Study Start-Up Manager
Job Title: Study Start-Up Manager
Introduction to role
The Study Start-Up Manager (SSU Manager) is responsible at the country level for managing and conducting start-up activities in compliance with AstraZeneca procedures, documents, local and international guidelines such as ICH-GCP, and relevant regulations. The SSU Manager will prepare, review, track, and manage site regulatory documentation at both country and site levels, maintaining, reviewing, and reporting on site performance metrics. Working closely with CRAs and the Local Study Team/Local Study Associate Director, the SSU Manager ensures that study start-up activities and milestones are achieved efficiently and on time. Depending on experience and performance, the SSU Manager may hold different internal titles such as Senior SSU Manager.
Accountabilities
• Contribute to ensuring that clinical and operational feasibility assessments of potential studies are performed to the highest quality.
• Accountable for study start-up and regulatory maintenance, including the collection, preparation, review, and tracking of documents for the application process.
• Responsible for submitting proper applications/documents to Regulatory Authorities and/or IEC/IRB during the start-up period.
• Actively participate in Local Study Team (LST) meetings.
• Update CTMS and other systems with data from study sites as required during the start-up period.
• Follow up on outstanding actions with study sites to ensure timely resolution.
• Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs, and local requirements. Support QC checks to ensure all trial essential documents are collected and verified before study start.
• Provide regular updates to Line Managers at the country level on study milestones/key issues during the start-up period.
• Provide feedback on research-related information including sites/investigators/competing studies useful for the local market.
• Support SMM in various initiatives (local, regional, or global) as agreed with SMM Line Management.
Upon local decision, additional responsibilities may include:
• Prepare, review, and negotiate contracts with investigational sites.
• Support site selection by identifying and assessing potential sites/investigators.
• Continue submitting proper applications/documents to IEC/IRB and Regulatory Authorities throughout the study duration.
• Assist in initial forecasting for budget, study materials, and drug supplies. Plan applicable local drug activities.
Essential Skills/Experience
• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations, basic knowledge of GMP/GDP
• Basic understanding of drug development process
• Good collaboration and interpersonal skills.
• Good verbal and written communication skills.
• Excellent attention to details.
• Excellent understanding of Clinical Study Management and study start-up
• Good negotiation skills.
• Good ability to learn and to adapt to work with IT systems.
Desirable Skills/Experience
• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
• Integrity and high ethical standards.
• Good analytical and problem-solving skills.
• Good financial management skills.
• Basic change management skills.
• Good intercultural awareness.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
At AstraZeneca, we are proud to lead the way in international markets as the fastest-growing pharmaceutical company. We are bold in setting a new direction where patients live longer and enjoy better quality of life. By combining new medicines with unique healthcare solutions across the entire patient journey, we bring transformative drugs to those who need them most. Our team is united by a strong sense of belonging, offering a wide scope of opportunities to learn from the best global talent. Here, you can embrace challenges in an open community that fosters learning and development. With strong leadership backing, you will join a culture of collaboration where colleagues work together to solve problems without fear of failure.
Ready to make a difference? Apply now to join our dynamic team!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
