Oversee and coordinate the start-up, progress and closure of clinical research projects.
Guide and support the project team to ensure adherence with project objectives, timelines and budget. Supervise activities and measure performance of project team (in-sourced and out-sourced) against project plan.
Responsible for the design and implementation of pre-market and post-market clinical studies.
Develop and manage the project plan including a budget and timeline.
Facilitate the development of study protocols by coordinating input from various sources including literature, experts, and internal team members.
Select and manage investigational sites and clinical study vendors such as CROs and external laboratories. Review project monitoring and site management plans and contracts.
Facilitate the development of study documentation including case report forms, informed consent forms, source documentation and study-specific plans for sound and thorough data to support the approval process or study objective.
Ensure monitoring is sufficient such that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements and fulfills the study objective. Ensure study tracking and databases are maintained updated.
Pro-actively identify project specific issues and develop strategies and plans to address.
Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols.
Manage the clinical study report as well as the clinical portion of regulatory submissions. Prepare scientific abstracts and manuscripts.
Coordinate and cooperate with third party vendors if applicable (e.g., Core laboratory, consultants, etc.).
Drive and lead project meetings and facilitate timely and accurate communication between the sites. Keeps management team proactively informed about clinical study progress.
Review budgets on a regular basis to ensure all project costs are thoroughly tracked and controlled.
Performs other duties as assigned.
Education and Experience:
Minimum Requirements:
Bachelor's degree in life/health sciences or related discipline, or equivalent; Master's degree preferred. 4 - 6 year's relevant clinical study management experience with emphasis in the diabetes industry and/or equivalent combination of education and experience. Medical devices experience preferred. CDE preferred.
Preferred Skills and Competencies:
Strong management skills with demonstrated ability to manage projects and resources.
Strong communication (verbal and written) and interpersonal skills.
Strong attention to detail and exceptional follow-up skills.
Demonstrated analytical and problem-solving skills.
Strong initiative, sense of urgency, and commitment.
Solid organizational skills with the capacity to prioritize and multi-task.
Excellent written and oral communication skills.
Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
Physical Requirements:
Ability to travel approximately 35-50% depending on study.
We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who ex
Benefits
Health insurance
Additional Information
Job Summary
Position Overview:
This role will manage clinical studies from initiation to completion through leading or participating in the development of protocols, case report forms and clinical reports, as well as performing site monitoring visits and interfacing with site staff, Clinical Research Organizations (CRO), and other company representatives. Additional accountabilities include: providing project managing oversight to all aspects of the clinical study, maintaining quality and integrity of study data in accordance with company SOPs, applicable laws, regulations and guidelines; reporting to all relevant parties on a regular basis and managing the clinical research project budget.
Insulet · London, UK