Trial Supply Operations Manager
Our client needs a Trial Supply Operations Manager who sees the world differently. We’re looking for a professional with 3 years of experience who doesn’t see obstacles but opportunity when it comes to the pharmaceutical industry. The Trial Supply Operations Manager position is a contract position for a period of six months and is located in Bridgewater, New Jersey. We’re looking for problem solvers, innovators and those inspired by the work we do in making a difference today and with future generations.
- Contribute to the development and apply the distribution strategy (for IVR and non-IVR studies) that ensures continuity of IP at depots and investigational sites
- Ensure adequate IP stock at depot and site levels
- Support relabeling activity or transfer of IP between various sites
- Ensure all critical parameters are considered for every distribution strategy IVRS and IWRS specifications (e.g. initial or resupply quantities); any QP, project, study, expiry, customs, import or export, brokerage or country specific requirements
- Generate or review IP shipment requests for accuracy and completeness prior to issuance
- Ensure accuracy of IP receipt for all shipments and availability in IVR for applicable studies
- Serve as point of contact for all contracted distribution activities
- Provide adequate communication and documentation (including customs values) relevant to the distribution plan and the movement of all investigational products
- Contribute to the quotation for customers' distribution projects to include budgeting and forecasting
- Generate and maintain data for distribution metrics
- Offer creative solutions and proposals to optimize the distribution supply chain
- Minimum of 3 years of experience in pharmaceutical business required
- Thorough understanding of GMP & GDP (IP production and distribution)
- Thorough understanding of IVR or IWR systems
- Good understanding of CMC and clinical study conduct activities
- Excellent knowledge of business units, scientific core platforms and interfaces, clinical study protocols and IP related activities with particular emphasis on global distribution and strategy
- Experience with MS Office Suite (Excel, Word, PowerPoint), flow diagramming and project management software required
- Bachelor of Science degree (BS) in Health Science or related discipline
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.