Quality - Trial Supplies Manager

Hays; Princeton (NJ); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Quality - Trial Supplies Manager to oversee and optimize the clinical supply chain. This role involves collaborating with various teams to ensure timely supply delivery, managing project timelines, and improving supply strategies for ongoing studies. Ideal candidates will have strong analytical and project management skills, along with a desire to contribute significantly to clinical project success. The position offers competitive compensation and a chance to work in a dynamic environment.

Benefits

Full medical benefits

401K

Life Insurance ($20,000 benefit)

Qualifications

• 2 years of relevant work experience in a pharmaceutical environment required.
• Moderate/Strong knowledge of global drug development and regulatory requirements.
• Ability to coach and mentor.

Responsibilities

• Collaborate with clinical research teams for supply chain management.
• Communicate timelines and strategies to study teams.
• Develop supply forecasts based on clinical plans.

Skills

Analytical skills

Communication skills

Negotiation skills

Project management

Forecasting

Planning

Education

Bachelor’s degree

Job description

The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Quality - Trial Supplies Manager in Princeton, NJ.

Role Description

• 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, BMS 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.
• 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.
• 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 develop 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 on 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.
• Performs other tasks as assigned.

Skills & Requirements

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).
• Conflict resolution (manages disagreements).
• Negotiation (Manages Execution, Results Driven, Analysis of Issues, Effective Speaking, Builds Relationships).

Ideal Candidates Would Also Have:
• Coaching and mentoring (fosters teamwork).

Other Qualifications:
• Bachelor’s degree required.
• 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.

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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#1174894 - Michal Mercier