This Clinical Data Manager
provides expert Data Management (DM) support and project management for DM activities in relation to clinical trials executed by the Consumer Healthcare
division in multiple categories. This role is accountable for the successful execution of the delegated projects for designated categories/sub-categories. This position involves oversight of studies where the Data Management execution activities are outsourced to Third Party Vendors.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Why you? Basic Qualifications:
- Accountable for delivery of Data Management (DM) for the categories/studies of responsibility
- Directly works with GSK study teams to correctly understand the DM requirements for CLINICAL TRIALS in their area of responsibility
- Providing Third Party oversight of strategic and tactical partners as related to area of responsibility including input into study documentation and maintenance of study specific oversight plans
- Review of Third Party task orders, change orders and invoices, as appropriate
- DM oversight for regulatory submissions
- Deliver expert technical knowledge and leadership to the business for DM activities, helping to ensure best practice and achievement of business objectives based on science and values
- Lead or provide input in departmental initiatives
- Stay current on technical advances in relevant field
- Design data collection modules, including core standards, therapeutic area standards, or study specific modules
- Apply design, data collection and technology expertise to daily work, and deliver against clinical protocol.
- Enabling clinical data reuse through common data models (e.g. CDISC)
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in Science, Biology, or related discipline
- 3 + years experience in leading the data management activities in multiple therapeutic areas and multiple projects
- Experience setting up third party vendors and providing oversight for DM activities
If you have the following characteristics, it would be a plus:
Why Consumer Healthcare?
- Master's degree
- Preferred Knowledge of Industry standards such as ICH, CDISC, data capture systems and requirements of regulatory authorities
- Strong understanding of CDISC standards and applicability to clinical database design capture and reporting
- Experience developing programming scripts using either SAS, R, or Python
- Excellent influencing skills, which are applied effectively at all levels of the organisation and across functional boundaries, especially at the senior management level
- Exceptional verbal and written communication skill
- Strong teamwork
Right now, we're on an incredible journey as we prepare to become the first independent, 100% focused consumer healthcare company. We're doing this at a time when the work we do has never mattered more. Better everyday health is about improving the health and wellness of the consumers that we touch every year - over a billion and a half of them - and it goes beyond products. It's about truly helping people manage their health proactively in different ways as consumer needs evolve. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we're uniquely placed to do this and to grow a strong, successful business. This is an exciting time to join us and help shape the future. It's an opportunity to be part of something special.Diversity, Equity and Inclusion
In Consumer Healthcare we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.
We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.
NOTE: this position can be located in Warren NJ - US or Weybridge - UK and can be a hybrid working situation
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