IQVIA is seeking a highly skilled Trial Delivery Manager/Senior Clinical Lead to oversee and coordinate clinical trial management activities for both internally managed and outsourced trials. This role involves ensuring compliance with SOPs, Good Clinical Practice (GCP), and local regulatory requirements. The identified candidate will lead the Study Management Team, manage trial documentation, and ensure inspection-readiness while acting as the primary contact for regional and country staff.

Key Responsibilities:

• Adhere to SOPs, policies, GCP, and local regulatory requirements.
• Comply with relevant training requirements.
• Lead the Study Management Team and provide updates on deliverable status.
• Ensure availability of required reports for real-time tracking of trial status.
• Manage timely and accurate documentation and communication of trial progress.
• Maintain inspection-readiness of the Study Management Team (SMT).
• Act as the primary contact for Country and Regional staff and local teams.
• Partner with global counterparts to oversee central activities from planning to trial close-out.
• Ensure issue escalation and drive resolution.
• Work closely with the Trial Team to resolve CAPAs timely.
• Contribute to data collection for site selection and participate in feasibility assessments.
• Establish enrollment commitments and ensure actual enrollment meets projections.
• Ensure robust recruitment/contingency plans are in place for each region.
• Perform Annual Quality Review of files and ensure archiving and retention of documents.
• Establish country budgets and monitor actuals vs. forecast for Out-of-Pocket Expenses.
• Oversee selected vendors and review/approve vendor invoices.
• Monitor budgets and expenditures per planned trial budget.
• Create and update trial-specific documents, including Monitoring Guidelines, Informed Consent Forms, and IMP-related documentation.
• Provide input into cross-functional documents such as safety-related documents and protocol deviations.
• Ensure creation of trial-specific training materials and deliver training as needed.
• Coordinate Investigator Meetings and maintain excellent working relationships with internal stakeholders.
• Ensure compliance with Health Authority regulations and guidelines.
• Participate in Health Authority inspections and internal audits.
• Coordinate data cleaning towards a timely database lock.
• Act as central expert for assigned protocols.
• Contribute to process improvement and training initiatives.
• Lead and/or participate in special initiatives and task forces.
• Execute clinical trial management services autonomously.
• Provide coaching/mentoring to less experienced staff.
• Assume additional responsibilities or special initiatives such as Champion or Therapeutic Area Expert.
• Lead teams across projects/programs on insourced and outsourced studies.

Education and Experience Requirements:

• BS degree or equivalent in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• 6 or more years of clinical trial management experience in the pharmaceutical industry or large CRO.
• Strong working knowledge of ICH-GCP, local laws, and regulations.
• Proven track record in managing various aspects of trials from start-up to database lock and trial closure.
• Effective leadership and delegation skills.
• Experience in coordinating global or regional teams in a virtual environment.
• Strong project planning/management and independent complex decision-making skills.
• Solution-oriented with proactive risk identification and mitigation.
• Strong IT skills, including knowledge of standard Microsoft applications and willingness to learn new systems.
• Monitoring experience or relevant experience in data management or central monitoring.
• Proficient in speaking and writing local country language and English.
• Strong analytical skills and ability to manage ambiguity.
• Experience in developing presentations and presenting key information to stakeholders.
• Ability to understand and oversee country and vendor budgeting processes.

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

The potential base pay range for this role, when annualized, is $112,000.00 - $228,800.00. 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.