Medical Operations Associate

**MEDICAL OPERATIONS ASSOCIATE - SINGAPORE (12-month contract)**

**ABOUT ASTRAZENECA**
- AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation 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._ _We are on a journey to bring life-saving medicines to patients. Our role in contributing to decreasing mortality rates globally is clear - shaping the future by spotting a scientifically-led commercial opportunity and acting now to operationalise and scale it._

**BUSINESS AREA -** **Singapore Marketing Company, Medical Affairs**
- At AstraZeneca we fuse the worlds of Medical and Commercial to spot opportunities and pioneer approaches that better serve our patients. _
- With a strong foundation of science and ethics, we run fast but never compromise on doing the right thing. Working at pace in our ever-changing, ambiguous markets takes creativity and imagination. We always feel supported to do this, learning from our failures and working as a team to win together._

**What you’ll do**
- You will be responsible for the performance Site Management & Monit_oring (SMM) Clinical trials, IITs/ESRs and RWEs performance with the objectives of timely delivery of data which is compliant with AZ Procedural Documents, ICH-GCP and local regulations, and delivery of a study management service across clinical studies from study start up until publications/final study report. You will act as_ QPPV deputy and be accountable for AZ’s compliance with prevailing regulatory requirements governing the conduct of pharmacovigilance, namely maintaining the AZ PV system as relevant for products approved in the marketing company, having oversight on the safety profiles and any emerging concerns in relation to the medicinal product for which AZ holds the marketing authorization in the marketing company._
- SMM Responsibilities_
- _ Works as part of a Medical Affairs team providing support, guidance and advice on a local level for study matters._
- _ Ensures the processes for study delivery are executed through the development of study reports._
- _ Has a keen understanding of the AZ processes and systems for the management of all trial related matters._
- _ Trains the medical team on the proper conduct of studies and audits the various trial management and conduct._
- _ Manages external approvals for all studies & the study drug supply for all trials/clinical studies._
- _ Works with local SMM study managers as appropriate to optimize the performance of the local study team(s) at country level._
- _ Perform clinical and operational feasibility assessment of potential studies to the highest quality. Contributes to site selection process by identifying potential sites/investigators_
- _ Contributes to patient recruitment strategy including ad-hoc communication with participating Investigators as necessary._
- _ Develops existing tools and processes to identify areas of improvement and ensures business continuity for study delivery._
- _ Supports SMM in different local initiatives as agreed with the Medical Director and Country Head SMM._
- _ Optimising SMM efficiency with respect to local initiatives which enhance performance_
- ESR Responsibilities_
- _ Coordinate and facilitate the LREG for all submitted ESR proposals, protocols, and protocol amendments_
- _ Document LREG discussions and review outcomes, before uploading into the ESR Operations System (Attachments Tab)_
- _ Document GREG discussions and review outcomes, before uploading into the ESR Operations System for protocol approval (Reviews Tab)_
- _ Operational support for all ESR, ensuring compliance with all applicable Company policies, processes/procedures_
- _ End user support and training in the ESR process and use of the ESR Operations System_
- _ Collaborate with the MEOR/OBU Operations Team to ensure the performance and milestones of the ESR are periodically assessed to verify the Sponsor/Sponsor-Investigator is achieving the deliverables as outlined in the RA/MTA_
- _ Responsible to archive all the study related documents from the LREG till Publications/Close-out in the ESR Operations System_
- _ Coordinate the study drug supply for ESR/IITs._
- _ Supports audits and regulatory inspections, according to the company policies, as required_
- _ Monitor the monthly ESR bulletin and follow-up on action items/Quarterly traffic lighting assessment with respective MA/MSL and PIs as required._
- _ Ensure with the medical contact that the study has been published appropriately_

Real World Evidence Studies
- _ Provide guidance on regulatory and operational matters for the studies to be conducted in Singapore._
- _ Track the progress of all the studies and adherence to milestones_
- _ Ensure with the medical contact that the study has been published appropriately_

Deputy QPPV Responsibilities