PPD Clinical Trials Project Manager Vacancy 2022 – Apply Online
PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose – to improve health.
PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.
Job Title: ASSOCIATE PROJECT MANAGER – CLINICAL SUPPLIES – TISSUE OPERATIONS
Location: FSP Collegeville PA – Collegeville – PA
Education and Experience:
Bachelor’s Degree and at least 2 years of relevant experience
Knowledge, Skills, and Abilities:
• Excellent communication and interpersonal skills with a track record for building relationships both internally and externally.
• An agile thinker, comfortable and adaptable to dynamic and changing working environments.
• Experience in Cell and Gene Therapy Clinical Trials or Commercial Operations preferred
• Experience working with CROs and CMO’s preferred
• Good understanding of GxP and/or GMP
• 3+ years of Laboratory experience and an understanding of biological science
• Good understanding of FACT / JACIE / AABB
• Project management experience/qualification would be an advantage.
• Experience with labeling, packaging and documenting apheresis shipments/receipt of cryopreserved drug product shipments not essential but favorable.
• A focus on compliance to Client procedures and policies is essential.
• Patient focused with integrity as a key value.
Job Responsibilities:
In this role, you would be working with the Client’s Tissue Operations Support group.
- Implement Client supply chain activities at Apheresis/clinical sites either in person or by remote training methods as required. Includes training on Client tracking activities performed at the clinical sites. As such, the role will involve travel throughout North America and Canada.
- Travel is estimated to be three to four hospitals per month throughout USA and Canada with potential for transatlantic travel to UK and Europe. Global travel restrictions could impact travel frequency. If home working, travel to the Client office in Collegeville may be a requirement at an estimated frequency of twice every quarter
- Support supply chain manager in identification and implementation of suitable processes to onboard apheresis and infusion sites for supply chain accountabilities for all assets as applicable within CGT (Cell and Gene Therapy) platform.
- Support clinical sites by providing onsite support with Client processes for Apheresis and Infusion where appropriate.
- Support supply chain manager by identifying gaps, suggesting updates, and implementing aligned changes to appropriate SOPs (Standard Operating Procedures),
- Protocols and training materials. The ultimate aim is to ensure the implementation of vein to vein supply chain activities at Apheresis/clinical sites.
- Develop then monitor adherence of supply chain to parameters through performance management.
- Ensure appropriate actions are taken to resolve any deviation or exceptions to meet customer requirements.
- Work with internal and external business partners to ensure cell collection centers successfully complete all qualification activities and are prepared to perform collections within the required timelines.
- Provide training, as necessary, at investigator meetings and other trial-specific meetings such as site initiation visits.
- Work independently to ensure that clinical site Apheresis/collection functions are current as to equipment, training, and technology according to internal procedures and recommendations.
- Contribute to the development and maintenance of procedures related to standard cell procurement and Apheresis practices.
- Identify potential supply chain challenges and work across the matrix team to minimize the commercial and/ or clinical impact. Close the identified supply chain issue in the shortest possible time.
Contribute as required to any advocacy work. - Travel to third-party organizations for face-to-face meetings and advocacy may be a requirement.
- Responsible for development and implementation of appropriate systems, procedures, and training for compliant management of the product, identifying and managing risks, initiating and leading change control, deviation investigations, and CAPA (Corrective Action Preventative Action).
- Establish good working relationships with clinical teams and sites.
Work closely with the CGT teams to ensure the knowledge gained at sites is effectively communicated. - Support supply chain manager by implementing electronic chain of custody at clinical sites.
- Have a sound understanding of logistic activities at sites and at LSPs (Local Service Providers)
- The Tissue operations Support Specialist would be responsible for at least one of the following key responsibilities and would contribute to other responsibilities: Apheresis/Infusion site Onboarding, Inventory management, Shipments/logistics, Capacity planning, Patient Supply Coordination, Chain of Custody (Track and Trace), Labeling and Operational Finance.
PPD Clinical Trials Project
