Senior Specialist Study Management at AstraZeneca

Bengaluru, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

03 Feb, 26

Salary

0.0

Posted On

05 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Study Management, Regulatory Compliance, Risk Based Quality Management, Training, Monitoring, Data Management, Adverse Event Reporting, Site Qualification, Document Management, Quality Assurance, Collaboration, Problem Solving, Communication, Inspection Readiness, Project Management, Performance Tracking

Industry

Pharmaceutical Manufacturing

Description

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. Typical Accountabilities • Contributes to the selection of potential investigators. • In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. • Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. • Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. • Actively participates in Local Study Team (LST) meetings. • Contributes to National Investigators meetings, as applicable. • Initiates, monitors and closes study sites in compliance with AZ Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. • Updates CTMS and other systems with data from study sites as per required timelines. • Manages study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. • Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits. • Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. • Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. • Ensures data query resolution in a timely manner. • Works with data management to ensure robust quality of the collected study data. • Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. • Prepares and finalises monitoring visit reports in CTMS and provides timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ SOP. • Follows up on outstanding actions with study sites to ensure resolution in a timely manner. • Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required. • Assists site in maintaining inspection ready ISF. • Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and CQAD. • Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH GCP, AZ SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. • Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc) are available and ready for final archiving and completion of local part of the eTMF. • Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. • Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment). • Ensures compliance with local, national and regional legislation, as applicable. • Collaborates with local MSLs as directed by LSAD or line manager. For LSAD activities, refer to and acknowledge LSAD Job Description. 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. If you’re curious to know more then please reach out to (contact person) We welcome with your application, no later than (Month) (XX) 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 05-Nov-2025 Closing Date 14-Nov-2025 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 is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

The Senior Specialist Study Management is responsible for managing study sites, ensuring compliance with regulatory requirements, and supporting investigators and site staff. This role involves monitoring study progress, resolving issues, and maintaining inspection readiness throughout the study lifecycle.