The Manager, Clinical Data Management (Senior Study Data Management Quality Leader (Sr DMQL)) 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.
Responsibilities:
Accountable for the end to end DS&M study related activities in terms of quality & delivery to plan which include:
o Electronic Case Report Form and (electronic) Diary Cards & other clinical outcome assessments
o Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation
o Interim and final cleaned database lock
o Archival of all DM documents in the eTMF
o Archival of the study database and provision of clinical data to the study site
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, leads 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), conducts & documents 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
Provides DM operational input into the study design, the protocol, study planning, study documents including the study risk register
Provides reports, status updates, feedback and advice to key study stakeholders on study progress.
May oversees and provides input to the development of budgets forecasts for FSP and FSO contracts.
Creates or reviews study level timelines for DM deliverables and ensures teams adhere to these.
Promotes the implementation of clinical data standards to increase consistency, efficiency & productivity
Acts as the first point of escalation for all DM study issues. Understands, mediates and solves issues related to DM study deliverables and escalates as required to DM representative at Asset level.
Ensures DM study deliverables are in compliance with GSK SOPs and regulatory guidelines
Develops and maintains excellent professional relationships with study team and other key stakeholders • Acts as a mentor for junior members of the DS&M team
Acts as a Subject Matter Expert supporting the implementation of new processes, data standards, trainings, systems, vendor quality assessments, audits and inspections
Why You?
What skills and expertise you will bring to the role:
Relevant education degree from Scientific Discipline (Biomedical or Computer)
Min. 5 years of data management/clinical trials experience in Pharma, CRO and/or ARO
Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP)
Fluent English, both spoken and written
Good communication skills, verbal and written, ability to effectively communicate and maintain strong working relationships in global teams at all levels of the organization
Demonstrated project management ability to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets
Understanding of laboratory data including biomarker data
Experience of InForm, RAVE and/or Veeva EDC systems will be an advantage
Experience working with key global preferred suppliers/ partnerships, to ensure deliverables are to the agreed standard
Why GSK?
What we offer:
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: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
Extensive support of work life balance (flexible working solutions, health & well-being activities)
Supportive community and integration events
Modern office with creative rooms, fresh fruits every day
Inclusion at GSK:
As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.
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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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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