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Job Description:

Job Title:            Clinical Trial Manager II (CTM II)

Job Location:     Remote (homebased)

 

Job Overview:  

The Clinical Trial Manager II is responsible for the day to day leadership and management of monitoring services for clinical projects, including direct communication and interaction with investigative sites, Clinical Research Associates (CRAs), and the project Sponsor.  This position ensures the on time and high quality delivery of: project specific on-site and remote monitoring services; accountability for clinical monitoring team training compliance; tracking of critical project tasks; strategic and tactical study enrollment support including, project-specific enrollment planning; and project accountability for CRA utilization.

 

Job Duties and Responsibilities:

Ensure project consistency within and across assigned projects by following Caidya and/or sponsor SOPs, guidelines, and plan documents. Create and manage the Clinical Monitoring Plan (CMP), including regular review (annual at minimum) and updates to the plan. Review and provide input to the Project Manager (PM) on the Project Management Plan (PMP). Timely CRA trip report review, management, resolution, and escalation.  Includes tracking of trip report packet (confirmation letter, report, follow up letter) submissions. Timely review of protocol deviations, action items and frequently asked questions. Track and escalate items as appropriate. Oversee clinical portion of the Trial Master File (TMF) and conduct periodic review for completeness. Responsible for ongoing analysis of enrollment activities/trends and escalation/mitigation to PM/Sponsor as appropriate.  Develops strategic and tactical plans for ensuring enrollment targets are met. Develop study newsletter. Responsible for project resource projections and ensure appropriate CRA staffing.  Remove CRAs through planned attrition according to study timelines and budget projections. Responsible for assuring the quality of the clinical monitoring deliverables and for identifying and mitigating risks. Manage monitoring team site assignment and visit schedules to ensure CMP metrics are maintained. Oversee CRAs to complete remote site management activities. Conduct project co-monitoring visits and team training for assuring the quality of the clinical monitoring deliverables and for identifying and mitigating risks. Provide coaching/mentoring to the monitoring team. Develop project specific training materials for study team. Provide project-specific performance feedback to CRA team, PM, and Line Management.    Conduct internal team calls and Sponsor calls (as needed). Serve as site/CRA contact for protocol clarifications and subject enrollment. Serve as Sponsor contact for monitoring/site issues. Relate project status and issues to CRAs and PM weekly at minimum. Responsible for coordination and management of the clinical monitoring budget and scope of work for monitoring activities. Assist the PM with coordination and management of the project budget, grant administration and project invoicing. May review and approve weekly project labor and pass through expenses for CRAs. Track monitoring services billing units and report to Project Manager monthly. Make updates to study specific CTMS and/or project working files as appropriate. Participate in monthly project review meetings and provide budget projections for monitoring service units. Monitor and plan for resolution of data backlog by working with clinical management. Collaborate with Lead Data Manager to develop CRF Completion Guidelines and edit specifications. Deliver Clinical Monitoring portion of a bid defense presentation. Support in the development of working relationships with regulatory authority and IRB/IEC personnel within the constraints of any local guidelines and regulations. Attend project and department meetings. Complete weekly time and expense entry. Maintain good standing with internal training requirements. May assume CRA duties and responsibilities when needed. Conduct other activities as needed for a given project.

Supervisory Responsibilities:

Provides project work direction to regional/office based CRAs, Internal Clinical Research Associates (ICRAs) and CTAs.

Job Requirements:

Education College degree desired, preferably with a healthcare or life science degree or equivalent experience Experience 4 + years of Clinical Research Associate (CRA) experience or equivalent preferred. 2-4 years Clinical Trial Manager (CTM) experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the role. Specific therapeutic experience may be required (e.g. infectious disease, oncology, etc.) Skills/Competencies Strong written and verbal communication skills Able to analyze information, set strategy and follow plan through completion Foster active exchange of information and ideas Strong interpersonal skills; ability to establish and maintain strong and harmonious relationships with both internal and external customers Represents the company externally as Caidya brand ambassador Expert monitoring skills to independently conduct all types of site monitoring visits Exceptional computer skills and the ability to work across multiple technologies Strong presentation skills Comprehensive knowledge of GCP/ICH guidelines Proficiency in medical terminology Able to exercise judgment within defined procedures and practices and to determine appropriate action independently. Exceptional attention to detail Superior problem-solving skills Works successfully in a matrix environment Ability to manage multiple vendors Management of global studies preferred Exceptional time management and organizational skills Good documentation skills Capabilities Ability to work remotely, if required. Valid passport required in the case of international business travel. Between 10% to 20% travel, as needed.

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