[Hiring] Clinical Trial Manager @MedTrials

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Clinical Trial Manager (CTM) is responsible for meeting project deadlines, providing ongoing project status reports, overseeing clinical site monitoring and site management deliverables, and tracking/controlling monitoring and site management budget and project assumptions.

• Lead the planning, execution, and oversight of clinical site monitoring and management activities as defined by contract and other applicable plan documents.
• Collaborate with the PM to establish clinical monitoring plans (CMP) for projects.
• Oversee and monitor clinical deliverables and metrics to ensure team compliance with Key Performance Indicators (e.g., site visit compliance, Monitoring Visit Report (MVR) compliance, SDV%).
• Provide routine clinical updates on the status of assigned responsibilities (e.g., status reports, client teleconferences, internal project review).
• Escalate project issues per applicable SOPs and project plan documents.
• Support and contribute to active management of project scope and budget, ensuring accurate forecasting of clinical site monitoring and management activities.
• Support development of budget amendments for clinical team activities, as requested.
• Calculate and submit requisitions for periodic investigator grant payments.
• Attend and participate in external team meetings, including kick-off and investigator meetings.
• Serve as back-up support for the PM for external team teleconferences.
• Develop and maintain clinical project deliverables, plans, and tools (e.g., essential document templates, study reference manuals, site-level tools and source worksheet/templates, Clinical Monitoring Plan (CMP), MVR template/annotations, visit letter templates).
• Review eCRF during eCRF/EDC development and support User Acceptance Testing (UAT) activities for applicable study systems.
• Identify, recruit, and recommend sites for project inclusion.
• Coordinate and lead site start-up tasks, green light/approval activities, and site activations.
• Coordinate monitoring and site management activities per CMP and applicable project requirements.
• Serve as the primary point of contact for clinical team members, providing leadership throughout the project and maintaining ongoing effective communication.
• Coordinate, facilitate, conduct, and document training for the clinical team members as required.
• Lead routine internal clinical project team meetings. Prepare agenda and minutes as required.
• Oversee clinical monitoring schedule per applicable budget, timeline, and CMP.
• Review MVRs and collected/submitted visit documentation for content, quality, and timely submission.
• Ensure proper documentation of protocol deviations and safety issues.
• Ensure compliance with applicable requirements (e.g., CMP, MVR annotation, eTMF Plan).
• Serve as a back-up resource for site visits as needed.
• Perform monitoring oversight visits as appropriate.
• Collaborate with the PM and clinical team members for creation of study updates or site mass communication (e.g., CORE blast).
• Ensure effective CAPA for identified clinical monitoring and site management compliance issues.
• Provide timely and actionable performance management feedback to applicable MedTrials functional area managers for assigned project team members.
• Coordinate and support periodic QC of eTMF, as necessary.
• Assess site performance and satisfaction.
• Prioritize project demands and make critical project decisions to ensure project success.
• Write, proofread, and/or edit documents of all types related to clinical research.
• Provide support toward the long-term success of MedTrials through key participation in bid defenses and industry training.
• Identify and communicate pertinent industry information (regulatory, marketing, technical, and other relevant) to colleagues.

Qualifications

• A Bachelor’s degree, preferably in science or a health-related field, with at least 5 years of clinical research experience is highly preferred; however, a combination of education, training, and experience will be considered.
• Minimum of 3 years of monitoring or site management experience required; CRA certification preferred.
• Experience as a Project Lead preferred.
• Excellent communication skills (verbal/written/presentation).
• Exceptional organizational, time management, problem solving, and leadership skills.
• Strong knowledge of requirements for medical product development, US federal regulations, ICH Guidelines, and GCP.
• Commitment to quality and excellence.
• Computer proficiency, including use of standard software (word processing, spreadsheet, graphics, databases, and e-mail) and use of the internet.
• Ability to travel a minimum of 30%.

Company Description

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