Site Name: Warsaw
Posted Date: Dec 21 2020
GlaxoSmithKline is one of the leading global healthcare companies, driven by innovation and scientific developments. Our mission is to improve the quality of life, enabling people to do more, feel better and live longer. We conduct research aimed at improving the quality of life in three basic areas: Pharmaceuticals, Vaccines and Consumer Healthcare. In our activities, we strive to be a responsible partner, building trust-based relations with healthcare system participants, focusing on dialogue and transparent cooperation.
We are looking for experienced Study Data Manager, who will be a part of the Data Management group within GSK R&D Polish Hub. Main role's purpose it to deliver the data management components of a series of clinical studies or projects from data capture from multiple sources, through improving in-stream data flow, data cleanliness and data integration.
Study Data Manager role is located in Warsaw.
- Oversight/direction of end-to-end data management for a series of studies, delivered by DM Functional Service Provider (FSP).
- Mentoring / training of Study Data professionals.
- Study level contribution as Study Data Manager (SDM) or in close collaboration with other members of the study team.
- Point of contact for data management and data quality considerations.
- Providing input to protocol and other plans, e.g. Monitoring Plan, Protocol Deviation Management Plan, Reporting & Analysis Plan and Data Management Plan (or equivalent), during the planning phase.
- Management/support in managing of in-stream data flow activities, delivering a clean database in accordance with the Data Management Plan or equivalent.
- Input into the data capture tools for a clinical study, including the eCRF and eCOA devices and vendor data.
- Providing input into the development and aid in the management and execution of the validation and integration plans, including dataset definitions and external data sources.
- Managing vendor performance against study-specific Service Level Agreements.
- Responsibility for the set-up and maintenance of TMF section 10 and DM TMF artefacts throughout the study life cycle.
- Training monitors and site staff on use of data collection tools and query management process.
- Where a study is outsourced to FSO/FSP partner, providing oversight and assuring FSO/FSP partner delivers to agreed quality, timelines and cost.
What skills and expertise you will bring to the role:
- Master's or Post-Graduate Degree in Scientific Discipline (Biomedical or Computer).
- Min. 5 years of data management experience in Pharma, CRO and/or ARO experience.
- Experience in Oncology disease area.
- Clinical trial experience.
- Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP).
- Knowledge of CDISC requirements for data capture and reporting.
- Fluent English, both spoken and written.
- Understanding of laboratory data including biomarker data.
- Understanding of applicable ICH/GCP regulations and applicable GSK policies and SOPs.
- 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.
- Demonstrated discipline of project management to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets.
- Good communication skills, verbal and written, ability to effectively communicate and maintain strong working relationships in global teams at all levels of the organization.
- Result-driven, proactive, detail-oriented, problem solver.
How you will be rewarded:
- Joining a high performing, business-supporting team of professionals in a global Data Management team.
- Career with purpose - whatever it is you're doing, you'll be sharing our mission to improve the quality of human life, by enabling people to do more, feel better and live longer.
- Career in leading global healthcare company with modern employer mindset, corporate culture and values.
- Opportunity for professional development and acquiring new skills set in a top-level professional environment.
- Access to newest technologies and solutions.
- Supportive & friendly working environment.
- Competitive salary, bonus plan and healthcare benefits.
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/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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