Clinical Trial Supply Manager
- Ivrea, Italy
AAA Statement Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients' lives by leading innovation in nuclear medicine.
AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).
Clinical Trial Supply Manager (CTSM) defines and executes an optimal clinical trial supply strategy for a clinical trial including effective risk management to ensure supply continuity to patients.
The CTSM is the single point of contact at trial level for the integrated Clinical Trial Team (iCTT). Is responsible for clinical trial supply deliverables within AAA Clinical Supply and all other relevant associated sub-functions, maintaining Quality and Compliance through all activities.
Has operational end-to-end responsibility for assigned activity. Leads and manages all project and local network activities and participates in cross-functional teams.
1. Represents Clinical Supply as a core member in the integrated Clinical Trial Team (iCTT); define and advise the iCTT on the optimal clinical trial supply strategy in terms of, but not limited to, packaging design, technical and timeline feasibility, efficiency and risk management.
2. Reviews overall clinical trial protocol/protocol amendments and other related documents (e.g. Pharmacy manuals), provide input to develop optimal packaging design, clinical trial supply design and visit schedule.
3. Creates and maintain complete and accurate clinical supply demand for assigned study in alignment with protocol requirements, key study parameters and milestones, patient projections, with appropriate overage and by using defined processes and systems.
4. Creates and drive finalization of the packaging design (Clinical Packaging Request) and a comprehensive label strategy for all participating countries in the clinical trial.
5. Defines clinical supply parameters for IRT set up and initiates subsequent updates through-out the duration of the clinical trial.
6. Develops and executes a trial-level project plan together with all other relevant roles.
7. Identifies, assesses and proactively communicates supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity.
8. Collaborates with all relevant line function partners for country submission and approval timelines (including IND-IMPD amendment) to develop optimal supply strategy.
9. Generates optimal distribution plans for investigational medicinal products (IMPs), jointly with partner functions. Triggers and track shipments of IMPs from central depot to regional hubs and local depots.
10. Develops, maintains and executes and optimal resupply strategy with proactive planning, appropriate lead-time and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expire management of clinical supplies.
11. Is responsible to consolidate, maintain and track the clinical trial budget with key stakeholders for overall AAA Clinical Supply external cost (e.g. labels, packaging, distribution and comparators).
12. Actively contributes to the Global Supply Chain sub team as a full member. Ensures adequate, proactive exchange of relevant knowledge & information between the Global Supply Chain sub team and the CTT.
13. Fully supports, prepares the project leaders, to adequately address Clinical Supply-considerations at various cross-functional teams.
1. Ensures compliance of processes with regulations as well as Company internal procedures and GxP requirements.
2. Actively participates in teams activities and fulfills all related tasks and responsibilities related to own discipline.
3. Proactively communicates key issues and any critical topic in a timely manner to the appropriate management level and to/or any other relevant project team members. Interprets results, evaluate data, draw conclusions and report back to team and management.
4. Gives guidance to team members. Provide coaching and technical training as subject matter expert or recognize technical expert. Act as mentor for junior and senior associates.
5. Actively contributes to team goals.
6. Monitors and reports performance measures to enable strategic objective to be met, or corrective action to be taken.
7. Executes the activities part of the strategic plan.
Education: Degree in science, engineering or equivalent
Languages: Fluency in English
Experience / Professional requirements:
1. Good expertise in related field (>4 years of practical experience)
2. Good knowledge about the drug development process
3. Basic project management skills, good organization and planning skills
4. Knowledge of relevant regulations (e.g. GCP, GMP, GDP, etc.)
5. Demonstrate problem-solving and idea generation skills
6. Experience using IRT systems and document management systems
7. Very good communication, negotiation and interpersonal skills
8. Excellent organization and planning skills. Ability to work in interdisciplinary and cross-cultural teams
Work location: Ivrea (Italy) or Switzerland - preferred or any AAA/Novartis site in European time zone
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding,inclusive work environment and diverse team's representative of the patients and communities we serve.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:https://talentnetwork.novartis.com/network
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