Job Overview

Under the guidance of Global Clinical Study Support (“CSS”) management, this position will be responsible for review, coordination and finalization of Global Informed Consent Form templates for all sponsor clinical studies that are managed by Development Operations.

It could be possible to include also to 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. May also include maintenance activities.

Essential Functions

Master ICFs: The reviewer checks the ICF created by the study team against the protocol, the biological samples plan, and other documents to confirm accuracy.
Country ICFs: These are either Master ICFs adapted to the country by the CROs, or national country templates adapted to Incyte standards by the CROs. The reviewer checks them for accuracy against the Master.
RFIs/EC queries: The reviewer reviews RFIs and updates the ICFs to address them. To work with other departments for input, but a solid knowledge base in how to resolve these queries independently is key.
Responsible for tracking progress of Informed Consent Form template language reviews and escalations.
Co-manages maintenance of the centralized Informed Consent Form mailbox.

In addition, it could be possible to include:

Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.

Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.

Distribute completed documents to sites and internal project team members.
Prepare site regulatory documents, reviewing for completeness and accuracy.
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
Review and provide feedback to management on site performance metrics.
Review, establish and agree on project planning and project timelines.

Ensure monitoring measures are in place and implement contingency plan as needed.
Inform team members of completion of regulatory and contractual documents for individual sites.
Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
Perform quality control of documents provided by sites.
May have direct contact with sponsors on specific initiatives.

Qualifications

Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
At least 2 years of ICF reviews, experience in reviewing all countries, but EU is a must.
EU/EEA knowledge, specifically experience reviewing ICFs before and after EU submissions.
Knowledge of CTIS. We don’t submit anything in CTIS ourselves but understanding how the submission process works and being able to check access system to review timelines RFI, etc. is helpful.
Reviewing ICFs for countries outside of Europe.
Any AI knowledge- we use-Copilot
In-depth knowledge of clinical systems, procedures, and corporate standards.
Good negotiating and communication skills with ability to challenge, if applicable.
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
Understanding of regulated clinical trial environment and knowledge of drug development process.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.