Clinical Data Manager - Mississauga, Canada - GSK

GSK

Verified Company

Mississauga, Canada

5 days ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Site Name:
Canada - Ontario - Mississauga

Posted Date:
Apr

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 inhouse study, leads the daytoday 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 endtoend 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
Resultdriven, proactive, detailoriented, problem solver
Willing to work in a Global environment
Fluent in written and spoken English
Proven ability to prioritize and multitask, along with effective time management skills

_ Why 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 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 Us?

Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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.

**Important notice to Employment businesses/ Agencies