Manager, Study Start -Up (Home-Based) - IQVIA Biotech

IQVIA is now hiring for a Manager, Study Start - Up. This can be either home-based or office based in Morrisville, NC.

BASIC FUNCTIONS:

Responsible for the quality and regulatory compliance of the Principal Investigator (PI) credentialing, Essential Documents (ED) during study start-up and Investigator Site Files (ISF) during start-up.   Perform SSU project team and line management activities, coordinate the efforts of SSU Team Members and maintain clear client and internal team communication.  Oversee process documentation in compliance with International Congress on Harmonization-Good Clinical Practice (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Responsible for direct line management for Local Study Start-up team members including resource management, selection and hiring, performance training and oversight, timesheet review and approval and team collaboration and motivation activities.
• Liaise with Clinical Monitoring, Site Contracts, Regulatory Affairs, other interdepartmental team members and sponsors to enable a rapid clinical trial start-up.
• Leads SSU activities and updates during weekly client teleconferences and internal team meetings as needed.
• May lead the development of site qualification questionnaires and protocol review, drawing on medical knowledge and regulatory expertise, to interview sites for potential involvement in studies or trials.
• May direct the creation and dissemination of Confidential Disclosure Agreements (CDAs) and Feasibility Questionnaires to sites and follow up accordingly to determine interest and to meet study timelines.
• May negotiate the CDA on behalf of sponsor according to country requirements.
• May create, review, negotiate and customize country/site specific Informed Consent Forms (ICFs) and follows up with sites and sponsors accordingly.
• Leads a team as they assist sites with local IRB/ethics committee submissions
• Supports a team that interacts with central IRBs/REBs/ECs, as applicable.
• Leads the SSU team in creation of templates for regulatory documents specific to local and central Institutional Review Board (IRB) / ethics committee submissions. Oversees/leads in the assembly and distribution of regulatory documents to sites and/or assembles and distributes regulatory documents as the need arises.
• Assures team members notify Regulatory Advisor representative (RA-R) when initial essential documents are available for review. Works with RA-R/team to resolve any concerns including addressing trends across the study. 
• Manages quality and regulatory compliance documentation among investigational sites and team.
• Manages study timelines, documents study challenges and communicates them to the, Sr. Manager or Associate Director and Project Manager.
• Assures team members maintain up to date and accurate tracking on the start-up status for each site in applicable system(s) for the study. 
• Oversee collection and review of regulatory documents for completeness and accuracy.
• Supports team with translations required for CEC/EC submissions and guidance as needed for CEC/IRB/REB/EC process
• Assures team members understand budgets for the studies they are working on and maintain accountable for notifying Project Managers when additional activities may cause the overage on budgets.
• Maintains contact with Project Managers, Clinical Trial Managers and CRAs to obtain necessary documentation throughout study start-up.
• Assures that the appropriate IQVIA Biotech and/or sponsor SOPs are followed.
• Assures all project documentation is appropriately filed per IQVIA Biotech SOPs.
• Assures that any out of scope SSU activities are alerted to SSU Management, Project Manager and team and assures that such activities do not begin until the appropriate authorization is provided.
• Assists Sr. Manager or Associate Director in generating changes in scope within the SSU activities.
• Participates in financial and/or resource forecasting.
• Leads and reviews the Regulatory Document Management Plans.
• Serves as IQVIA Biotech representative in interactions with the sponsor, as appropriate.
• Oversees team transitioning sites from SSU to File Maintenance Associates.
• Participates in proposal preparation and bid defense activities as requested.
• Serves as a team trainer and mentor as new projects are awarded.
• Trains and mentors new employees in the implementation of the tasks and responsibilities within their job description.
• Serves as backup to Sr. Manager/Associate Director as requested.
• 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 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 SSU staff.
• Ability to oversee start-up activities in multiple countries, functions, and team members.
• Previous line management required.
• 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 and Excel is required.
• Ability to travel periodically if needed

MINIMUM RECRUITMENT STANDARDS:

• BS/BA/BSc, (or equivalent), preferably in science of related field plus 7 years of related clinical research experience
• 2-3 years of experience in a project leadership capacity, line management experience preferred
• 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.