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