Manager, Clinical Data Management

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery.  We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.

Find out more:

Our approach to R&D.   

The Manager, Clinical Data Management is responsible for overseeing the end to end DS&M study related activities and is accountable for all DS&M study deliverables in terms of quality & delivery to plan.  This role mentors other DS&M team member(s) and acts as Subject Matter Expert.

Manager, Clinical Data Management

 Key responsibilities:

• Being 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

• Demontstrating 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)
• Leading the day to day DS&M operational study related activities, acts as amember of the study core team; being the single point of contact for all the DM study related activities & matters
• Providing DM operational input into the study design, the protocol, study planning, study documents including the study risk register
• Reporting to key study stakeholders on study progress.
• Promoting the implementation of clinical data standards to increase consistency, efficiency & productivity
• Acting as the first point of escalation for all DM study issues.
• Ensuring DM study deliverables are in compliance with GSK SOPs and regulatory guidelines
• Developing and maintaining excellent professional relationships with study team and other key stakeholders
• Acting as a mentor for junior members of the DS&M team
• Acting as a Subject Matter Expert supporting the implementation of new processes, data standards, trainings, systems, vendor quality assessments, audits and inspections

Why You?

Necessary skills:

We are looking for professionals with these required skills to achieve our goals:

• University Degree, in scientific or business discipline
• Pharma and/or CRO experience.
• Understanding of disease area, laboratory data, and applicable ICH/GCP regulations, GSK policies and SOPs
• Experience working with global suppliers/ partnerships to ensure deliverables are to the agreed standard
• Effective verbal and written skills to communicate project related activities (e.g., study core team meetings, Risk Registers, Data Management Reports, Data listings review, post analysis meeting)
• Ability to work effectively with global cross-functional teams and influence multidisciplinary teams

Why GSK?

• Career at one of the leading global healthcare companies
• Contract of employment
• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
• Life insurance and pension plan
• Private medical package with additional preventive healthcare services for employees and their eligible
• Sports cards (Multisport)
• Possibilities of development within the role and company’s structure
• Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
• Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)
• Supportive community and integration events
• Modern office with creative rooms, fresh fruits everyday
• Free car and bike parking, locker rooms and showers.

Inclusion & Diversity at GSK: 

Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process. We want you to be you, feel good and keep growing your career. GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. Beyond this, we commit to our values of integrity and respect towards every applicant.

We want to hear from you and support with any adjustments that you may require during the recruitment process.

Please get in touch with our Recruitment Team (pl.recruitment-adjustments@gsk.com) to further discuss this today.

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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.

GSK is an Equal Opportunity/Affirmative Action Employer. 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.

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