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