Manager, Site Feasibility (Home-Based) - IQVIA Biotech

IQVIA Biotech is now hiring for a Manager, Site Feasibility.

BASIC FUNCTIONS:

Responsible for the ensuring the process for collecting Confidential Disclosure Agreements (CDA) and Site Feasibility Questionnaires (FQ) is followed appropriately.  Perform Site Feasibility project team and line management activities, coordinate the efforts of Site Feasibility 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 Site Feasibility 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, Study Start-up, Regulatory Affairs, other interdepartmental team members and sponsors to enable a rapid clinical trial start-up.
• Leads Site Feasibility 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 Site Feasibility Questionnaires (FQ) 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.
• 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 Site Feasibility status for each site in applicable system(s) for the study. 
• 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 Site Feasibility 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 Project Manager in generating changes in scope within the Site Feasibility activities.
• Participates in financial and/or resource forecasting.
• Serves as IQVIA Biotech representative in interactions with the sponsor, as appropriate.
• Oversees team transitioning sites from Site Feasibility to SSU 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 department leadership as requested.
• Performs other duties as required.

KNOWLEDGE, SKILLS & ABILITIES:

• Demonstrated ability in the leadership of a team of individuals in site feasibility and 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.
• 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 oversee Site Feasibility activities in multiple countries, functions, and team members.
• Ability to travel periodically if needed

MINIMUM RECRUITMENT STANDARDS:

• Bachelor’s degree (or equivalent) in science-related field preferred and
• 7 years relevant clinical research experience which includes 2-3 years of experience in a project 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.