What are the responsibilities and job description for the Data Lead (Clinical Data Manager) position at GSK?
Posted Date: Nov 21 2022
As Clinical Data Manager you will be responsible for overseeing the end-to-end DM study related activities and is accountable for all Data Strategy & Management (DS&M) study deliverables in terms of quality & delivery to plan.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
For an in-house study, leads the day-to-day DS&M operational study related activities, acts as a member of the study team and is the single point of contact for all the DM study related activities & matters
For study outsourced through a DM Functional Service Provider (FSP), conducts & documents DM sponsor oversight of the end-to-end FSP study related activities and ensures training on the protocol to the FSP resources working on the study. May oversee Full Service Outsourced (FSO) studies
Provides DM operational input into the study design, the protocol, study planning, study documents including the study risk register
Provides reports, status updates, feedback and advice to key study stakeholders on study progress
Creates or reviews study level timelines for DM deliverables and ensures teams adhere to these
Promotes the implementation of clinical data standards to increase consistency, efficiency & productivity
Acts as the first point of escalation for all DM study issues. Understands, mediates and solves issues related to DM study deliverables and escalates as required to DM representative at Asset level
Ensures DM study deliverables are in compliance with GSK SOPs and regulatory guidelines
Why You?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor's degree from Scientific Discipline (Biomedical or Computer)
1 to 3 years' experience of data management/clinical trials experience in Pharma, CRO and/or ARO
Fluent in written and spoken English
Experience with general data flow & database architecture concepts
Experience with clinical drug development process and regulations including ICH-GCP, 21 CRF part 11, CDISC requirement
Experience working with industry principles of quality, safety, risk management and compliance (ICH and GCP).
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Excellent interpersonal and teamwork skills
Demonstrates adaptability and an agile mindset
Result-driven, proactive, detail-oriented, problem solver
Willing to work in a Global environment
Proven ability to prioritize and multi-task, along with effective time management skills
Why GSK?
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
#LI-GSK
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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