Quality - Trial Supplies Manager

Remote Position

This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4. The individual must partner closely with clinical, regulatory, quality and production associates to ensure timely delivery of supplies to study participants.

Responsibilities:

1. Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
2. Working with teams for optimal use of the investigational material supply chain to achieve study and corporate goals.
3. Identifying and supporting strategies for continuous improvement and departmental and/or inter-departmental projects.
4. Co-creating clinical and development timelines and directly responsible for communicating timelines and investigational product strategies to Study Teams as well as cross-functional teams.
5. Proactively defining, planning, and communicating clinical supply strategy in support of global clinical studies, as well as monitoring and reacting to unforeseen clinical demand changes.
6. Developing supply forecasts through evaluation of the clinical development plan and protocol analysis.
7. Reviewing and providing input for draft medical protocols to develop packaging and labelling configurations and create packaging specifications in collaboration with Clinical Operations partners.
8. Collaborating with Global Clinical Supply Chain functions and external Vendors on the package design and label development for investigational product to meet all protocol and regulatory requirements.
9. Monitoring long-term inventory and allocation strategies considering drug recertification, country specific regulatory requirements, international drug shipment and overall demand.
10. Performing analytical assessments of drug utilization as it pertains to current forecasts versus inventories and creating product orders as needed.
11. Working with third party vendors to ensure the timely, efficient, high quality, cost effective execution of all outsourced clinical supply activities.
12. Ensuring releasable supplies for all assigned compounds and Protocols considering country Regulatory and QP Release documentation and requirements.
13. Initiating, reviewing and approving IRT specifications. Participating in user acceptance testing.
14. Developing investigational product distribution strategies maintaining distribution and supply strategy at depot and site level according to study (and IRT) requirements.
15. Actively participating in Trial Supplies Management Functional team, Study Team, Country Medical Affairs Affiliate & CSC Matrix Team Meetings providing all relevant data and documentation prior to each meeting, highlighting any risks and mitigation required.
16. Actively supports the CSC Budget Process.
17. Acting as the main Clinical Supplies contact person for the assigned Compound and associated studies, lead communications regarding global supply strategy with Study Team or Country Affiliate Medical Affairs team as appropriate.
18. Proactively identifying strategic and operational issues and develop proposals outlining solutions.
19. Managing conflicts / issues with internal and external partners and customers.
20. Demonstrating strong knowledge when presenting clinical supply processes at cross-functional meetings and actively participates.
21. Ability to coach new Trial Supply Managers on individual tasks.
22. Participating in training efforts for external functions on clinical supply processes to facilitate improved cross-functional relationships.
23. Traveling as required (<10%).
24. Writing of / input to departmental SOPs.
25. Performs other tasks as assigned.

Required Qualifications:

1. Moderate / Strong knowledge of the global drug development process and global regulatory requirements.
2. Proficient and strong analytical skills.
3. Strong communication and negotiation skills.
4. Proficient and strong Project management skills.
5. Strong knowledge of Forecasting and Planning and proficient knowledge of related areas, i.e. Manufacturing, Packaging & Labelling, IRT, Logistics, Quality, Stability, etc.
6. Proficient knowledge of import / export requirements.
7. Proficient/Strong knowledge of IRT and CTMS systems.
8. Proficient / Strong knowledge of industry technology.
9. Applies and drives Forecasting and Planning activity as it relates to protocol.
10. Ability to build/drive internal team consensus.
11. Translates broad strategies into specific objectives and action plans.
12. Team and individual leadership (lead courageously).
13. Oral and written communication (fosters open communication).
14. Conflict resolution (manages disagreements).
15. Negotiation (Manages Execution, Results Driven, Analysis of Issues, Effective Speaking, Builds Relationships).

Ideal Candidates Would Also Have:

1. Coaching and mentoring (fosters teamwork).

Other Qualifications:

1. Bachelor's degree required.
2. 2 years of relevant work experience required, preferably in a clinical supply environment.
3. An equivalent combination of education and experience may substitute.

As a key partner to many functions within the clinical supply chain and the broader research and development business, this opportunity provides access to a wealth of learning and development possibilities within the pharmaceutical business.