Senior Clinical Trial Manager, Clinical Operations 1171412
Job Scope & Purpose:
Our Cambridge-based Microbiome Therapy client is seeking an experienced Clinical Operations professional to join their growing team as a Sr. CTM. This role can be remote.
This role will need to independently organize and manage multiple clinical trial activities including facilitating cross-functional team meetings, managing vendors, and addressing protocol related questions. S/he would also be ensuring that study milestones are met and that the trial is completed in accordance with the protocol and within budget.
The Senior Clinical Trial Manager will function as a member of the clinical team and is responsible for management of all clinical aspects of sponsored clinical trials to ensure compliance with the Clinical Protocol, Standard Operating Procedures (SOPs), Good Clinical Practices and ICH Guidelines.
Primary Job Responsibilities:
- Establish/maintain study milestones and ensure accurate tracking and reporting of study metrics and timelines
- Organize and facilitate/document study cross-functional team meetings
- Setup and review study Trial Master File periodically for quality control measures
- Review and provide input for reports and clinical documents such as informed consent, protocols, Investigator's Brochure, yearly updates to the regulatory authorities and status updates
- Responsible for communication and escalation of study related risks and issues as required
- Ensure study staff is appropriately trained on relevant guidelines, regulations and SOPs
- Assist in the oversight of monitoring activities and site visits
- May represent Clinical Operations in cross-functional initiatives
- Manage and attend Investigator Meetings, conferences, and perform co-monitoring as needed
- People management of junior staff as the team rapidly expands
- Assist with interim and final report and data analysis of clinical trial results
- Provide regular status updates of project progress
- May support inspection readiness, audit preparation, or specific projects related to vendor management, training, and clinical team infrastructure
Primary Job Requirements::
- Demonstrated computer skills including functional knowledge of Microsoft packages and ability to develop proficiency in technical systems and programs
- Experience developing, reviewing, and approving study operational plans including site monitoring and risk mitigation strategies, trial budgets, site feasibility and clinical metrics tracking reports
- Experience managing CROs, vendors, and/or clinical trial consultants
- B.S. (or equivalent experience) and 4+ years of relevant work experience; candidate has to have worked as a CTM, preferably in a Sponsor environment
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