Clinical Trial Operations Opportunities at Parexel
Clinical Trial Operations
Senior initiation Clinical Site ManagerJob ID 54425BR Milan, Lombardy, Italy
The main responsibility of the Senior Initiation Clinical Site Manager is managing the entire Clinical Site Agreement (CSA)
process for a number projects, including the development of the study specific CSA strategy with the Sponsor,
preparation of the corresponding country specific CSA templates and country specific budgets and also
negotiation of such CSAs and budgets with the individual sites located in his/her region/country.
Further, the responsibilities include managing CSA activities and liaising with PL, COL and the Sponsor to ensure that the CSA start-up deliverables are met.
• 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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