Senior Trial Delivery Manager - Sponsor Dedicated

About the role

iQvia is looking for a Global Senior Trial Delivery Manager (sponsor dedicated) in Warsaw. The role leads the Study Management Team and coordinates clinical trial management activities for internally managed and/or outsourced trials, from site feasibility and set-up through execution and closure. It works closely with the Global Clinical Development Operations Trial Leader and covers both insourced and outsourced studies.

Key responsibilities

• Lead the Study Management Team, keep it inspection-ready and report deliverable status to all trial team members.
• Partner with the Global Trial Lead on central activities from planning and start-up through close-out, and escalate and resolve issues.
• Manage country and regional budgets, vendor oversight and approval of vendor invoices and spend.
• Contribute to site selection, feasibility, enrollment commitments and recruitment contingency plans.
• Ensure CAPAs are resolved, coordinate data cleaning toward database lock, and prepare for Health Authority inspections and audits.
• Create and maintain trial documents such as Monitoring Guidelines, Informed Consent Forms, Blinding Plans and IMP documentation, and provide training to regional, site and CRO staff.
• Act as central expert for assigned protocols and coordinate investigator meetings.

Required profile

• BS degree or equivalent in Life Sciences (Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• 6-8 years of clinical trial management experience in the pharma industry or CRO, with specific therapeutic area experience.
• Proven track record managing trials from start-up to database lock and closure, and leadership of a team and global/regional teams virtually for at least 2, preferably 3 years.
• Strong knowledge of ICH-GCP, local laws and regulations, and of the therapeutic area.
• Proficiency in the local country language and English, with strong communication and decision-making skills.

Required skills

• Knowledge of Microsoft applications, Trial Master File and Clinical Trial Management Systems, and willingness to learn new systems.
• Monitoring experience is recommended, or data management or central monitoring experience.
• Ability to plan budgets, oversee vendor spend and present to stakeholders.

The potential base pay range, when annualized, is 217,800 to 404,600 PLN, depending on qualifications, location and schedule; incentives, bonuses and benefits may also apply. The role is Poland exclusive.