IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
IQVIA Biotech is now hiring for Study Start-Up Team Lead. Must have lead and study start up experience.
REPORTS TO: Manager, ISSC or Designee
Responsible for the quality and regulatory compliance of Principal Investigator (PI) credential, Essential Documents (ED) and Investigator Site Files (ISF) throughout the clinical study. Perform ISSC Project Team Management activities, coordinate the efforts of ISSC Team Members and maintain clear client and internal team communication, process documentation, 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.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Organizes efforts of team members assigned to a designated project.
- Works with ISSC Management to discuss projected hours for projects and provides updates during internal team meetings
- Serves as IQVIA Biotech representative in interactions with the sponsor
- Leads start up activities and updates during weekly client teleconferences and internal team meetings.
- Serves as a team trainer and mentor as new projects are awarded.
- Manages quality and regulatory compliance among investigational sites during start up.
- Manages periodic investigator site file audits maintained at IQVIA Biotech throughout a project to ensure compliance with GCPs and IQVIA Biotech’s standard operating procedures. Communicates directly with the site personnel, as appropriate to achieve stated objectives.
- Leads the creation of Investigator Site File Review Plans.
- Manages study timelines. Documents study challenges and communicates them to the ISSC Manager, Sr. Mgr. or Associate Dir. and Project Manager.
- Leads the development of site qualification questionnaires and reviews protocols, drawing on medical knowledge and regulatory expertise to interview sites for potential involvement in studies or trials.
- Identifies out of scope activities to Project Manager and team and assures that such activities do not begin until the client provides authorization.
- Enters Investigator names in Clinical Trial Management System (CTMS)
- Creates and disseminates Confidential Disclosure Agreements (CDA)/ Questionnaires to sites and follows up accordingly to ascertain interest and to meet study timelines.
- Negotiates CDA on behalf of sponsor.
- Creates templates for regulatory documents specific to local and central Institutional Review Board (IRB) submissions. Leads in the assembly and distribution of regulatory documents to sites and or assembles and distributes regulatory documents as the need arises.
- Updates CTMS and/or assures that CTMS is updated with document collection and all communication made with site during start-up Phase.
- Collects and reviews regulatory documents for completeness and accuracy. Responsible for updating CTMS with receipt of completed documents, scanning to the shared (G) drive and submitting to the file room to be filed. Updates tracking form as required.
- Reviews Informed Consent Forms or leads this process and follows up with sites and sponsors accordingly.
- Assists sites and/or leads a team as they assist sites with local IRB submissions
- Contacts sites or assures site contacts are made as required to resolve issues before IRB submission and final review.
- Notifies Regulatory Affairs department and or assures team members notify Regulatory Affairs when initial essential documents are available for review. Works with Regulatory Department to resolve any concerns.
- Interim line management responsibilities as required
- Performs other duties as required.
- Assures that the appropriate IQVIA Biotech and/or sponsor SOPs are followed.
- Ensures all project documentation is appropriately filed per IQVIA Biotech SOPs.
- Assists ISSC Manager, Sr. Manager or Associate Dir. in identifying and generating changes in scope and notifies client of potential changes in scope.
KNOWLEDGE, SKILLS & ABILITIES:
- Demonstrated ability in the leadership of a team of individuals in the ISSC type process activities.
- 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.
- 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.
- Working knowledge of current ICH GCP guidelines and applicable regulations.
- Ability to reason independently, assess and recommend specific solutions in clinical settings, and mentor entry level ISSC staff.
MINIMUM RECRUITMENT STANDARDS:
- BS/BA/BSc, or equivalent level of education, with a minimum of 6 years direct regulatory collection and submission experience.
- Excellent verbal and written communication skills required.
- Ability to work independently, prioritize and work with a matrix team environment is essential.
- Working knowledge of Word, Excel is required.
CRITICAL JOB FUNCTIONS:
- Ability to travel
- Very limited physical effort required to perform normal job duties
This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at URL blocked - click to apply to arrange for such an accommodation.Job ID:
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