Central Monitor - 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:
Feb

Endtoend clinical development/operations experience;
Business acumen demonstrated by understanding of risk management, problemsolving, the implications of decisions and uses this knowledge to plan and manage issues, projects and processes
A minimum of 35 years drug development experience in Pharma, relevant CRO and/or ARO
Understanding of various local regulatory environments
Previous international/above country work preferred but not mandatory
Understanding and compliance with ICH GCP, and applicable GSK Pharma R&D policies and SOPs.
Understanding of RBM, use of data analytics (e.g. Spotfire RBM Tool) and Risk Based Quality Management (RBQM)
Strong knowledge/experience in project management and matrix team interactions
Strong communication/negotiation/facilitation/influencing/coaching skills
Oncology experience would be advantageSupports the Central Monitoring Lead in the studyspecific setup and ongoing maintenance of the data analytical tool used for centralized monitoring
RBM data analytical tool expert for conducting data risk review, risk and issue management
Participates in the training of central and local study teams on RBQM and central monitoring processes
Performs centralised monitoring of study data and maintains oversight of study/country/site risk parameters according to the study monitoring plan
Identifies data quality trends indicative of systematic errors and potential study/country/site performance issues
Communicates to relevant study team members trends/findings, implications and recommends actions within data analytical tool and provides regular status reports to study team
Ensures the proper documentation & archiving of instream data reviews, risk and issue management
Shares the responsibility for data quality at the study, country and site levels
Understanding of RBQM, RBM and CM demonstrates a current, indepth understanding of ICH E6R2 revisions and how determining monitoring approaches, including centralized monitoring is important for delivery of accelerated quality clinical trials
Demonstrates understanding and importance of risk management and data driven decision making to improve the effectiveness and efficiency of E2E quality clinical trial monitoring to support GSK study delivery strategy.
Given the interactions with multidisciplinary teams proven experience in project management, trial execution and delivery, are essential.

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.

Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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.

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**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.