- 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
- 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
- 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
Sr. Clinical Data Manager - Mississauga, Canada - 837 GlaxoSmithKline Inc.
Description
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 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:
Why you? Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
Preferred Qualifications:
#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.
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