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Clinical Trial Operations Opportunities at PAREXEL

Clinical Trial Operations

initiation Clinical Site Manager I

Job ID 50538BR Shanghai, Shanghai Municipality, China
Act as PAREXEL’s direct point of contact with assigned sites, 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:
o Preparation, negotiation, and facilitation of execution of
Confidentiality Agreements (CDA), Clinical Site Agreements
(CSAs) and any amendments.
o 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:
o IRB/IEC and MoH / RA submission/approval,
o Site activation,
o 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.
• Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.
• Work in a self-driven capacity, with limited need for oversight.
• Proactively keep manager informed about work progress and any issues.

Qualifications

Previous relevant work experience preferred.
Educated to degree level (biological science, pharmacy, or other health-related discipline
preferred) or equivalent nursing qualification or other equivalent experience.

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