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. The CTM will ensure that the conduct of the clinical portion of the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and with any applicable regulatory requirements in the assigned countries. Generally, CTM staff function under the guidance of the PM for their respective projects. However, CTMs may be responsible for managing individual studies based on the scope of work. CTMs may also provide input into new business proposals and participate in bid defense meetings.

Senior CTMs will generally be responsible for working on larger, more complex studies/programs/global studies, mentoring CTM I staff, and contributing to department training initiatives. Senior CTM staff may be delegated additional duties by a PM, including, but not limited to, direct responsibility for vendor management tasks and project financial management.

The CTM reports to the Manager of Clinical Trial Management, WR and/or Director, Study Start-Up in the US.

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