Clinical Study Administrator Contracts and Budgets

Typical Accountabilities

Study coordination and administration

• Assist the Local Study Team with the coordination and administration of clinical studies from startup through execution and closeout.
• Act as the main local administrative contact and work closely with CRAs and/or LSAD for the duration of assigned studies.
• Coordinate administrative tasks during the study process audits and regulatory inspections in line with company policies and SOPs.

Document management and submissions

• Support the collection preparation review and tracking of documents required for the application process.
• Support the Study Startup team with timely submissions to Ethics Committees/Institutional Review Boards (EC/IRB) and where applicable Regulatory Authorities.
• Take operational responsibility for correct setup and ongoing maintenance of the local electronic Trial Master File (eTMF) and Investigator Study File (ISF) ensuring document tracking in accordance with ICHGCP and local requirements to maintain inspection readiness.
• Ensure all study documents are prepared for final archiving and support CRAs with ISF closeout activities.
• Contribute to the production and maintenance of study documents ensuring compliance with required templates and versions.
• Manage clinicalregulatory documents in the Global Regulatory management system as required.
• Manage clinicalregulatory documents for electronic applications and submissions complying with Submission Ready Standards (SRS) to support efficient publishing and delivery to regulatory authorities where applicable.
• Contracts payments and legal interactions
• Serve as primary point of contact for legal negotiations related to confidentiality agreements and amendments.
• Process studylevel and sitelevel amendments.
• Prepare and/or support sitelevel contract preparation except where a specific local role is assigned.
• Prepare support and perform payments to Health Care Organisations (HCO) and Health Care Professionals (HCP) in accordance with local regulations.
• Systems tracking and materials
• Set up populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. Clinical Trial Management System CTMS) and support others in the use of these systems except in countries with a designated system administrator.
• Manage and contribute to the coordination and tracking of study materials and equipment.
• Interface with Data Management Centres and/or Global Clinical Solution representatives to support delivery of studyrelated documents and materials.
• Stakeholder engagement and communication
• Interface with investigators external service providers and Clinical Research Associates (CRAs) to facilitate effective document collection and study delivery.
• Lead practical arrangements for internal and external meetings (e.g. study team meetings monitors meetings investigators meetings) liaising with internal and external participants and vendors in line with applicable international and local codes.
• Prepare contribute to and distribute material for meetings newsletters and web content in alignment with LST and global stakeholders.
• Perform document layout and language checks as well as copying and distribution. Provide support for local translation and English language checks as required.
• Handle printing and distribution of documents (e.g. letters meeting minutes) and manage and archive study and countryrelated emails.

Compliance

• Ensure compliance with AstraZenecas Code of Ethics policies and procedures including those related to people finance technology security and Safety Health and Environment (SHE).
• Adhere to all relevant local national and regional legislation.
• Carry out additional countryspecific tasks in accordance with local organisational needs when assigned.

Education Qualifications Skills and Experience

Education and experience

• Bachelors degree aligned to the knowledge and skills required for the role.
• 0 experiencerequired
• Relevant knowledge of the drug development process international guidelines (ICHGCP) and applicable country regulations.

Rolerequired skills

• Personal effectiveness and strong selfaccountability.
• Learning agility.
• Financial technology and process competency.
• Active listening and fluency in written and spoken businesslevel English.
• High integrity and ethical standards.
• Ability to work effectively as part of a team in both inperson and virtual settings; demonstrates cultural awareness.
• Ability to identify and champion more efficient delivery of quality clinical trials with optimised cost and time.
• Ability to travel nationally and internationally as required.
• Valid driving licence if required by country of employment.
• Strong communication and teamwork skills including collaboration business partnering and impactful site conversations.
• Effective riskbased thinking including planning and alignment problem solving critical thinking and decision making.
• Clinical study operations (GCP) and quality management including Good Documentation Practice (GDP).
  

Date Posted

Closing Date

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