At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. Making the impossible a reality can mean taking a chance on an idea and investing in our exceptional capacity for innovation and discovery. We champion trying new things, and we nurture a test and learn culture that means we are always progressing close to our goals. If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us.

Typical Accountabilities

• Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations both in Trial Master File (TMF) and Investigator Study File (ISF). 
• Actively participate in Local Study Team meetings.
• Contribute to the selection of potential investigators.
• Train, support and advice Investigators and site staff in study related matters.
• Contribute to national Investigators meetings.
• Initiate, monitor and close study sites in compliance with AZ Procedural Documents. Share information on patient recruitment and study site progress within Local Study Team.
• Drive performance at the sites. Proactively identify study-related issues, solutions and escalates as appropriate.
• Update IMPACT and other systems with data from centres as per required timelines.
• Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
• Perform source data verification according to SDV plan.
• Ensure data query resolution by the site.
• Ensure accurate and timely reporting of Serious Adverse Events by the site.
• Prepare for activities associated with audits and regulatory inspections in liaison with local
• Study Delivery Team Lead and CA&A.
• Provide the required monitoring visit reports within required timelines. 
• Work with Data Management to ensure quality of the study data.
• Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
   

Additional Responsibilities May Include

• Ensure timely delivery of proper applications/documents for submission to Regulatory Authorities.
• Ensure timely customization and completion of the CSA for designated studies
• Design draft budget for designated studies according to fSMA requirements
• Track and manage agreed payments at study site level.
• Participate in training and mentoring of new members of the Local Study Team ensuring compliance with ICH/GCP and AZ Procedural documents.
• Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
• Contribute to process improvements, knowledge transfer and best practice sharing.
• Actively share applicable information that may be relevant to Marketing & Sales and the MC Medical Department and in accordance with Corporate 

Education, Qualifications, Skills and Experience

• Education: qualified as a pharmacist, physician or a dentist. Data driven, highly scientifically oriented person.
• Experience: currently working as a CRA/Sr. CRA in a multinational pharmaceutical company or a multinational CRO. Currently responsible for on-site monitoring of phase 2/3 global clinical studies. Candidates from remote monitoring background will not be considered even if they have previous on-site monitoring experience.
• Passion for delivery and absolutely non-compromising attitude towards quality.
• Excellent communication skills, and passion to redefine the quality and efficiency standards.

Job Location- Bangalore. We are open to offer homebased positions in Mumbai, Delhi or Ahmedabad.

Salary- Competitive

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.