• Senior initiation Clinical Site Manager Jobs in Italy

  • PAREXEL International Ltd
  • Italy

Job Description:

Essential Function

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

Key Accountabilities
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 (eg 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
Qualifications Skills
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)
Language Skills
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)

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Biotechnology/Pharmaceutical/Medicine
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 15th Mar 2020

Key Skills:

Company Profile:

PAREXEL International Ltdarfix

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