IQVIA Cell and Gene Therapy Logistics Manager, Oncology, Remote - IQVIA Biotech in Boston, Massachusetts
Cell and Gene Therapy Logistics Manager
Exciting opportunity @IQVIA Biotech as a Cell and Gene Therapy Logistics Manager.
Candidates must have 5+ years of Cell and Gene Therapy experience as a CRA or CTM. Previous CAGT experience as a study coordinator, CRA or CTM required. This position will collaborate closely with sites, sponsor, and manufacturing to align the timing of product delivery with subject visit dates. Strong communication, organization, and collaboration skills a must.
Responsible for the planning, tracking, and reporting of patient samples and blood/cellular products inherent to cellular therapy (CAR-T), and other logistically complex trials. Assists in training, site management, and aspects of cohort management directly-related to cell therapy-based trials.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Responsible for all activities related to implementation and execution of clinical studies that include:
Work with Clinical Trial Manager (CTM) to ensure the client is regularly and clearly updated on the status of patient slot allocation, donor scheduling (if Allogeneic), apheresis scheduling, manufacturing timelines, shipment status and other elements of cellular therapy logistics. Communicate and document all interactions with client as required by SOP and Communications Management Plan.
Develop and implement the study-specific Logistics Management Plan.
Participate in bid defense preparations. Lead the Clinical delivery strategy at bid defense presentations in partnership with the Clinical Trial Manager (CTM) or representative. Understand the overall project strategy and translate the agreed upon clinical approach to a successful practical delivery model.
Attend scheduled and ad hoc client meetings as necessary.
Responsible for assuring needs of clinical sites are met by being a point of contact for various logistical considerations, including:
Coordinating patient and donor (if Allogeneic) scheduling timelines for apheresis, cell manufacturing, lymphodepletion, and infusion.
Support the CTM in informing sites about cohort slot availability, screening status, and pre-screening scheduling considerations.
Contact appropriate site staff proactively to coordinate and confirm shipment timelines for apheresis yield.
Serve as liaison between study sites and logistics vendors, couriers, and the sponsor.
Develop site sample-tracking tools and training materials.
Complete training for, and utilize/implement, logistics-vendor tracking platforms/interfaces such as TrakCel, Vinetti, Cryoport, etc. (when applicable).
Participate in Site Initiation Visits (SIVs) and/or SIV “Dry-Run” with CRA and applicable site staff, when necessary.
Manage quality and regulatory compliance among investigational sites.
Manage project milestones and proactively address deficiencies:
- Attend and provide information at weekly client teleconferences/team meetings.
Assure that the appropriate IQVIA Biotech and/or sponsor SOPs are followed.
Ensure all project documentation is appropriately filed per IQVIA Biotech SOPs.
- Participate in and/or serve as a champion for department and company-wide initiatives.
KNOWLEDGE, SKILLS & ABILITIES:
Thorough knowledge of clinical research process, including medical and therapeutic areas, phases and medical terminology.
Prior experience as a Clinical Research Associate or equivalent site-facing/site-based experience.
Excellent communication skills (verbal and written) with ability to express complex ideas.
Strong understanding of cohort-based studies and slot allocation methods preferred.
Strong presentation skills.
Strong negotiation skills with the ability to communicate difficult concepts clearly.
Excellent organizational skills and proficient at multi-tasking with strong attention to detail.
Ability to work independently, prioritize and work with a matrix team environment is essential.
Strong interpersonal skills, with flexibility to adapt to changing situations.
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
Prior experience leading, liaising and coordinating cross-functional project teams preferred.
Ability to lead, motivate and coordinate local and virtual teams.
Ability to manage multiple priorities within various clinical trials.
Ability to reason independently and recommend specific solutions in clinical settings.
Ability to delegate, effectively prioritizing own and workload of project team members.
Understanding of basic data processing functions; ability to effectively use automated systems and computerized applications.
Possesses cross cultural awareness and is able to adapt appropriately.
Working knowledge of current ICH GCP guidelines and applicable regulations.
Ablility to mentor CRAs, when needed.
Working knowledge of Microsoft Word, and strong command of Excel.
Willingness and ability to travel domestically and internationally, as required.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
Ability to travel domestically and internationally
Very limited physical effort required to perform normal job duties
MINIMUM RECRUITMENT STANDARDS:
BS/BA (or equivalent) in one of the life sciences plus 7 years direct experience with clinical studies
Within total experience, 5 years working as a Clinical Monitor/CRA or related role with data handling or analysis
Experience with cellular therapy and CAR-T trials preferred
Equivalent combination of education, training and experience
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 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 .
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
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 email@example.com to arrange for such an accommodation.
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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