IWRS/IVRS

Central Laboratory ePRO/eCOA Imaging Translation and printing Ancillary supplies and investigator meetings Review and approve vendor deliverables, invoices, and spend. Ensure vendor performance aligns with trial plans, budgets, and quality expectations. Quality, Compliance & Inspection Readiness Ensure continuous inspection readiness in accordance with ICH-GCP, applicable regulations, and sponsor SOPs. Lead or contribute to CAPA development and resolution. Support Health Authority inspections, internal audits, and quality reviews. Partner with Quality & Compliance stakeholders to ensure effective oversight. Enrollment, Feasibility & Risk Management Lead feasibility activities and provide data-driven recommendations. Establish and track regional enrollment commitments, ensuring alignment with projections. Ensure robust recruitment and contingency plans are in place. Proactively identify risks, escalate issues, and drive resolution. Documentation, Systems & Trial Deliverables Oversee trial documentation, filing, archiving, and retention. Create, review, and maintain trial-specific documents, including: Monitoring Guidelines Informed Consent Forms IMP and blinding documentation Feasibility and site selection materials Support

HA/EC/IRB

submissions with required central documents. Coordinate data cleaning activities to support timely database lock. Leadership, Mentorship & Continuous Improvement Lead teams across projects or programs. Provide coaching and mentoring to less experienced team members. Lead or participate in special initiatives, task forces, and process improvement efforts. Contribute innovative ideas to enhance operational efficiency and quality across the FSP partnership. Level Differentiation (Base Level) Independently manages complex trials with limited oversight. Demonstrates strong operational leadership and stakeholder management. Owns central trial oversight activities and delivers consistent, high-quality results. (Advanced Level) Leads program-level or high-impact trials with increased complexity. Manages and mentors multiple team members across insourced and outsourced studies. Serves as a Therapeutic Area Expert or Functional Champion, influencing strategy and best practices. Proactively identifies and resolves budget, resourcing, and operational risks. Qualifications & Experience Education Bachelor's degree (or equivalent) in Life Sciences (e.g., Biology, Chemistry, Nursing, Pharmacy).

Experience Base:

6+ years of clinical trial management experience in pharma and/or CRO environments.

Advanced:

8+ years of clinical trial management experience, including leadership of complex global studies. Proven experience managing trials from start-up through database lock and close-out. Experience coordinating global, virtual teams in a large matrix environment for 2-3+ years. Therapeutic area experience required. Technical & Professional Skills Deep knowledge of ICH-GCP, regulatory requirements, and clinical operations best practices. Strong project management, planning, and risk mitigation skills. Demonstrated ability to manage country and vendor budgets, including OOPs and cost drivers. Experience with

CTMS, TMF

systems, and Microsoft applications. Monitoring experience preferred (or equivalent central monitoring/data management experience). Strong analytical, decision-making, and communication skills. Fluent in English; local language proficiency as required. Willingness to travel as needed. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Learn more at https:

//jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. 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.

https:

//jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $93,100.00 - $285,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled Apply Now\nActive Filters\nTrial Delivery Manager...\nWayne, PA\nClear All\nPowered By Cookie Policy We use cookies to improve your experience on our site. 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