Clinical Team Manager
TELECOMMUTE – Employee
Clinical Team Manager (FHI Clinical)
The Clinical Team Manager (CTM) will lead cross-functional teams with Project Management, Clinical Operations, and Regulatory Affairs, while understanding and managing client expectations. The Clinical Trial Manager is responsible for the day-to-day management of clinical projects, including direct communication and interaction with clinical sites, CRAs and third-party vendors. This position ensures the on-time and high-quality delivery of project-specific on-site and remote monitoring; accountability of clinical monitoring compliance, tracking of critical project tasks; strategic study enrollment support including project-specific enrollment planning and project accountability. This role will be responsible for the identification, resolution/mitigation and escalation of risks related to the monitoring of the trial.
Manage the quality and clinical operations of assigned studies while remaining ICH GCP compliant
Collaborate with the Project Manager in order to prepare, organize, and present investigator meetings.
Deliver documents and study materials for the clinical department in a timely manner.
Perform reviews of monitoring visit reports and confirm alignment with timeline.
Support clinical trials as needed in order to measure performance and ensure duties are met.
Establish and maintain the tracking tools for assigned trials, including project files both electronically and in the Trial Master File and Project Status Reports.
Proactively identify and resolve issues and participate in process improvement initiatives.
Develop and track study timelines, budget, and quality metrics.
Manage study investigators, study sites, clinical monitors, clinical field specialists and third- party GCP vendors.
Conduct regular meetings with clinical, quality, and regulatory teams to assess and mitigate emerging or potential risks.
Collaborates with study team to ensure data milestones are met.
Supports auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines and applicable regulations.
Other duties as assigned.
Knowledge, skills and abilities:
Knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management.
Strong communication skills (verbal and written) to express complex ideas.
Excellent organizational and interpersonal skills.
Positive attitude and ability to interact with all levels of staff.
Must be able to manage multiple tasks and have a level of flexibility that can support group priorities across the Company.
Ability to mentor and train clinical staff.
Working Knowledge of Word, Excel, and Power Point.
Working knowledge of current ICH/GCP guidelines and applicable country specific regulations.
Willingness and ability to travel domestically and internationally as required.
Education: Bachelor’s degree or its international equivalent.
Preferred Job-related Experience:At least two (2) years of experience managing clinical trials within a CRO.Extensive knowledge of FDA, international regulatory regulations, GCP, ICH guidelines and regulatory requirements for clinical trial management. Prior experience in electronic data capture systems required. Strong knowledge of clinical trial processes.
Additional Eligibility Qualifications: Strong written and verbal communication and …
Medical & Health , Medical Research , Pharmaceutical
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