Description:
Clinical Supply Set-up Manager

Location: Braine l'Alleud, Belgium

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently looking for a Clinical Supply Set-up Manager for one of our clients, a leading international BioPharmaceutical company.

For our client-facing positions, you must be confident and be able to drive the role and yourself and to work autonomously . You will have a close relationship with our Line Managers, who will provide you with mentoring and guidance. Most of our roles are permanent positions with CROMSOURCE and you will be working on studies for just one client. We are open, friendly and approachable and aim to support you through the recruitment process every step of the way.

The Clinical Supply Set-Up Manager is accountable for the project management of the set-up of study supply and new capabilities at Clinical Trial Supplies (CTS) Department.

He/she plans, coordinates and communicates clinical supply activities for all applicable clinical trials during their set-up phase, aiming to achieve optimal quality, time and budget.

He/she implements the strategy defined in collaboration with stakeholders and provides visibility on clinical supply chain during trial set-up.

Responsibilities:

• Gathers and challenges clinical and supply assumptions to trigger the study supply optimization
• Defines an Investigational Medical Product (IMP) supply strategy to ensure adequate and sufficient forecasting of IMP. Establish production plan, distribution plan and IRT settings for the start of the study
• Provides input to protocol content, country selection and clinical risk databases
• Defines or selects packaging configuration and labeling strategy
• Coordinates an optimal IMP distribution strategy to ensure timely delivery to clinical sites
• Uses project management techniques to manage effectively and efficiently the set-up of assigned phase 1-4 trials, or the set-up of new capabilities for CTS
• Creates and maintains project plans, defining and achieving through the lead of cross functional teams the planned milestones regarding clinical supply set-up activities including packaging, labeling, distribution, Interactive Response Technology (IRT) and other supply systems.
• Ensures Clinical Supply Lead visibility on study supply set-up activities for assigned trials, proactively identifying risks and escalating issues
• Contributes to IRT specification development by defining the requirements for IMP/inventory management. Coordinates and/or participates in User Acceptance Testing.
• Issues or coordinates availability of supply set-up documents
• Ensures timely and cost effective supply availability for study start

Profile:

• Master or Bachelor degree in Life Sciences.
• Minimum of 2 years of Supply Chain expertise
• Experience in Clinical Trials will be considered as an asset
• Analytical mindset
• Project Management experience (in a leading function)
• Results oriented
• Gathering and interpreting information
• Leading others
• Fluent in English

Our benefits when working in Belgium:

• Competitive Salary
• Group and hospitalisation insurance
• Electronic meal vouchers
• Internet reimbursement
• Company Car with fuel card depending on the function
• Dedicated Line Manager
• Regular face-to-face or phone meetings with line manager
• Full annual performance review process
• Ad-hoc team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement

If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001676 .

If you would like to discuss the role before applying through the website, please contact vanessa.verdickt@cromsource.com for more information.

Why TalentSource Life Sciences/CROMSOURCE:

TalentSource Life Sciences is a fully dedicated flexible resourcing department at CROMSOURCE, a family owned international, full-service Contract Research Organisation. CROMSOURCE comes from the merger of MSOURCE and CROM and we have been supporting clients with outstanding clinical research and resourcing services since 1994. Successful growth has been achieved by putting high quality and client focus at the heart of everything we do and we are proud to partner with industry leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide.

Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our current below industry average turnover rates.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are experts providing experts - highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world.

Key words:

Clinical Supplies Set-up, IMP, Clinical Supply Management, Project Management, Outsourcing, BioPharma

Skills: IMP, Project Management, CRO Location: Belgium