Data Lead (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  

In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD112,000 to CAD162,000 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our recruitment process.Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

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