Study Start-Up Manager

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

Accountabilities for this role include:

• Accountable for study start-up and the maintenance of regulatory and ethics committee (EC) submissions, overseeing the collection, preparation, review, and tracking of documents required for the application process.
• Where applicable, responsible for submitting the appropriate applications and documentation to Regulatory Authorities and/or IEC/IRB during the start-up period, liaising with regulatory bodies and ethics committees and ensuring expertise in the regulatory field.
• Actively participate in Local Study Team (LST) meetings. In some countries, these activities may be performed by the regulatory department.
• Ensure timely updating of Clinical Trial Management System (CTMS) and other relevant systems with study site data during the start-up or application period, as required.
• Follow-up on outstanding actions related to submission with study sites during start-up, ensuring timely resolution.
• Ensure the timely collection and upload of essential documents into the eTMF in accordance with ICH-GCP, AstraZeneca SOPs, and local requirements relating to submissions. Supports quality control checks performed by LSAD or delegate to verify that all country and site level trial essential documents required by ICH-GCP are collected and correct prior to site readiness for enrolment, in accordance with AstraZeneca SOPs.

Provide regular updates to LSAD or Line Managers at the country level regarding study progress, planned milestones, and key issues throughout the start-up period.

• Support Site Management & Monitoring (SMM) in various initiatives at local, regional, or global levels, as agreed with SMM Line Management. Additional responsibilities may be assigned depending on local decisions.

• Remain accountable for the ongoing, proper submission of application documents to IEC/IRB and Regulatory Authorities throughout the start-up period and study duration. • Other responsibilities applicable within country may be covered by an addendum to this job description.

Education and experience:

Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification aligned to the knowledge and skills of the role and ensures successful conduct of responsibilities and appropriate interactions with internal and or external stakeholders.

Relevant knowledge and ability to fulfil key responsibilities, including but not limited to:

Drug development process, International guidelines ICH-GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, Clinical Study Management including site selection/set-up.

Role-Required Skills:

• Personal Effectiveness & Drives Self-Accountability
• Learning Agility
• Financial, Technology & Process Competency
• Active Listening, Fluency in written & spoken business-level English
• Act with Integrity & high ethical standards
• Effectively work as part of a team, in person and virtual settings, demonstrates cultural awareness
• Identify and champion more efficient delivery of quality clinical trials with optimised cost and time.

Ability to travel nationally/internationally as required

• Valid driving license, if country employment requirement
• Communication & Teamwork – Influencing, Collaboration, Impactful Site conversations
• Effective, risk-based thinking – Plans & Aligns, Strategic thinking, Problem Solving, Critical Thinking, Decision Making, Effective Issue Management
• IMP Development & Regulation - Study vendor & Bio sample oversight
• Clinical Study Operations (GCP) & Quality Management - Study site selection & set-up
• Deliver Priorities Results & Impact - Project Management, Drives results.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

You can find alternative messaging to use in the ‘Global Talent Attraction Story messaging’ section of the Global Playbook on the Employer Brand Portal - try to use other examples in order to make it different for candidates!

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

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