Local Study Associate Director (Biopharmaceutical)

Short Role Description

• The Local Study Associate Director (LSAD) is responsible for managing their assigned clinical studies and leading Local Study Teams (LSTs) to ensure delivery of country-level study commitments according to agreed budgets, timelines and resources assigned by Director Country Head (DCH) or Director Site Management & Monitoring (DSMM).
• All activities must comply with AstraZeneca Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. This role reports to DCH or DSMM, depending on country-specific organisational set-up and works in alignment with Global Study Team (GST), for delivery of assigned studies. Beyond leadership of LSTs, the LSAD may also engage in site monitoring activities as required, supporting the flexible capacity model. The LSAD ensures that study sites are appropriately identified, qualify for participation, are set-up, initiated, and monitored throughout the study, and that closure and archiving of site documentation are completed according to standards.

​Typical Accountabilities

Accountabilities for this role include:

• Hold overall responsibility for fulfilling country-level study commitments and ensuring timely, highquality data delivery.
• Lead the Local Study Team(s)—comprising Clinical Research Associate’s (CRAs), Clinical Study Administrator’s (CSAs), and other contributors—for assigned studies, fostering collaboration and high performance.
• Drive optimal performance and compliance of Local Study Team(s) with AstraZeneca Procedural Documents, ICH-GCP requirements, and local regulations.
• Ensure the highest quality in the clinical and operational feasibility assessment of potential studies, as required.
• Coordinate and oversee the site selection process, identifying potential sites and investigators, conducting initial site quality risk assessments, and, when necessary, performing Site Qualification Visits to evaluate suitability and quality risk
• Ensure timely submission of required applications and documentation to Ethics Committees/IRBs and, in partnership with Regulatory Affairs, supports the delivery of study submissions to Regulatory Authorities, in line with local regulations.
• Prepare accurate country-level financial agreements and maintain up-to-date study budgets within the clinical financial system, ensuring regular checks and alignment with input from the Director, SMM or Director, Country Head and Clinical Finance reporting function, as appropriate.
• Ensure the set-up and ongoing management of studies within CTMS, electronic Trial Master File (eTMF), study finance systems, and any other tools or local platforms necessary to meet countryspecific laws and requirements.
• Oversee, manage, and coordinate all monitoring activities from site activation to closure, in accordance with Monitoring Plans, and thoroughly review monitoring visit reports, offering support and guidance to monitors.

Education, Qualifications, Skills and Experience

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.
• Previous experience in the pharmaceutical industry, preferably in Clinical Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies)

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

• Drug development process and related GxP processes, International guidelines ICH-GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, Clinical Study Management including project management, monitoring, study drug handling and data management.

Role-Required Skills:

• Personal Effectiveness & Drives Accountability in Others
• Learning Agility
• Financial, Technology & Process Competency
• Active Listening, Fluency in written & spoken business-level English
• Act with Integrity & high ethical standards
• Effectively lead a team across in-person and virtual settings to deliver shared goals, 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
• Clinical Study Operations (GCP) & Quality Management - RbQM: Interpreting and implementing the Monitoring Plan, Study site selection & set-up
• Deliver Priorities Results & Impact - Project Management, Recruitment/Retention Planning & Action.

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.