Deutschland - Clinical Team Leader/ Senior

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The Clinical Team Leader serves as the Lead CRA (LCRA) with full responsibilities for clinical monitoring and line management ofClinical Research Associates (CRAs). They ensure appropriate communication, regulatory documentation, and ongoingoversight of projects and provide support for business development. Core Responsibilities 1. Communication - Keeps project leadership apprised of team issues, seeking guidance as needed.  Maintains timely and effective communication among team members and site staff.  Attends Kick-Off, Quick Start, and Investigator meetings.2. Regulatory Documentation - Independently resolves protocol questions with the Project Manager (PM) and patient related issues with the Medical Monitor (MM).  Maintains a record of all contacts with the PM or MM concerning protocol deviations and clarifications.3. Monitoring - Develops clinical plans and guidelines, including clinical monitoring plans.  Assures compliance with monitoring intervals according to the project requirements.  Typically acts as LCRA on studies.4. Monitoring and Oversight - Reviews the study scope of work, budget, and protocol content.  Provides training to project teams on protocol, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelin ...

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