Study Start Up Manager, Poland, IQVIA Biotech
Job Location:
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Job Overview
IQVIA Biotech is seeking an experienced Study Start-Up Manager to lead and oversee all site activation regulatory and maintenance activities for assigned clinical studies and programs. This role is accountable for delivering study start-up strategies managing timelines resources budgets and regulatory requirements while ensuring high-quality execution and compliance across global clinical trials.
Key Responsibilities
Lead global and regional site activation and regulatory activities from study start-up through maintenance phases.
Develop and execute study start-up strategies project plans and regulatory submission approaches to achieve study timelines.
Oversee regulatory submissions ethics approvals essential documents contracts and site activation deliverables.
Provide strategic guidance on regulatory requirements country-specific challenges and risk mitigation solutions.
Collaborate cross-functionally with project teams sponsors and regional stakeholders to drive successful study delivery.
Monitor study progress quality metrics timelines budgets and resource utilization.
Maintain accurate project information within CTMS and other tracking systems.
Mentor and coach team members promoting operational excellence and knowledge sharing.
Support business development activities including bid defenses proposals and client presentations.
Qualifications & Experience
Bachelors degree in Life Sciences or a related field.
Minimum 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.
Proven experience managing complex multi-country clinical trial start-up activities.
Excellent leadership stakeholder management negotiation communication and presentation skills.
Strong financial project management and organizational capabilities.
Demonstrated ability to manage multiple priorities and deliver results through cross-functional teams.
Proficiency with CTMS and other clinical research systems and technologies.
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
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 zł201500.00 - zł374100.00. 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.Required Experience:
Manager
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
