Global Study Manager
Duration - 12 months (interim)
Location - Remote
Inside IR35
The Global Study Manager is responsible for supporting the delivery of clinical studies ensuring quality and compliance. The exact accountabilities will differ depending on the exact nature of the clinical program, so a high degree of flexibility is required.
Responsibilities:
• Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.
• Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.
• Manage the set-up of third-party vendors assessing initial statement of work and budget, as well as the change order process.
• Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data.
• Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.
• Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate.
• Oversight of third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report.
• Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies.
• Assist in the clinical trial insurance process; track approvals, revisions and renewals of certificates.
• Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget.
• Support risk management and quality efforts to ensure study compliance.
• Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.
• Prepare presentation material for meetings, newsletters and websites.
• Support the study team in the implementation of audits and regulatory inspections.
• Contribute to review of new/amended/unique SOPs and guidance documents.
Essential Skills/Requirements:
University degree / Bachelor’s degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience
• Minimum of 3-4 years of progressive clinical trial experience
• Experience of working with and delivering through strategic partners and 3rd party vendors
• Excellent knowledge of ICH-GCP principles
• Demonstrated verbal and written communication skills
• Early Phase experience (phase I and IIa)
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
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