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initiation Clinical Site Manager II

Employer
Parexel
Location
Berlin, Germany
Salary
Competitive
Start date
17 Oct 2019
Closing date
23 Oct 2019

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

The Initiation Clinical Site Manager"(iCSM) is specializing in Pre SIV activities and will be accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study.

The iCSM acts as PAREXEL's direct point of contact with assigned sites, and is accountable for quality and delivery during the start-up phase.

  • Build relationships with investigators and site staff.
  • Conduct, drive and manage country specific feasibility and/or site prequalification and qualification activities, which may include:
    • Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
    • Conduct remote Qualification Visits (QVs).
  • Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
  • Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific
    documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
  • Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters
    of country/regulatory/client requirements), and customize and negotiate any amendments.
  • Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until
    receipt of final approval.
  • Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
  • Forecast, develop, manage, and revise plans and strategies for:
    • IRB/IEC and MoH / RA submission/approval,
    • Site activation
    • Patient recruitment & retention.
  • Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
  • Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but
    not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in
    training, data quality or integrity, study non-compliance, etc.
  • Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific
    training requirements prior to study start.

    Qualifications

    • Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
    • Able to work independently
    • Client focused approach to work
    • Ability to interact professionally within a client organization with the support of manager or CSMⅡ/Ⅲ
    • Flexible attitude with respect to work assignments and new learning.
    • Ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply understanding of study protocol(s).
    • Willingness to work in a matrix environment and to value the importance of teamwork.
    • Sound interpersonal, verbal, and written communication skills.
    • Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables,
    • Developing ability for effective time management in order to meet study needs, team objectives, and department goals
    • Developing ability to work across cultures
    • Shows commitment to and performs consistently high quality work
    • Ability to successfully work in a ('virtual') team environment
  • Company

    Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

     

    Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

     

    Company info
    Website
    Telephone
    +44 1895 238000
    Location
    The Quays
    101-105 Oxford Road
    Uxbridge
    Middx
    UB8 1LZ
    GB

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