Clinical Trial Supplies Manager
Company: Alpha Consulting
Posted on: March 17, 2023
- CLINICAL TRIAL SUPPLIES MANAGER -This is a Remote position.
Work Schedule is Mon - Fri, Business Hours. -Project
- 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
- The individual must partner closely with clinical, regulatory,
quality and production associates to ensure timely delivery of
supplies to study participants.
- 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's 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
- Working with teams for optimal use of the investigational
material supply chain to achieve study and corporate goals.
- Identifying and supporting strategies for continuous
improvement and departmental and/or inter-departmental
- 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.
- 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.
- Developing supply forecasts through evaluation of the clinical
development plan and protocol analysis.
- Reviewing and providing input for draft medical protocols to
develop packaging and labelling configurations and create packaging
specifications in collaboration with Clinical Operations
- 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
- Monitoring long-term inventory and allocation strategies
considering drug recertification, country specific regulatory
requirements, international drug shipment and overall demand.
- Performing analytical assessments of drug utilization as it
pertains to current forecasts versus inventories and creating
product orders as needed.
- Working with third party vendors to ensure the timely,
efficient, high quality, cost effective execution of all outsourced
clinical supply activities.
- Ensuring releasable supplies for all assigned compounds and
Protocols considering country Regulatory and QP Release
documentation and requirements.
- Initiating, reviewing, and approving IRT specifications.
Participating in user acceptance testing.
- Developing investigational product distribution strategies
maintaining distribution and supply strategy at depot and site
level according to study (and IRT) requirements.
- 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
- Actively supports the CSC Budget Process.
- 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.
- Proactively identifying strategic and operational issues and
develop proposals outlining solutions.
- Managing conflicts / issues with internal and external partners
- Demonstrating strong knowledge when presenting clinical supply
processes at cross-functional meetings and actively
- Ability to coach new Trial Supply Managers on individual
- Participating in training efforts for external functions on
clinical supply processes to facilitate improved cross- functional
- Speaking at Investigator Meetings as required.
- 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.
- Traveling as required (
- Writing of / input to departmental SOPs.
- Performs other tasks as assigned. -Required Skills:
- Bachelor's degree required.
- 2 years of relevant work experience required, preferably in a
- An equivalent combination of education and experience may
- Moderate / Strong knowledge of the global drug development
process and global regulatory requirements.
- Proficient and strong analytical skills.
- Strong communication and negotiation skills.
- Proficient and strong Project management skills.
- Strong knowledge of Forecasting and Planning and proficient
knowledge of related areas, i.e., Manufacturing, Packaging &
Labelling, IRT, Logistics, Quality, Stability, etc.
- Proficient knowledge of import / export requirements.
- Proficient/Strong knowledge of IRT and CTMS systems.
- Proficient / Strong knowledge of industry technology.
- Applies and drives Forecasting and Planning activity as it
relates to protocol.
- Ability to build/drive internal team consensus.
- Translates broad strategies into specific objectives and action
- Team and individual leadership (lead courageously).
- Oral and written communication (fosters open
- Conflict resolution (manages disagreements).
- Negotiation (Manages Execution, Results Driven, Analysis of
Issues, Effective Speaking, Builds Relationships).
- Coaching and mentoring (fosters teamwork). -This 12+month
position starts ASAP. -Please E-MAIL your resume (attachment to
email) with rate and availability to Bridget: -ALPHA'S REQUIREMENT
#23-00410MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2
Keywords: Alpha Consulting, Trenton , Clinical Trial Supplies Manager, Executive , Trenton, New Jersey
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