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 #J-18808-Ljbffr

📌 Clinical Trial Manager (Madrid)
🏢 Linical
📍 Madrid