Clinical Data Manager

 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  
• Two or more years of experience with general data flow & database architecture concepts  
• Two or more years of experience with clinical drug development process and regulations including ICH-GCP, 21 CRF part 11, CDISC requirement 
• Two or more years of 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 
• Fluent in written and spoken English
• Proven ability to prioritize and multi-task, along with effective time management skills  

Why GSK?

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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 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. 

#LI-GSK

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.

GSK is an equal opportunity employer committed to diversity and inclusion.  We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com.  Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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