The Clinical Trial Manager (CTM) is responsible for the management and oversight of assigned duties and clinical deliverables on studies. Such duties may include developing project documents and deliverables; effectively communicating with the Project Manager (PM), Client and study team; managing and training CRAs and other study team members; administering and providing oversight of vendor and/or study budgets and time entry; ensuring that clinical metrics are met, and operational risks identified and mitigated and managing third-party clinical vendors and contract staff.
Duties and Responsibilities
Develops the Site Activation Plan and customizes study start-up documents as needed
Coordinates site identification, selection and recruitment
Oversees initial regulatory document collection and review
Oversees regulatory and ethics submission processes
Preparation and/or review of essential study documents, e.g. Monitoring Guidelines, CRF Completion Guidelines, Patient Information and Informed Consent Form, etc.
Authorizes release of Investigational Product
Coordinates site contracts and budgets negotiation and participates in the management of investigator payments
Manages project milestones (for clinical deliverables) and proactively addresses deficiencies:
Holds study team members accountable to the study timelines and Time Entry Guidelines
Provides input to the PM in preparation for Monthly Project Reviews
Attends and provides information at Client teleconferences/study team meetings
Manages CRA performance:
Delegates and oversees work for assigned CRAs
Develops the Monitoring Plan (MP), tools, and training materials
Ensures assigned CRAs receive therapeutic and project-specific training
Oversees the study monitoring visit schedule to ensure compliance with the frequency set forth in the MP
Assists the PM and line management in projecting CRA staffing needs, and managing CRA staff utilization
Reviews and approves visit reports, follow-up letters, expense reports and timesheets within the required timeframes
Schedules and manages CRA project team meetings (and meeting minutes)
Performs quality assessment visits as required
Performs remote review of clinical data within the EDC system to identify trends in enrollment and data entry issues at sites; proactively interfaces with clinical monitoring team and Client to identify solutions and to ensure the data is always consistently monitored/source data is verified at all times.
Participates in the performance appraisal process by providing timely and accurate feedback regarding the performance of assigned CRAs
In the event of a CRA change, ensures a thorough and effective handover, documenting per SOPs
When regulatory lead is not assigned, the CTM ensures regulatory documents for assigned countries are filed according to the guidelines in the Trial Master File Plan
Performs the periodic TMF QC reviews for assigned countries and sites
May participate in Vendor Management:
Manages the budget negotiation and contracting process for clinical vendors
Ensures clinical vendors meet deliverables per timeline and budget
Oversees quality of clinical vendor deliverables
Manages Project Finances:
Assists the PM in review of the study budget and expenses to ensure financial targets are met
Reports completion of project deliverables to ensure accurate revenue recognition
Reviews vendor invoices for accuracy prior to payment
Assists the PM in generating changes in scope and notifying the Client of changes, as needed
Performs monitoring of assigned sites as required
Attends and contributes to investigator meetings, Kick-Off meetings and project meetings
Assist CRAs for on-site audits if needed
Other duties as assigned
Required Skills and Abilities
Excellent written and verbal communication, presentation skills, conflict management, time management, organizational, interpersonal, and problem-solving skills
Knowledge of project management techniques and tools and proficient in project management software
Strong team-building skills and the ability to work successfully in a matrixed team environment
Excellent customer service and relationship building skills with the ability to proactively address and prioritize expectations
Excellent working knowledge of ICH, GCP and local guidelines/regulations
Knowledgeable in all aspects of clinical trial conduct, including systems, study financials and procedures
Ability to prioritize and manage multiple tasks, and to delegate responsibility as necessary
Dedication to quality in all work tasks and deliverables
Working knowledge of computer systems, applications and operating systems
Education and Experience:
Life Science degree, nursing background and/or combination of education / experience
Requires a minimum of three years of clinical trial management experience
Previous experience in personnel management preferred
Previous experience as a CRA preferred
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