Central Statistical Monitor

Central Statistical Monitor

GlaxoSmithKline Pte Ltd
1-3 years
Not Specified

Job Description


Job Description :
Site Name: Bengaluru Luxor North Tower Posted Date: Nov 10 2021 Are you energized by a clinical education role that allows you to build industry-leading medical capabilities through an integrated professional development framework If so, this Clinical Support Manager role could be an exciting opportunity to explore. Catalyst for Risk Based Quality Management (RBQM) where Centralized Monitoring and Data Analytics are implemented in GSK clinical trials. From study start through to study Data Base Freeze, conducts holistic and centralized statistical review of study data according to the study Monitoring Plan, uses data analytical tools to identify emerging and existing risks to critical study data and process. Enables proactive identification, communication, escalation and management of risks at the study/country/site level. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Performs centralised statistical monitoring of instream study data focussed on identification of inconsistent data, unexpected lack of variability, data trends and unusual data distributions within and across sites . Identifies data quality trends indicative of systematic errors and potential study/country/site performance issues . Supports the Central Monitoring Lead in the study-specific set-up and ongoing maintenance of the data analytical tool used for centralized statistical monitoring . RBM data analytical tool expert for conducting central statistical review . Works with Central Monitors to document observations/findings, implications and actions within the data analytical tools and provides status reports to be shared with study teams . Shares the responsibility for data quality at the study, country and site levels Why you Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: End-to-end clinical development/statistical experience . Understanding of RBM, use of CSM/Data Analytics and Risk Based Quality Management (RBQM) and their impact on data integrity . Business acumen demonstrated by understanding of risk management, problem-solving, the implications of decisions and uses this knowledge to plan and manage issues, projects and processes . A minimum of 1-3 years central statistical monitoring experience in drug development . Understanding of various local regulatory environments . Understanding and compliance with ICH GCP, and applicable GSK Pharma R&D policies and SOPs. . Strong communication/influencing skills . Oncology experience would be advantage Why GSK Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. GSKIndia_RD *LI-GSK Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. 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 GlaxoSmithKilne (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in 'gsk.com', you should disregard the same and inform us by emailing [Confidential Information], so that we can confirm to you if the job is genuine.

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