Trial Supplies Manager

Dexian; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

Dexian is seeking a Trial Supplies Manager responsible for supply planning and inventory management in clinical research. This 100% remote position requires strong analytical and communication skills along with experience in the pharmaceutical sector. Ideal candidates will have a solid understanding of the drug development process and excellent project management abilities.

Qualifications

• Strong knowledge of global drug development and regulatory requirements.
• Proficient knowledge of import/export requirements.
• Ability to drive internal team consensus.

Responsibilities

• Responsible for supply planning and inventory management of clinical supplies.
• Collaborating with various teams to ensure timely delivery of supplies.
• Monitoring inventory and allocate strategies based on demand.

Skills

Analytical skills

Communication

Negotiation

Project management

Supply chain management

Education

2 years relevant work experience in pharmaceutical environment

Job description

This range is provided by Dexian. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$75.00/hr - $82.00/hr

Direct message the job poster from Dexian

Job Title: Trial Supplies Manager

Duration: 6+ Months (Possibility of Extension & Conversion depending on Performance)

100% Remote

Shift Timing- EST Hours

Pay range: $75-82/hr on W2 (Without Benefits)

Job Summary:

• 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.
• 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, CROs, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
• 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 projects.
• 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 partners.
• Collaborating with Global Clinical Supply Chain functions and external Vendors on the package design and label development for investigational products to meet all protocol and regulatory requirements.
• 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 required.
• 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 developing proposals outlining solutions.
• Managing conflicts / issues with internal and external partners and customers.
• Demonstrating strong knowledge when presenting clinical supply processes at cross-functional meetings and actively participates.
• Ability to coach new Trial Supply Managers in individual tasks.
• Participating in training efforts for external functions on clinical supply processes to facilitate improved cross-functional relationships.
• Speaking at Investigator Meetings as required.
• Traveling as required (<10%).
• Writing of / input to departmental SOPs.
• Perform other tasks as assigned.

Required:

• 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 plans.
• Team and individual leadership (lead courageously).
• Oral and written communication (fosters open communication).
• Negotiation (Manages Execution, Results Driven, Analysis of Issues, Effective Speaking, Builds Relationships).

Ideal Candidates Would Also Have:

• Coaching and mentoring (fosters teamwork).

Other Qualifications:

• 2 years of relevant work experience required, preferably in a pharmaceutical environment.
• 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.

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Supply Chain, Strategy/Planning, and Sales

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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