Clinical Trial Supply Manager

Job description

Details:

Job Purpose:

We are currently seeking a Clinical Trial Supply Manager (CTSM) to join our TRD GMP Manufacturing and Clinical Supply department. If interested, please read further.

The Clinical Trial Supply Manager (CTSM) is the main point of contact for clinical supplies between Clinical Operations and the Clinical Trial Supply Unit (CTSU).

The CTSM is responsible for the supplies used in a clinical trial from start to end, from forecasting until delivery onsite and beyond (IMP reconciliation)

Key Responsibilities:

- Point of contact for clinical (central and region) for study related logistic aspects
- Review protocol
- Coordinate the feasibility assessment and risk analysis/mitigation for all logistic aspects of a clinical trial
- Translate the protocol in a logistic demand
- Define – in collaboration – the packaging and randomisation strategy
- Define – in collaboration – the shipment and resupply strategy
- Define – in collaboration – the labelling strategy
- Coordinate the Demand Management in SAP
- Coordinate the Demand Management of any non-standard study-related requests outside SAP
- Review any study specific procedures, documents, presentations, …
- Assess and find agreement on delivery needs with client and communicate corresponding timelines and any changes to the delivery dates to the client
- Ensure operational activities are timely included and updated as applicable in the Planning
- Point of Contact for study related questions, process clarifications/deviations, training needs, complaints, quality,…
- Participation in projects as lead or contributor as assigned by Management
- GCP audit Coordination (study related)
- Continuous improvement: raise process improvements, developments …
Coordinate SOP deviations (study-related)

Our Offer:

At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.

The department:

Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation's three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.
When it comes to developing the vaccines of the future, we're looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.
We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.

Our Company:

GSK is a science-led global healthcare company with a mission to help people do more, feel better, live longer. At GSK, we research, manufacture and make available a broad range of medicines, vaccines and consumer healthcare products.

GSK Vaccines is a world's leading company, involved in vaccine research, development and production. We have 16 candidate vaccines in development and our broad portfolio of around 40 vaccines prevent illnesses such as hepatitis A, hepatitis B, diphtheria, tetanus, whooping cough, measles, mumps, rubella, polio, typhoid, influenza and bacterial meningitis. Globally, we have more than 16.000 people working to deliver vaccines safely, every day, to people in 90% of the world's countries. In 2014 we distributed around 800 million doses of vaccine, 80% of them to least developed, low and middle income countries.
For further information, please visit www.gsk.com.

*LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.

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Desired profile

Basic qualifications:

- Master degree in Sciences or equivalent, or other relevant discipline
- Good Clinical Study knowledge (3 to 5 years of experience)
- At least 3 years experience in Project Management

Preferred qualifications:

- Good level of written and spoken English
- Strong knowledge of GCP/GMP/quality standards
- Knowledge of Clinical Trial Supplies Operations (Labelling/Pack/WH/Distribution)
- Product & Production knowledge is an asset