Study Start Up Specialist

Employer
Planet Pharma Staffing Limited
Location
Netherlands
Salary
Up to £70,000 + Benefits
Closing date
20 Sep 2020
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Summary

Under the guidance of the EU Study Start-Up Manager of Clinical Trial Logistics, this position will be responsible for conducting end-to-end site start-up from feasibility to site activation serving as the primary point of contact for the site and the study team. This includes supporting site level feasibility assessments, coordinating site identification at a country and regional level, supporting site qualification, and site start-up activities.
 

Duties and Responsibilities

  • Serve as the primary point of contact to study team on an end-to-end start-up activity
  • Participate in or lead  Study-Start-up team meetings as appropriate
  • Utilize Study Start-Up tools to track activities and develop reports
  • Oversee Feasibility activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Feasibility Questionnaires
  • Conduct site contract/budget negotiations (Confidentiality Agreement and Clinical Trial Agreements)
  • Collect essential documents from sites, tracking & review led by Document Management Team
  • Support the collection of country and site level intelligence
  • Complete, manage and/or support Ethics Committee and Regulatory Authority submissions
  • Where required, complete, manage and/or support the country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a clinical trial as appropriate.

 

Requirements

  • At least 5 years of experience in site start-up and contract management in a pharmaceutical company or in a clinical research organization.
  • BA/BS degree in Science or related field.
  • Thorough knowledge of applicable regulations, drug development, and clinical trial management procedures.
  • Strong presentation, documentation, and interpersonal skills.
  • Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and the Internet.
  • Ability to handle multiple tasks to meet deadlines, delivering high-quality work in a dynamic environment.
  • Excellent oral and written communication skills.
  • Proficient in Dutch, French, and English
  • Excellent planning and organizational skills with effective time management.
  • Excellent interpersonal skills.
  • Thorough understanding of country-level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
  • Thorough understanding of clinical research principles and processes.
  • Thorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines, and country/local regulatory requirements (preferably in Belgium, the Netherlands, and if possible also in France).
  • Goal-oriented, self-starter with proven ability to work independently;
  • Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines;
  • Comfort with ambiguity; ability to act without having the total picture.
  • Ability to proactively identify and solve problems.

Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.

Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.

We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.

Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.

Contact Us
  • 10 Greycoat Place
  • London
  • SW1P 1SB
  • GB
  • +44 203 868 1000
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