The Clinical Project Manager 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 will be 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.
S/he will have a proven ability to independently prioritize and manage multiple tasks and projects with competing priorities and deadlines, screen and prioritize communications and opportunities from external sources. S/he shall have and utilize technical knowledge and build clinical research capabilities, implementing appropriate procedures and policies. The ideal candidate will be dynamic, articulate, high-energy, organized, and able to 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. Position is in-house; may entail approximately 25% travel depending on project needs.
Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts
5+ years clinical research experience in an industry setting and a minimum of 2 years project-lead or management experience
Bachelors 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
Effective oral and written communication
Demonstrated ability to multitask successfully and drive concurrent projects through completion
Possess strong problem solving, organizational, management and interpersonal skills
Work independently with minimal supervision.