At AstraZeneca, we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that transform lives. We need phenomenal people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

The Global Study Associate Manager is a member of extended global study team supporting delivery of clinical studies within Global Medicines Development (GMD) to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving.

The GSAM works cross-functionally with internal and external partners to deliver delegated aspects of the clinical study in accordance with Global Study Leader (GSL).

Typical Accountabilities:

• In partnership with AZ enablement team, other AZ clinical professionals and external service providers, the GSAM provides oversight to ensure study delivery;
• Leads/contributes to the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc) and related documents (specifications, study specific procedures, descriptions, presentations etc.);
• Maintains and facilitates interactions with internal functions including but not limited to Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other partners to ensure an efficient study delivery to time, costs and quality objectives;
• Contributes to the planning and conduct of internal and external meetings (e.g. Investigators’/Monitors’ meeting);
• Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or providers as appropriate;
• Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues;
• Ensures that all study documents in scope of GSAM’s responsibilities are complete and verified for quality in Trial Master File;
• Supports Global Study Leader with project management and budget management, such as invoice reconciliation;
• Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times;
• For outsourced studies, supports Global Study Leader (GSL) in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study;
• Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Requirements:

• Proven experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years - knowledge of clinical development / drug development process in various phases of development and therapy areas;
• Excellent communication and relationship building skills, including external service provider management skills - excellent stakeholder management and project management skills;
• Excellent knowledge of international guidelines ICH/GCP;
• University degree (or equivalent), preferably in medical or biological sciences or subject area associated with clinical research;
• Proven ability to collaborate as well as work independently;
• Proven leadership skills;
• Computer proficiency, advanced computer skills in day-to-day tasks;
• Excellent verbal and written communication in English.

Next step - Apply today!

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.