Senior Site Activation Specialist (contract Specialist)

Senior Site Activation Coordinator (Contract Specialist)

Country Site Activation

Join us on our exciting journey!

IQVIA’s Country Site Activation team are a global network who identify and activate sites to the highest quality to ensure patients on Clinical trials have access to safe and effective medication. We are leaders in innovation and first to new technologies meaning a vast amount of career development opportunities are available.

Our (Senior) Site Activation Specialists perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. You may also be involved in maintenance activities

Job Overview:

Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed

Ensures the successful negotiation and on-going management of clinical trial agreements (CTA)  with investigative sites and investigators.

Works cross functionally with Clinical and RSU Team in support of timely site start up for the conduct of clinical trials including accurate forecast of contract execution timelines.

Reviews and negotiates budgets for CTA based on the calculation provided by the Sponsor.

Communicates and explains legal/ budgetary issues to internal and external parties per project guidelines.

Prepares and concludes amendments to CTA based on client requested contract changes and based upon study CTA guidelines.

Appraises contracts for completeness and accuracy and ensures adherence to department guidelines; corrects documents and files changes to contracts (QC process).

Requirements:

• Bachelor’s Degree in Life Science or related field
• Minimum 3 years’ prior experience in life sciences or similar.
• Fluent/ native language capabilities, including English
• Makes recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area
• Makes recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area
• Ability to handle change and ambiguity
• Ability to work on multiple projects
• Applicants will ideally have knowledge of applicable functional/regulatory requirements, including local regulations, SOPs and GCP/ICH

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