Manager, Clinical Data Manager

2 weeks ago


Mississauga, Canada GSK Full time

**Site Name**: USA - Pennsylvania - Upper Providence, Canada - Ontario - Mississauga

**Posted Date**: Nov 1 2023

We are looking for quick learning, open minded and independent Clinical Data Manager who will be a part of the Data Management group within our constantly growing GSK R&D team. The Manager, Clinical Data Management is responsible for overseeing end-to-end Data Management study related activities and is accountable for all DS&M study deliverables in terms of quality & delivery to plan. This role could mentor others within the DS&M team and act as a Subject Matter Expert.

We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

Find out more: Innovation | GSK

In this role you will Be accountable for the end to end DS&M study related activities in terms of quality & delivery to plan which include:

- Electronic Case Report Form and (electronic) Diary Cards & other clinical outcome assessments
- Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation
- Interim and final cleaned database lock
- Archival of all DM documents in the eTMF
- Archival of the study database and provision of clinical data to the study site
- Be accountable for one or several complex studies, and has the ability and experience to manage the delivery of any type of study (different therapeutic areas, complex/unusual early phase setting, new/unusual indication, pivotal/Phase III and efficacy studies, clinical as well as epidemiology studies)
- For an in-house study, lead the day to day DS&M operational study related activities, acts as a member of the study core team and is the single point of contact for all the DM study related activities & matters
- For a study outsourced through a DM Functional Service Provider (FSP) or Full Services Outsourcing (FSO), conduct & document sponsor oversight of the end to end FSP/FSO study related activities and ensures training on the protocol to the FSP resources working on the study
- Provide DM operational input into the study design, the protocol, study planning, study documents including the study risk register
- Provide reports, status updates, feedback and advice to key study stakeholders on study progress.
- Potentially oversee and provides input to the development of budgets forecasts for FSP and FSO contracts.
- Create or review study level timelines for DM deliverables and ensures teams adhere to these - Promote the implementation of clinical data standards to increase consistency, efficiency & productivity
- Act as the first point of escalation for all DM study issues.
- Understand, mediate and solve issues related to DM study deliverables and escalates as required to DM representative at Asset level
- Ensure DM study deliverables are in compliance with GSK SOPs and regulatory guidelines
- Develop and maintains excellent professional relationships with study team and other key stakeholders
- Act as a mentor for junior members of the DS&M team Act as a Subject Matter Expert supporting the implementation of new processes, data standards, trainings, systems, vendor quality assessments, audits and inspections

Why you? Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:

- BSc/Bachelor’s degree in a Scientific or Business discipline
- 3+ years experience working in Clinical Trials in either a Pharmaceutical or CRO environment
- 3 + years experience working with global suppliers/ partnerships to ensure deliverables are to the agreed standard Electronic Case Report Form and (electronic) Diary Cards & other clinical outcome assessment

Preferred Qualifications:

- Demonstrable experience of the project management to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets
- Supports capability build across the function
- Builds influential networks within the organization & study team members. Uses these relationships to generate buy-in and support for the project, Data Management Plan or equivalent, to ensure mutually advantageous resources and goals

LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

**Why Us?**

GSK is a global biopharma company with a special purpose - to unite science, technology and ta


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