The Clinical Trials Manager is accountable for supporting clinical trial management with the implementation and conduct of clinical trials, focusing on the areas of trial planning, enrollment, site monitoring, data quality, and study reporting. Responsibilities include implementing trial set-up, execution, oversight and reporting for clinical studies while ensuring the trials are conducted in compliance with the protocol, ICH/GCP, and applicable regulatory requirements. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job.
Manages the operational aspects of clinical trials
Participates in protocol, CRF development, Clinical Study Report preparation, as appropriate
Prepares metrics and updates for management, as assigned
Proactively identifies potential study issues/risks and recommends/implements solutions
Participates in and facilitates CRO/vendor selection process for outsourced activities
Manages CRO interactions, including sponsor oversight of operational function activities (eg, study management, monitoring, site management, trial master files)
May work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
Prepares and/or reviews/approves study-related documents (eg, Monitoring Plan, Study Manuals, and CRF-Completion Guidelines)
Reviews site study documents for accuracy and completeness (eg, informed consent template, study tools/worksheets, monitoring visit reports and letters, data listings, etc.)
Recommends and implements innovative process ideas to impact clinical trials management
Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
Participates in the development, review and implementation of departmental SOPs and processes
At least 5+ years of clinical trial (Phase 2 & 3) management experience in the pharmaceutical or biotechnology industry.
BS or BA in a relevant scientific discipline.
Experience in cell immunotherapy is desirable. Experience in transplantation is a plus.
Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.
Experience in management of vendors.
Requires proven project management skills and study leadership ability.
Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks.
Ability to multi-task and shift priorities quickly.
Must have excellent interpersonal, written and verbal communication skills.
Knowledge of FDA Regulations, ICH Guidelines, and GCP governing the conduct of clinical trials.
Medeor Therapeutics is a private, clinical-stage biotechnology company dedicated to the discovery, development and commercialization of transformative and personalized cellular immunotherapies to improve outcomes in organ transplant recipients.