Senior Local Study Associate Director

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

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.

This Job description applies to both senior and non-senior role levels with additional responsibilities and expectations applicable for the senior role, defined in document ‘Site Management and Monitoring (SM&M) Biopharmaceuticals Senior Role Definition’ (GUID-0028372).

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.
• Conduct required co-monitoring visits, accompanied site visits, and training visits with study CRAs to ensure quality and consistency.
• Proactively identify risks, facilitate the swift resolution of complex study problems, and escalate as necessary.
• Organize and lead regular, agenda-driven Local Study Team meetings, fostering transparent communication and teamwork.
• Build and maintain positive relationships with Local Study Team members, site staff and global stakeholders to ensure smooth study delivery.
• Report study progress and updates to the Global Study Associate Director, Global Study Team, and SMM/Study Operations Lead, as applicable.
• Contribute to patient recruitment strategies and maintain regular contact with investigators to support enrolment goals.  
• Develop, maintain, and review a study-level country risk management plan, managing sites, stakeholders, vendors, and customers to ensure timely risk identification and mitigation.
• Coordinates closely with National Coordinating Investigator or National Lead Investigator on recruitment and other study matters, when applicable.
• Plans and leads National Investigator Meetings in alignment with local codes, as needed.
• Assists with forecasting for study timelines, resource needs, recruitment, budgeting, materials, and investigational product supply.
• Ensures set-up, updating, and access to business-critical systems for activities such as Safety Reporting, Regulatory Submissions, and Clinical Trial Transparency at the country level.
• Ensure accuracy and compliance of all study payments, adhering to local regulations and agreements.  
• Participate in the training and coaching of new Local Study Team members, ensuring quality and adherence to ICH-GCP standards and AstraZeneca procedures.
• Maintain the study eTMF in an “Inspection Ready” state, ensuring documentation is complete and current.
• Plan and lead audit and regulatory inspection activities, working with the Clinical Quality Associate Director (CQAD) and Quality Assurance teams.
• Contribute insights for process development and ongoing improvement within the organization.
• Keep line managers regularly informed about study status, milestones, key issues, and team performance.
• Ensure full compliance with local policies, codes of ethics, and business practices in all study-related activities.
• Provide feedback on research trends, competing studies, or site/investigator information that can benefit the local market.
• Collaborate with the local Medical Affairs team as needed, for optimal study delivery and scientific quality.
• Actively support SMM initiatives at the local, regional, or global level as agreed with line management.

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).

Job Location: Mumbai

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.

Key stakeholders and relationships

Multiple functions & departments across R&D Research organisations and staff

External professional and regulatory organizations

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

You can find alternative messaging to use in the ‘Global Talent Attraction Story messaging’ section of the Global Playbook on the Employer Brand Portal - try to use other examples in order to make it different for candidates!

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

If you have site, country or departmental social media then feel free to switch any of the above links.

Date Posted

08-Apr-2026

Closing Date

12-Apr-2026

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.

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 authorisation and employment eligibility verification requirements.