Senior Clinical Trial Manager

Are you an amazing clinical trial manager with a passion for getting things done!?
The RoleAs the Senior Clinical Trial Manager, you’ll play a vital role in executing clinical studies within the allocated timeframe and budget, ensuring compliance with clinical SOPs and GCPs. You’ll manage clinical trials from initiation to completion, develop study protocols, case report forms, and clinical reports, and support clinical trials as needed.
Our clientOur esteemed client is a leading company developing innovative solutions that minimize acute and chronic risks associated with gynecologic procedures, and they’re seeking an experienced Senior Clinical Trial of Clinical Operations to join their team.
The Job DescriptionAssist in developing and maintaining clinical SOPs and procedures to ensure efficient and compliant clinical processes.Design and implement pre-market and post-market clinical trials.Develop project plans, budgets, and timelines.Coordinate input from literature, experts, and internal team members to develop study protocols.Select and manage investigational sites, CROs, and external laboratories. Develop study documentation, ensuring thorough data to support the approval process or study objective.Ensure site monitoring meets FDA/GCP/ICH requirements.Serve as a resource to site coordinators, investigators, and other staff members. Manage clinical study reports and regulatory submissions.Prepare scientific abstracts, and manuscripts, and attend relevant scientific/medical meetings.
Qualifications:Bachelor’s degree in health profession, science, or engineering field. Minimum of seven years of clinical affairs experience in the medical device or pharmaceutical industry.Minimum of three years of clinical project management experience. Excellent written and oral communication skills.Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc. Strong organizational skills and attention to detail.
Working Conditions:Ability to travel approximately 35-40% for site selection, training, monitoring, and educational seminars.
Previous Companies:Experience or working with Class II or III Medical Devices is essentialWorking in a startup environment and taking a product through to market.
LocationWe highly prefer candidates based in New England for this role. However, candidates from the East Coast who are open to travel may also be considered. The company’s office is located in Massachusetts.
Specific skill sets:Study Start-UpMedical Device experienceEnrollment Turn aroundMentoring
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