Customer Relationship Lead

Duty Manager

Heads PA (Full time, term time only)

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