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Clinical Data Manager

Employer
GSK
Location
Warren, New Jersey
Salary
Competitive
Closing date
Jun 28, 2022

View more

Discipline
Physical Sciences, Information Technology
Job Type
Manager
Organization Type
Pharma
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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…
  • 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)


Why you?

Basic Qualifications:

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



Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • 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


Why Consumer Healthcare?

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

*LI-GSK

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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