Senior Clinical Project Manager
85 Dan Road, Canton, Massachusetts, 02021, United States
Job Req code 114
Category: Clinical Affairs
The Senior 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 wound care 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.
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 and requires approximately 25-40% travel.
- Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts
- Assesses the operational feasibility of studies and recommends execution and risk mitigation plans
- Co-monitors as needed
- Develops and tracks study timelines, budget, and quality metrics
- Ensures appropriate clinical resources are available for the clinical project
- Ensures GCP and regulatory compliance is maintained
- Leads the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
- Maintains professional expertise through familiarity with therapeutic area and clinical research literature
- Manages clinical projects from concept through clinical study report/ publications of clinical study results
- Oversees clinical research study conduct
- Organizes and leads the clinical project team.
- Participate in cross-functional study team meetings with internal and external resources
- Participates in CRO and other vendor selection, negotiation and management, including monitoring of associated budgets and contracts
- Participates in meetings with clinical sites, key opinion leaders and consultants as needed
- Plays a part in the analysis, summary, and reporting of clinical data through the course of the study
- Aides in the training and development of all clinical staff members
- Proactively identifies and resolves issues, and participates in process improvement initiatives as required
- Responds promptly and appropriately to study questions and issues raised by clinical sites, vendors, monitors, and consultants
- Evaluates monitoring reports with significant findings to confirm appropriate conclusions and actions taken