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Clinical Trial Operations Opportunities at Parexel

Clinical Trial Operations

initiation Clinical Site Manager II

Job ID 55150BR Berlin, Land Berlin, Germany
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

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