Study Manger - Bengaluru, India - GSK

GSK

Verified Company

Bengaluru, India

2 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

Site Name:
Bengaluru Luxor North Tower

Posted Date:
Dec 1 2023

Delivery of study to plan, including managing the study team's communication/meetings, tracking progress and the monitoring/assessment of risks to timeliness or quality of study delivery
Preparation and update of study documents and study plans (incl CSAP), including study protocol, Monitoring Plans, Vendor Management Plans, Protocol Deviation Management Plans, Risk Management Plans, Communication Plans etc.
Local Operating Companies liaison / oversight including tracking of recruitment progress, data completeness and compliance, local budget oversight, protocol deviations oversight, supplies' availability, regulatory approvals and import license status
Vendor management & CRO oversight agreeing on studyspecific setup requirements, ensuring continued monitoring of agreed delegated activities
Supporting SDL in quality and data oversight to ensure inspection/audit readiness, including oversight of eTMF completeness
Setting up and maintaining clinical trial management systems and tracking tools that ensure quality, consistency and integration of study data, following up on discrepancies if needed
Risk management contribution to maintenance of a comprehensive risk management plan and risk tracking
Clinical supplies and recruitment materials management having oversight on study level supplies availability, recognizing and communicating issues to continuity of supplies, proposing solutions as appropriate
Coordination of the study budget including support to contract management for vendors, managing expenses, tracking updates, checking consistency between systems and agreements and escalating issues
Providing input to develop study specific processes and procedures, adhering to standardization and dissemination of best practices
Providing support to departmental initiatives and objectives, including for example support, training/mentoring as required

Why Us?

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 organization where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.

We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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.