Clinical Trial Operations Opportunities at Parexel
Clinical Trial Operations
Senior Initiation Clinical Site ManagerJob ID 52201BR Paris, Île-de-France Region, France
Conduct and facilitate specific start-up activities such as feasibility, site identification, pre- qualification, Site Regulatory Package (SRP) review and approval, Informed Consent (ICF) customization, IRB/IEC application preparation and submission, in accordance with relevant regulations, SOPs, and study specific procedures.
• Conduct country specific feasibility and/or site pre-qualification.
• Review and validate site identification list.
• Collect and negotiate Confidentially Agreements (CDA) as required.
• Organize translations per country/regulatory/client requirements.
• Review and approve country specific and/or site specific documents or essential regulatory documents (SRP).
• Customize, review, configure, and negotiate as required country/site specific Informed Consent Forms (ICF) and their amendments.
• Prepare and submit IRB/IEC application and follow up until final approval received (initial submission and amendments).
• Prepare and negotiate as required initial and/or amended CSA at a site level.
• Resolve CSA changes requested by the site and approve any change in CSA language with support from Site Contract Leader (SCL) as required.
• Collect internal CSA signatures.
• Complete routine departmental administrative tasks in an accurate and timely manner (e.g. timesheets, metrics, etc.).
• Proactively keep manager informed about work progress and any issues (including conflicting priorities and free capacity).
• Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL training requirements, and study specific procedures and training.
• Ensure basic understanding of project scope, milestones, budgets, and time codes and strive for high quality, timely, and efficient delivery.
• Update all appropriate Clinical Trial Management Systems (CTMS) as indicated per function on an ongoing basis and submit all relevant documents to central files per the Central File Maintenance Plan.
• Escalate any site and study issues that require immediate action to the Functional Lead (FL).
• Proactively work with other project team members to meet project goals.
• Show commitment and perform consistent high quality work
• Client focused approach to work.
• Ability to interact professionally with external customers.
• Ability to manage multiple and varied tasks with enthusiasm.
• Attention to detail.
• Willingness to work in a matrix and virtual team environment and to value the importance of teamwork.
• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic .Document Management System (EDMS), and MS- Office products such as Excel and Word.
• Sound interpersonal, verbal, and written communication skills.
• Sound problem solving skills.
• Sense of urgency in completing assigned tasks.
• Effective time management in order to meet daily metrics, team objectives, and department goals.
• Developing ability to work across cultures.
• Ability to influence and negotiate resolutions and outcomes with sites and IRBs/IECs.
• Willing and able to travel locally and internationally occasionally as required.
• Educated to degree level (biological science, pharmacy, or other health-related discipline preferred).
• Proficient in written and oral English and fluent in local language.
Minimum Work Experience:
• Previous documented relevant work experience in clinical research (Site Management experience, Start Up experience).
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