Study Start Up Manager (Clinical Trials)

Location: Warsaw, Poland

Annual base pay: zł201,500.00–zł374,100.00, with the final offer depending on qualifications, experience, location, and schedule.

Company

IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Lead global and regional site activation, regulatory, and study maintenance activities.
• Develop study start-up strategies, project plans, and regulatory submission approaches.
• Oversee regulatory submissions, ethics approvals, essential documents, contracts, and site activation deliverables.
• Manage study timelines, budgets, resources, quality metrics, and project information in CTMS and related systems.
• Collaborate with project teams, sponsors, and regional stakeholders to resolve country-specific challenges and mitigate risks.
• Mentor team members and support business development activities, including proposals, bid defenses, and client presentations.

Requirements

• Bachelor’s degree in Life Sciences or a related field.
• At least 7 years of experience in clinical research, study start-up, regulatory affairs, or a related scientific environment, including international experience.
• Strong knowledge of clinical trial regulations, GCP, ICH guidelines, and the drug development process.
• Experience managing complex, multi-country clinical trial start-up activities.
• Leadership, stakeholder management, negotiation, communication, presentation, financial, project management, and organizational skills.
• Proficiency with CTMS and other clinical research systems and technologies.

Culture & Benefits

• Full-time employment.
• Benefits may include health and welfare coverage and other company benefits.
• Additional incentive plans, bonuses, or other compensation may be available depending on the position.