CRA Line Manager - Leipzig, Deutschland - Meet

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    Meet Leipzig, Deutschland

    vor 2 Wochen

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    Beschreibung

    The Organisation: Our client is a key player in the MedTech sector, operating as an innovative medical device business within the larger framework of a renowned organization. The organisation stands out with a team of over 2,000 employees and a reputation as one of the fastest-growing entities in medical technology.

    The Role: CRA Line Manager will oversee, grow, and develop our in-house and remote Lead Clinical Research Associates (CRAs), Clinical Research Associates (CRAs), and Clinical Trial Associates (CTCs). Responsibilities include managing site and vendor matters in collaboration with Clinical Program Managers, under the supervision of the Assoc. Dir, Clinical Affairs and Programs, EMEA & APAC. This role entails training, managing, and developing CRAs and CTCs to ensure the controlled, compliant execution of clinical trials, prioritizing subject safety, privacy, and maintaining the highest level of data quality and integrity.

    Requirements:

    • BS degree in biological sciences or related medical/scientific field.
    • 8+ years of direct clinical research experience, with at least 3 years directly managing CRAs.
    • Previous experience as a (Lead) Clinical Research Associate.
    • Expertise in GCP and regulatory compliance guidelines for clinical trials.
    • Strong attention to detail, accuracy, prioritization, organizational skills, and excellent cross-functional team leadership.
    • Ability to write and edit technical documents such as protocols, protocol amendments, informed consent, and other trial-related documents.
    • Experience managing the operation of clinical studies of Class Ill cardiovascular devices is strongly preferred.
    • Proficiency with computer programs, including the Microsoft Office suite and Microsoft Project.
    • Travel up to 30% of the time; the position is field-based with regular monthly trips to Headquarters.

    Key Responsibilities:

    • Lead recruitment, training, and retention of a diverse group of in-house and remote CRAs/CTCs.
    • Ensure adherence to regulations through site visits, EDC system metric reviews, Trial Master File assessments, monitoring reports, and effective communication.
    • Develop direct reports through performance reviews, mentoring, and coaching.
    • Establish and maintain CRA metrics using the Clinical Trial Management System (CTMS).
    • Collaborate with Clinical Program Managers to identify training needs and refine processes affecting CRA conduct.
    • Work closely with Clinical Program Managers to ensure appropriate resourcing for monitoring and study support.
    • Develop and implement training programs for new clinical research staff and provide ongoing education and mentorship to experienced staff.
    • Support CRAs/CTCs through the study start-up process, ensuring timely review of documentation, including budgets, clinical research agreements, and informed consents.
    • Ensure inspection readiness activities and perform Trial Master File (TMF) site audits regularly.
    • Collaborate with the Clinical Program Manager to ensure proper development, review, and implementation of Corrective and Preventive Actions (CAPAs).