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

📌 Clinical Trial Manager (Madrid)
🏢 Linical
📍 Madrid