Manager - Clinical Supply

Acorda Therapeutics Inc.

(Chelsea, Massachusetts)
Full Time
Job Posting Details
About Acorda Therapeutics Inc.
Acorda Therapeutics is a publicly traded (NASDAQ: ACOR) biotechnology company whose mission is to develop therapies that restore neurological function and improve the lives of people with neurological disorders.
Summary
The Manager – Clinical Supply is responsible for performing critical activities related to the supply of investigational drugs for clinical studies and returns reconciliation. This individual works with Clinical Operations and Medical Affairs to plan and manage supply for Investigator Initiated Studies (IIS) and with Acorda’s vendors to ensure critical information is communicated with respect to manufacturing, packaging and labeling of clinical drug supplies.
Responsibilities
* Supports the Head of Clinical Supply by performing critical activities necessary to ensure an uninterrupted supply of investigation supplies to all of Acorda sponsored clinical trials. * Works with Technical Operations team to schedule manufacturing of bulk drug. * Coordinates the Shipment and Storage of Clinical Trial Materials (CTM) with Technical Operations team. * Supports CTM packaging activities within Acorda to fulfill clinical protocol requirements and to meet clinical timelines. * Provides support for the distribution of all CTMs. * Provides support for the returns and reconciliation of CTMs. * Coordinates with label vendor to generate proofs and obtain required approvals to place order, in conjunction with other Acorda departments. * Collaborates with clinical project manager to develop site drug accountability documentation procedures and forms. * Reviews clinical trial protocols and develops and implements trial specific labeling/packaging/distribution (including re-supplies). * Coordinates with Acorda QA to perform pre and post packaging batch documentation reviews. * Manages the inventory of clinical trial drugs and related supplies. * Assists with the management of logistics between clinical supply vendors.
Ideal Candidate
* Education and/or Experience: * Bachelor’s Degree in Chemistry, Mathematics, Pharmacy or related technical field required. * Master’s Degree in Chemistry, Mathematics, Pharmacy or related technical field preferred. * Minimum of three to five years of experience in the pharmaceutical industry working to provide investigational product supplies for both US/NA and Global studies. * Basic understanding of GCP’s, GMP’s and ICH guidelines and applicable regulatory requirements. * Supervisory Responsibilities: * None * Qualifications: * Basic understanding of fundamental clinical trial designs and the application to packaging and labeling of clinical drug product. * Basic understanding of clinical drug distribution and return/reconciliation activities. * Basic understanding of IRT system setup to support clinical trials * Computer Skills: * Must be proficient in MS Office Suite. * Basic Understanding of ERP systems required. * Certificates, Licenses, Registrations: * none required * Other Skills and Abilities: * Ability to serve on multiple interdepartmental teams and to act as team leader when appropriate. * Strong planning and coordination skills. * Ability to work with individuals across a wide range of disciplines. * Excellent written and verbal communication skills. * Must demonstrate a keen attention to detail and timelines. * Proven ability to work on multiple projects in a fast paced environment.

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