Clinical Project Manager
Job Req code: 686
Category: Clinical Affairs
We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others. Empowering Healing.
Organogenesis corporate headquarters is located in Canton, Massachusetts, and we have an additional site in Norwood, Massachusetts. Our Canton location is the manufacturing site for PuraPly® AM (which heals acute and chronic wounds), and Apligraf® (for the treatment of surgical wounds). Our Norwood location manufactures ReNu® (offering regenerative and anti-inflammatory properties to create an environment that reduces pain) and NuCel® (which provides an enhanced environment for tissue growth, repair and healing). Canton is also the location for Customer Service, Reimbursement and other corporate teams, supporting our full range of products.
The Clinical Project Manager (CPM) will be responsible for managing multiple multi-center, randomized controlled clinical studies in accordance with protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements, preferably including (but not required) 21CFR Part 1271/ 361 Human cells, Tissues, and Cellular and Tissue-Based Products (HCT/P). This position is based at Organogenesis Inc.’s headquarters in Canton, MA, reports directly to the Associate Director of Clinical Affairs, and may entail approximately 25% travel, depending on project needs.
• Responsible for the operational management, oversight, and successful execution of clinical studies from protocol concept through the clinical study report and publication, while ensuring completion of study deliverables.
• Implement and manage clinical development plans and timelines that lead to timely implementation, execution, and analysis of clinical studies in preparation for regulatory submissions. Identify and manage the activities needed to achieve this goal utilizing internal and external resources.
• Establish good working relationships with internal legal, medical, clinical, manufacturing operations, regulatory, marketing, and health care economics teams. Prepare clinical documentation to support reimbursement necessities and marketing messages for post-market studies and regulatory submissions for investigational studies.
• Utilize technical knowledge and build clinical research capabilities, implementing appropriate procedures and policies.
• Support cross-functional coordination in a fast paced environment, assist with developing department staff; and manage consultants and Contract Research Organizations (CROs). S/he will develop and maintain relationships with Investigators and their study staff as well as key opinion leaders.
• 5+ years clinical research experience in an industry setting and a minimum of 2 years project-lead or management experience
• Bachelor’s and/or master’s degree in a scientific discipline, RN, BSN degree or equivalent
• Experience with EDC systems Computer proficiency, including Microsoft Office applications.
• Experience in writing clinical study protocols, informed consent forms, and other clinical documents Has demonstrated ability to multitask successfully and drive concurrent projects through completion
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