Study Delivery Associate

1 week ago

Bengaluru Karnataka, India GSK Full time

**Site Name**: Bengaluru Luxor North Tower
**Posted Date**: Sep 9 2024

**VEO Study Delivery Operations**

Value Evidence and Outcomes (VEO) delivers evidence that demonstrates the safety and value of our medicines. VEO is an essential contributor to medicines development and commercialization. VEO builds a deep understanding of patient populations, patient, payer, and provider needs and develops Value Evidence Plans that describe how those needs and associated challenges will be resolved. VEO also supports global franchises and regional and local teams to ensure that local evidence requirements are met.

**Key Responsibilities**:

- Study Deliver Associate (SDA) will provide operational support in evidence generation projects/studies to the Value Evidence Outcomes (VEO) Department as per the Study Delivery operating model in compliance with GSK operating standards, procedures (SOPs) and good clinical practice in partnership with the Study Accountable Person (SAPs).
- Work with GSK contracting groups and SAPs to review and submit contracts; facilitate contract execution, Procurement, RFP, purchase order requesting and contract execution aspects of the activities and liaise with vendors., including External Expert Engagement, due diligence form completion and support with resolving complex issues.
- Assist the SAPs to working with finance in resolving invoice issues and assis ing with supplier set up for Vx studies.
- Assist in drafting and finalizing the confidential disclosure agreements.
- Assist in setting up the EAP portal and make it easier for both internal and external users to request access.
- Responsible for documentation of VEO operations which includes tasks as EDL customization, Veeva TMF filing and completeness checks at key milestones, creation, maintenance, and completion of the VEO Study Document List (SDL), GCMS filing, SDL quality review procedure and study archival.
- Ensure compliance with ICH/GCP & ENCePP guidelines and/or applicable guidelines for VEO studies such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations for all products and services delivered for their designated studies.
- Ensure activities are registered correctly in GSK enterprise systems, in collaboration with central business groups supporting those systems and processes and with other members of VEO Business Operations.
- Ensure that VEO activities remain compliant with relevant GSK procedures, remaining up to date with
- all relevant training and seeking learnings and best practice from other GSK teams and external organizations, to develop best practice and innovation in study operations.
- Communicates timely and via relevant channels to ensure successful SD operations in VEO.

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

**Important notice to Employment businesses/ Agencies**

**GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.

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