IQVIA Biotech is a unique division specialising in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced working environment. The sector we are in is cutting edge for therapies with un-met medical need.
Responsible for the quality and regulatory compliance of Investigator Site Files (ISF) during the file maintenance period of the study. Work with both internal and external teams to assure good communication regarding documentation processing. Assure documents maintained for a study are in compliance with International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients.
A Senior Site File Specialist will work in conjunction with or under the supervision of a Lead and/or Manager. Senior Site File Specialist may be assigned to support start-up projects, as needed.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Manages ongoing IRB/ethics continuing renewals, where applicable, and reviews investigator study files for expired documents.
- Communicates directly with the site, with the Site File Associates/Specialists, or local CRAs in various countries, to obtain corrections to incomplete/incorrect/expired documents. May tracks any action items to CRAs/sites in CTMS.
- Oversees the Site File Associates/Specialists on projects(s) as needed.
- Reviews eTMF reports on a regular basis to ensure all documents have been filed according to IQVIA Biotech SOPs.
- Ensures Periodic Site File Reviews are completed as per the IQVIA Biotech SOPs.
- May review documents received from sites, IRBs and CRAs to ensure compliance with GCP and IQVIA Biotech's standard operating procedures from maintenance through close-out phase
- May be involved in the distribution and tracking of protocol amendments and IRB/ethics approvals of the amendments, as required.
- In NA, supports the review of site specific ICFs as changes occur during the study. Completes ICF checklists and files IRB approved ICFs throughout the study. Maintains accurate and complete site specific ICF template tracking.
- Distributes reportable expedited safety reports and cross reports to sites, as needed, and tracks and files reports in appropriate system(s).
- Submit ongoing regulatory documents to clients as needed.
- Follows the appropriate IQVIA Biotech and/or sponsor SOPs during conduct of the study.
- Ensures all project documentation is appropriately filed per IQVIA Biotech SOPs, or Sponsor SOPs if required.
- Provides updates to Manager and/or PM on a regular basis, and communicates any out of scope activities.
- Adheres to study timelines, document/escalate study challenges and communicates update to PM/ Manager.
- Responsible for creating study specific template documents, per IQVIA Biotech SOP.
- Identifies out of scope activities to Management, Project Manager and team and assures that such activities do not begin until the client provides authorization.
- Assures that team members understand budgets for the studies they are working on and are accountable for maintaining project activities within documented scope and budget.
- Attends Client meetings and audits as needed
- May operate as a Regional lead for studies, as applicable
- For NA only, serve as IQVIA Biotech liaison with Central IRBs and performs submission to Central IRB.
- Mentors junior staff.
- Participates in financial and/or resource forecasting, as applicable.
- Performs other duties as required.
KNOWLEDGE, SKILLS & ABILITIES:
- Knowledge of clinical research process and medical terminology
- Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members
- Excellent organizational and interpersonal skills with track record for attention to detail.
- Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
- Ability to manage multiple competing priorities within various clinical trials
- Extensive knowledge of current ICH GCP guidelines and applicable regulations
- Working knowledge of audit preparation
- Ability to gain successful outcomes in areas of challenge regarding the TMF & document management
- Ability to lead and/or oversee junior level staff in above activities.
- Ability to work independently, prioritize and work with a matrix team environment is essential.
- Working knowledge of Word, Excel is required.
At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.