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Clinical Team Leader (CTL) - Bucharest, Romania - Oferta z Jobs.pl

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Clinical Team Leader (CTL) - Bucharest, Romania

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  • Role: Clinical Team Leader (CTL)

    Location: Office Based - Bucharest, Romania

    Job Type: Permanent

    Key Responsibilities:

    Manage the study start up in collaboration with PM and Regulatory Lead
    Coordination and oversight of Critical documentation
    Preparing Monitoring Plan
    Modifying visit reports according to study specific requirements
    Selection of investigators and sites; SEV report review and approval
    Site initiation management; SIV report review and approval
    Monitoring Visit Report (MVR) review, management, resolution and escalation.
    Responsible for timelines, budget and quality of Clinical Monitoring team deliverables, identification of risks and issues and escalating to PM.
    Coordinate and manage site visit schedules
    Develop patient recruitment and retention plans
    Review and approves WTS time reporting.
    Completing clinical part of Project Review Form and provide information about planned activities to PM to complete the Progression Charts
    Manages CRA site assignments and schedules.
    Conducts project co-monitoring, assessment visits and team training.
    Site contact for protocol clarifications and subject enrollment if CRA unavailable.
    Protocol deviation documentation, tracking and escalation.
    Oversees the development of study newsletters communication.
    Relays project status and issues to PM.
    Ensures appropriate CRA staffing and resources.
    Assists, where appropriate, the PM in discussions with clients on study documentation issues or technical related documentation concerns that may arise.
    Oversight of CTMS updates
    Coaches/mentors CRA team.
    Develops project-specific training materials for team.
    Assists and supports in the preparation of study specific training matrix and various training material used by Pharm-Olam
    Manages Investigator and Site Payments
    May provide line management to CRAs (Europe).
    May be assigned to monitor 1-2 sites.

    Working Relationship:

    Reports to the Senior Clinical Research Manager, Clinical Operations Manager, Associate Director of Clinical management or designee.
    Collaborates with Project Management, Clinical Research Managers, QA and other Pharm-Olam departments.
    Liaise with clients as requested by the PM.

    Education Requirements and Qualifications:

    A degree in life science or nursing qualification (preferred but not required)
    At least 6 years minimum experience with at least 1 year as a Lead/Senior CRA with leadership experience.
    Ability to mentor and train other CRAs in a positive and effective manner.
    In-depth knowledge of clinical trials and the critical elements for success in clinical trials.
    Strong therapeutic background.
    Possesses experience and knowledge in the CRO industry that will support Pharm-Olam's management of clinical trials.
    Demonstrates the ability to successfully manage people/project issues.
    Mature management skills demonstrated by calm and thorough review of situations. Proactively identifies and addresses problems. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolutions.
    Demonstrates the ability to define and meet project requirements.
    Demonstrates flexibility for improvement and creating solutions.
    Proven organizational abilities, and excellent written and oral communication skills.
    Excellent team player with team building skills.
    Strong customer focus


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