Join us in our exciting journey!

We currently require a motivated and enthusiastic clinical trials professional to join our rapidly growing international division as a Clinical Trials Coordinator.

Our client is one of the TOP 5 pharmaceutical companies who is dedicated and passionate about improving the lives of patients across several therapeutic areas.

Description of Roles and Responsibilities

Trial and site administration:

• Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and trackers o Clinical supply & non-clinical supply management, in collaboration with other country roles
• Manage Labeling requirements and coordinate/sign translation change request

Document management:

• Prepare documents and correspondence o Collate, distribute/ship, and archive clinical documents
• Assist with eTMF reconciliation
• Updating manuals/documents (e.g., patient diaries, instructions)
• Document proper destruction of clinical supplies.
• Prepare Investigator trial file binders o Execute eTMF Quality Control Plan
• Obtain translations of documents

Regulatory & Site Start-Up responsibilities:

• In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
• Obtain, track and update study insurance certificates
• Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
• Publish study results for GCTO and RA where required per local legislation

Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for:

• Develop country and site budgets (including Split site budget)
• Tracking, and reporting of negotiations
• Maintenance of tracking tools o Contract development, negotiation, approval and maintenance (e.g. CTRAs)
• Update and maintain contract templates (in cooperation with Legal Department)
• Payment calculation and execution (investigators, vendors, grants)
• Ensure compliance with financial procedures
• Monitor and track adherence and disclosures,
• Budget closeout.

Meeting Planning:

• Organize meetings (create & track study memos/letters/protocols)
• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable

Experience Required

• Minimum 1-2 years as Studdy Coordinator/CTA or relevant healthcare experience
• B.A./B.S. (Life Science preferred) or equivalent healthcare experience

CORE Competency Expectations

• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands on knowledge of Good Documentation Practices
• Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
• ICH-GCP Knowledge appropriate to role Behavioral Competency Expectations
• Effective time management, organizational and interpersonal skills, conflict management
• Effective communication with external customers (e.g. sites and investigators)
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus.
• Able to work independently
• Proactive attitude to solving problems / proposing solutions

Are you interested or do you know the ideal candidate?

• If you know the right candidate or for more information on this role please contact daria.shuvaeva@iqvia.com
• Please note is necessary that your application is registered in our Talent Network to process your candidacy.

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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com