Specialist I / Specialist II, Evidence Project Management

The Medical Evidence Delivery Team within Oncology Business Unit (OBU) is responsible for strategic planning and operational delivery of interventional and observational AstraZeneca sponsored studies (AZ studies), externally sponsored scientific research (ESR) and early access programs (EAP) in order to generate the evidence to build confidence in and provide access to AstraZeneca therapies for patients in need.

Specialist I (CL C), Evidence Project Management (Spec I EPM) will support the Associate Director, Evidence Project Management I/II (AD I/II EPM) and Manager I/II, Evidence Project Management (Mgr I/II EPM) in the operational delivery and oversight of company sponsored evidence studies and/or externally sponsored research and/or early access programs (EAP) to time, cost and quality. The Spec EPM works cross-functionally with internal and external partners to deliver certain aspects of the clinical study as delegated by the AD EPM/Mgr EPM (for internally sponsored studies and EAPs) and by ESR Global Operations Lead (for ESR) and in accordance with current clinical trial regulations (e.g. ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies, when relevant – with the clinical outsourcing model (EMPOWER), and best practices and in line with AZ values and behaviours.

Within ESR Specialist I will support Global ESR Ops Lead and broader internal team by coordinating administrative tasks, managing operational and financial aspects (e.g. invoice reconciliation, Purchase order management), and ensuring compliance with company policies and regulations. ESR Specialist will interact with external sponsors and internal teams, overseeing study management systems, facilitating drug-related processes, and supporting document and system management. Additionally, ESR Specialist I will provide subject matter expertise for process improvements, training activities, and system development, ultimately contributing to the efficient execution and reporting of ESR studies.

Specialists II, Evidence Project Management are the group of most experienced Spec EPMs. Specialist II accountabilities extend to include mentorship and leadership responsibilities within the team. They play a crucial role in training and mentoring new team members, acting as buddies to facilitate smooth onboarding. They share more responsibilities with more senior roles (Manager EPM, Global ESR Ops Lead) Specialists II serve as process experts for assigned tasks and coordinate team efforts on complex activities. Specialist II are also expected to represent the Specialists Team in continuous improvement and system enhancement initiatives, contributing their expertise to drive efficiency and innovation. As part of their professional development, they take on higher-level tasks, demonstrating their ability to handle increased responsibility and complexity within assigned studies and projects
Based on business requirements and project complexity, specialists I/II will be allocated a diverse portfolio comprising AstraZeneca-sponsored studies, Early Access Programs, and Externally Sponsored Research initiatives across different therapeutic areas.

For company Sponsored Studies
• Executes activities enabling AZ to fulfil sponsor oversight responsibilities and to maintain inspection-readiness, including
• Maintain Study Inspection Readiness Tools
- Coordinate and oversee periodic study-level TMF/Master File (MF) QC
- Perform Periodic TMF/MF QC on behalf of Study/EAP Management
- Customization of the study’s Expected Document List (EDL) in collaboration with the CROs
- Collaborate with extended study team to develop, maintain, and execute activities according to the study Sponsor Oversight Plan
- Ensure appropriate documentation of oversight and inspection-readiness tasks is maintained
- Ensure handover documents are created, signed and filed in TMF
- In collaboration with CRO, support creation, execution and maintenance of AZ TMF/MF Plan
• Supports key study start-up activities, in collaboration with CRO and internal functions as needed
- Internal system’s set up (VCV, SPOL, Shared mailbox, etc.)
- D-code requests
- Creation and maintenance of Study Team Charter / R&R document
- Creation and maintenance of study team contact list
- Creation and maintenance of Decision and Issue trackers Coordination & documentation of internal study team meetings
- Provide input into development of study/EAP plans and study/program documents as needed
• Support compliance and quality deliverables
- Assist recording of QIs in VQV
- Assist in audit/inspection preparation as needed
- Monthly review of the data present in PharmaCM
- Monthly review of workbooks
• Create and maintain internal study/program trackers and systems as needed, including mailboxes and collaboration forums
- Ensure new team members have access to all required systems
• Enter/maintain accurate data relating to study/EAP scope and progress on all business systems throughout the course of study every month
• Support budget management activities including
- Raise POs
- Maintain Support invoice reconciliation
• EAP program participation, status and tracking:
• creation of country tracker aligned with agreed country participation timelines/exit strategy
• creation and maintenance of study team contact list
• creation and maintenance of Decision and Issue trackers
• Provide program level tracking and updates
• Validate source information for stakeholder reporting
• Maintain SSI with approved protocol
• US specific local operational requirements
• Ensure EAP MF Archiving
• Active participation in CRO operational governance meetings

For ESRs:
• Coordinate administrative tasks throughout the study lifecycle, including start-up, execution, close-out, and reporting of Externally Sponsored Research (ESR).
• Manage operational and financial aspects of ESRs, including system maegement, document coordination, and sponsor interactions, PO creation, invoice reconciliation .
• Support study teams with various tasks such as IRB approvals, drug orders, transparency reporting, and system inquiries.
• Ensure compliance with company policies, SOPs, and regulations throughout all study-related activities.
• Provide expertise in process improvement, training, and system development as needed.

Requirements

Essential

▪ Bachelor’s degree required preferably in medical or biological science or equivalent by experience
▪ Knowledge and understanding of the clinical study and drug development processes, GCP/ICH guidelines
▪ Excellent written and verbal communication skills as well as proven collaboration and influencing skills
▪ Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
▪ Demonstrated ability to collaborate as well as work independently
▪ Ability to effectively work with Clinical Research Organisations/External Providers
▪ Proven ability to interact widely and effectively within the company across regions, functions and cultures
▪ Ability to manage competing priorities

Desirable

▪ Advanced degree in medical or biological sciences or field associated with clinical research
▪ Proven organizational and analytical skills
▪ Previous administrative training/experience

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.