Study Start-up Lead - IQVIA Biotech

IQVIA Biotech is now hiring for a Study Start-Up Lead.

BASIC FUNCTIONS:

Responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) during start-up.   Perform SSU Project Team Management activities, coordinate the efforts of SSU 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.  A SSU Lead may be assigned to one or more start-up projects, and works independently on a project with minimal to no supervision.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Organizes efforts of team members assigned to a designated project.
• Participates in financial and/or resource forecasting, as applicable.
• Serves as IQVIA Biotech representative in interactions with the sponsor
• Liaise with Clinical Monitoring, Site Contracts, Regulatory Affairs, other interdepartmental team members and Sponsors to enable a rapid clinical trial start-up.
• 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 study timelines. Documents study challenges and communicates them to Project Manager and SSU Lead/Management.
• May provide a role in the coordination of the development of the feasibility questionnaire for a study.  Reviews the protocol, seeks expertise from applicable supporting functions (CTM, Medical, PM, Contracts, Regulatory, etc.), and finalizes draft for Sponsor review, as required.  Works with PM to obtain client approval of the study specific feasibility questionnaire, as needed.
• Identifies out of scope activities to Project Manager and team and assures that such activities do not begin until the appropriate authorization is provided.
• May creates and disseminate Confidential Disclosure Agreements (CDA)/ Questionnaires to sites and follows up accordingly to ascertain interest and to meet study timelines.
• May review CDAs on behalf of sponsor according to country and sponsor specific requirements, seeking legal/management review when required.
• Creates templates for regulatory documents specific to local and central Institutional Review Board (IRB) / ethics committee submission requirements. Leads in the assembly and distribution of regulatory documents to sites and or assembles and distributes regulatory documents as the need arises.
• Maintains up to date and accurate tracking on the start-up status for each site in applicable system(s) for the study. 
• Collects and reviews essential regulatory documents required to activate a site according to the study specific Regulatory Management Plan.
• May create, review, negotiate and customize country/site specific Informed Consent Forms (ICFs) and follows up with sites and sponsors accordingly.
• Assists sites and/or leads a team as they assist sites with local IRB/ethics committee submissions.
• Serves as IQVIA Biotech liaison with central IRBs/REBs/ECs, as applicable.
• Contacts sites directly, or through local representative (country dependent), as required to resolve issues before CEC/IRB/REB/ethics committee submission and final review.
• May prepare and negotiate Clinical Site Contracts for site locations in some countries outside of North America.
• Liaise with legal and internal team to secure authorization of site contracts.
• Coordinate document translations required for CEC/EC submissions.
• Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA), CEC and Ethics Committee (EC) submission documentation, and similar information for other related organizations, for the assigned countries.
• Distribute and track protocol amendments and IRB/ethics approvals of the amendments, as required.
• Notifies the Regulatory Advisor representative (RA-R) and/or assures team members notify the RA-R when initial essential documents are available for review. Works with the RA-R to resolve any concerns. 
• Interim line management responsibilities as required.
• Responsible for transitioning sites from SSU to File Maintenance representative.
• Update study start-up timeline tool, per IQVIA Biotech SOP.
• Participates in reviewing Safety and Regulatory management plans.
• Leads in training and development of junior staff.
• Experience of mentoring SSU staff in above activities.
• Performs other duties as required.

KNOWLEDGE, SKILLS & ABILITIES:

• Demonstrated ability in the leadership of a team of individuals in study start-up.
• Strong knowledge of Regulatory and Central/Local ethic submission processes for assigned countries.
• Knowledge of clinical research process related to study start-up 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 oversee start-up activities in multiple countries, functions, and team members.
• Current country Regulatory Intelligence knowledge.
• Excellent verbal and written communication skills required for assigned countries.

• Ability to work independently, prioritize and work with a matrix team environment is essential. 
• Working knowledge of Word, Excel is required. 
• Ability to reason independently, assess and recommend specific solutions in clinical settings, and mentor entry SSU staff.
• Ability to travel periodically if needed

PHYSICAL REQUIREMENTS:

• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time

MINIMUM RECRUITMENT STANDARDS:

• Bachelor’s degree (or equivalent), preferably in science or related field and 5 - 7 years relevant experience including 4 years of regulatory & study-start up experience
• 1 year of demonstrated leadership experience
• Equivalent combination of education, training and experience

CLASSIFICATION (US):

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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 workday_recruiting@iqvia.com to arrange for such an accommodation.