Trial Supplies Manager
Trial Supplies Manager
Job Number: 21-07023
Job Number: 21-07023
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Trial Supplies Manager for our client in Summit, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Create and maintain supply strategies for all investigational product based on the scientific and regulatory confines of the drug's development with minimal supervision.
- Proactively defines, plans, and communicates the clinical supply chain strategy in support of global clinical studies to promote optimal use and alignment with study and corporate goals.
- Demonstrates strong knowledge of Client processes when presenting at cross-functional meetings.
- Responsible for identifying and supporting strategies for continuous improvement, both departmental and/or inter-departmental.
- Influences clinical and development timelines, study design and country selection.
- Directly responsible for reviewing and providing input to draft clinical protocols, communicating timelines and investigational product strategies to study and cross-functional teams.
- Develops supply forecasts for studies through evaluation of the clinical development plan and protocol analysis.
- Monitors inventory and analyzes drug utilization versus forecast taking into account country requirements and logistical timelines.
- Issues Manufacturing and Packaging/Labeling requests to Clinical Supply Operations (CSO) in alignment with RDSC Master Planning timelines and based on collaboration with Clinical Development team, Chemistry, Manufacturing & Controls (CMC) team and CSO Packaging and Labeling to ensure package design and clinical label for investigational product meet protocol and regulatory requirements.
- Monitor use date of investigational drug product for assigned protocols. Support use date extension activities, such as generation of Use Date Extension (UDE) memo, and provide feedback to Logistics team to support generation of UDE labels for depots and clinical sites.
- Ensures timely delivery of quality clinical supplies for all assigned compounds and protocols by collaborating with internal and external sources while taking into account country Regulatory and QP Release requirements.
- Participates in development, review and approval of Interactive Response Technology (IRT) specifications.
- Develops investigational product distribution strategies and maintains distribution and supply strategies at depot and site level according to study and IRT requirements.
- Actively participates in internal Trial Supply Management and Clinical Supply Chain meetings, Study Team meetings, Clinical Supply Matrix Team meetings and any other relevant meetings providing all relevant data and documentation prior to each meeting, highlighting any risks and mitigation strategies.
- Collaborates with Clinical Supply Strategic Sourcing team to procure commercial drug in alignment with country and clinical study requirements. Attends meetings with vendors and generates purchase requisitions as needed.
- Actively supports the budget process by maintaining supply and demand estimates for assigned studies in Budget Tool and by regularly reviewing and updating against revised clinical plans.
- Acts as the main Clinical Supplies contact person for the assigned compound and associated studies, leading communications regarding global supply strategy with study team as appropriate.
- Supports associated actions stemming from change controls.
- In collaboration with Compliance, prepare eTMF, CSR appendices and batch listings to support inspection readiness activities.
- Enters product complaints and deviations in appropriate system and works with PDQ for investigation and resolution.
- Manages conflicts/issues with internal and external partners and customers.
- Writing of departmental procedural documents as applicable.
- Performs other tasks as assigned.
- Minimum 2 years Pharma industry related experience.
- Minimum 1 years Clinical Supplies/Development with global experience or equivalent experience.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Jay Lucas | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.