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Senior Clinical Trial Transparency Associate

Employer
ICON Strategic Solutions
Location
Hungary, Poland
Salary
Competitive
Start date
7 Jun 2024
Closing date
6 Jul 2024

Job Details

Senior Clinical Trial Transparency Associate is responsible for CTT deliverables, the role is single sponsor dedicated.

The role can be based in Eastern Europe

Responsibilities:

Supporting Clinical Trial Transparency deliverables, in cooperation with senior CTT Team members

  • Create and support numerous CTT deliverables including, but not limited to clinical trial disclosure to registries, redactions, results summaries, etc. in liaison with cross functional teams under limited supervision of senior CTT team members
  • Assess document requirements, gauge document complexity, and identify information gaps or issues.
  • Produce high quality, accurate, and fit-for-purpose documents
  • Takes initiative and creativity in solving routine problems that affect multiple documents; ensures consistency between related documents
  • Provide project teams with expertise and strategic guidance on analysis and presentation of CTT data and documents
  • Takes initiative and creativity in solving routine problems that affect multiple documents; ensures consistency between related documents
  • Systematically review and/or perform quality control checks of CTT deliverables prepared by junior CTT team members against pre specified check lists and requirements


Working knowledge of transparency related FDA, EMA and other global regulations, ICH guidelines, Good Clinical Practices, the drug development process, MedDRA and regulatory requirements.
  • Ability to write and review CTT specific documents under supervision.
  • 3-5 years of experience in Clinical Trial Transparency area

Experience and technical skills within Clinical Trial Transparency, as a part of a pharmaceutical company or CRO would be an advantage.
  • Process and project management skills; ability to multitask while driving towards critical deadlines on all projects.
  • Good interpersonal skills and the ability to work within a team in collaborative and supportive role
  • Fluent in English (oral and written)

Company

As the largest global provider of Functional Service Provision (FSP) with over 90 partnerships and 14,000+ employees, we have deployed FSP solutions across all major functions, from clinical monitoring and project management through data management, statistical programming, and beyond.

ICON Strategic Solutions teams are embedded in our clients' businesses, working as a dedicated resource within some of the world’s leading Pharmaceutical & Biotech companies. You will play a key role in helping to deliver cutting-edge research, working on novel therapies that deliver real impact.

Why choose a career with ICON Strategic Solutions?

Meaningful Work: You’ll contribute to cutting-edge projects that have a real impact on global healthcare. Your work will play a pivotal role in shaping the future of medicine and improving patient lives.

Collaborative Environment: We foster a collaborative and inclusive work culture that thrives on teamwork, diversity, and knowledge sharing. You'll have the opportunity to collaborate with industry-leading experts, learning from their experiences and growing both professionally and personally.

Innovative Technologies: At ICON Strategic Solutions, we embrace the latest technologies and tools to enhance our capabilities. You'll have access to state-of-the-art software and resources, empowering you to deliver high-quality results efficiently.

Career Growth: We value our employees and invest in their professional development. You'll have access to comprehensive training programs, mentorship opportunities, and a clear career progression path. We believe in recognizing and rewarding exceptional performance, providing ample scope for advancement within the organization.

Global Reach: Joining ICON Strategic Solutions means being part of a truly global company. With service capabilities in 92 countries, you'll have the chance to collaborate with colleagues from diverse backgrounds and gain exposure to projects with a global reach.

Company info
Website

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