Study Start-Up Manager

About the position

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, the SSU Manager may hold different internal titles, such as Senior SSU Manager. The Director, Country Head may assign these titles after confirmation with the Senior Director, Cluster Head / Executive Director, Regional Head.

Responsibilities

• 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.
• Review informed consents at the site level, coordinate additional reviews with internal stakeholders, and facilitate the return of comments/approvals to sites for action.
• Submit proper application/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 per required timelines during the start-up period.
• Follow up on outstanding actions with study sites during the start-up period 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 performed by LSAD or delegate to ensure that all country and site-level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness.
• Provide regular information to Line Managers at the country level on study and planned study milestones/key issues during the start-up period.
• Provide feedback on any research-related information including sites/investigators/competing studies that might be useful for the local market.
• Support SMM in different initiatives (local, regional, or global) as agreed with the SMM Line Management.

Requirements

• Bachelor's degree in a related discipline, preferably in life science, or equivalent qualification.
• Minimum 4+ years' experience with oncology startup.
• Minimum 4+ years' experience with informed consent review.
• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations, basic knowledge of GMP/GDP.
• Integrity and high ethical standards.
• Good analytical and problem-solving skills.
• Team-oriented and flexible; ability to respond quickly to shifting demands and opportunities.
• 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 adapt to work with IT systems.

Nice-to-haves

• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
• 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.
• Good analytical and problem-solving skills.
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
• Good cultural awareness.

Benefits

• 401(k) plan
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage