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Initiation Clinical Site Manager I

Employer
Parexel
Location
Amsterdam, Netherlands
Salary
Competitive
Start date
9 Nov 2019
Closing date
9 Dec 2019

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

The Initiation Clinical Site Manager I (ICSM I) is responsible for conducting and facilitating 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.

This role in office-based in Amsterdam.

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 (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

    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.

    Education:
  • 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).

    If you are ready to join PAREXEL's Journey, please apply!

    • Company

    parexel

    When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart™.

    How to describe Parexel’s culture in one word: 

    Henry

     

     

    Working With Heart™ - Christina's perspective:

    Working With Heart™ - Christina's perspective:

     

    Careers Blog | Our Culture | Diversity, Equity & Inclusion | Benefits | Our Hiring Process

    Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. 

    Company info
    Website
    Telephone
    +44 1895 238000
    Location
    The Quays
    101-105 Oxford Road
     Uxbridge
    Middx
    UB8 1LZ
    United Kingdom
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