Trial Supplies Operational Manager (all genders)

Descripción del puesto:

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

This role can be done in a hybrid model, 3 days from the office in Warsaw

Your role:

The Trial Supply Operational Manager (TSOM) is responsible for planning, organizing, and delivering all clinical trial supplies (IMP, non-IMP, equipment, and other materials). The role ensures supplies are available on time, meet quality standards, and support the study plan. The TSOM works closely with Clinical Trial Supply Managers (CTSM), vendors, and study teams. The role also leads the supply activities for Post-Study Access (PSA) to ensure eligible participants can continue receiving treatment after the trial ends. You will lead the planning and execution of clinical trial supplies (IMP, non-IMP, auxiliaries, equipment, etc.), that is aligned with clinical trial plans, timelines and regulatory standards. Collaborate closely with CTS manager and supplies vendors in establishing timelines of clinical supplies ordering, labelling, release, distribution and return/destruction. Request for Proposal (RfP) from various supplies vendors, negotiate contracts and manage performance to ensure quality and reliability of supplies. Oversee the setup and management of IVRS and any other systems related to trial supplies (e.g. Temp logger tracking, Fitbit, etc.). n this role, you will oversee end-to-end clinical trial supply operations by ensuring strict compliance with ICH/GCP and GMP regulations, managing supply budgets and forecasting, and maintaining full readiness for regulatory inspections. Additionally, you will develop essential training materials and pharmacy manuals, proactively mitigate supply chain risks, and serve as the primary escalation point for critical issues-such as temperature excursions or quarantined stock-to guarantee uninterrupted supply continuity. Develop and maintain the Post-Study Access (PSA) supply strategy in alignment with protocol requirements, ethical obligations, local regulations, and corporate policies. Develop and Implement that PSA plan with clinical teams, country operations, Clinical Trial Supplies and Global Regulatory Affairs, to ensure uninterrupted access for eligible participants. Serve as the operational point of contact for PSA-related queries from study teams, investigators, and external supply vendors.

Who you are:

* Life Sciences (e.g., Biology, Pharmacy, Pharmaceuticals) degree or equivalent qualification

* Minimum 5 years in clinical development, with at least 3 years focused on clinical supply chain and inventory management.

* Good knowledge of regulatory requirements for clinical trial supplies, including GCP and GMP requirements.

* Experience in Post-Study Access activities would be advantageous

* Experience in IRT systems and supplies forecasting tools.

* Strong Project Management abilities (timeline, scope, budget, risk management), with the ability to manage multiple projects simultaneously.

* Record of successful vendor management

* Demonstrated problem solving, attention to details and resulted oriented behaviors in a fast-paced environment.

* Strong communication skills - excellent verbal and written communication skills with the ability to present complex information clearly and concisely; proficient in English.Critical thinking and proactive mindset

* Ability to work in intense, fast paced, matrixed, multinational work environment, fostering collaboration within and across functional areas.

YOUR MAIN BENEFITS:

* Health and well-being: Get access to private medical care, life insurance, and sports card, receive prepaid lunch card

* Work-Life balance: Enjoy additional paid days off, flexible working hours.

* Learning and Development: Take advantage of co-financing for language courses, trainings, and certifications as well as other development opportunities

* Employee support and engagement: Benefit from Employee Assistance Program and join employee engagement groups for support and connection.

Information on how we process your personal data for recruitment purposes, you can find on the registration form in our Recruitment Portal.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Job Requisition ID: 296420

Location: Warszawa

Career Level: D - Professional (4-9 years)

Working time model: Full-time

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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