Clinical Data Manager, Open to flexible working
2 days left
- Contract Type
Are you a Clinical Data professional seeking your next challenge in your career? If so, the Clinical Data Manager role here at GSK could be the perfect opportunity for you!
As the Clinical Data Manager you will be responsible to deliver the data management components of a series of clinical studies or project from data capture from multiple sources, through improving in-stream data flow, data cleanliness and data integration. Your responsibilities will include some of the following:
- Study level contribution as Study Data Manager (SDM) or in close collaboration with SDM and other members of the study team.
- Point of contact for data management and data quality considerations.
- Provides 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.
- Manages/supports in managing in-stream data flow activities and delivers a clean database in accordance with the Data Management Plan or equivalent.
- Inputs into the data capture tools for a clinical study, including the eCRF and eCOA.
- Provides input into the development and aids in the management and execution of the validation and integration plans, including dataset definitions and external data sources. Manages vendor performance against study-specific Service Level Agreements.
- Responsible for the set-up and maintenance of TMF section 10 and DM TMF artefacts throughout the study life cycle.
- Trains monitors and site staff on use of data collection tools and query management process
The job holder needs to be tenacious and have a strong performance mindset – driving for results through an understanding of drivers of the business and has an ability to focus on the things that make a difference and get things done. To achieve this the job holder needs to have:
- Bachelor’s Degree
- Pharma, CRO and/or ARO experience.
- Understanding of disease area.
- Understanding of laboratory data.
- Understanding of applicable ICH/GCP regulations
- Clinical trial experience.
- Experience working with key global preferred suppliers/ partnerships to ensure deliverables are to the agreed standard.
- Demonstrates the discipline of project management to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigor and risk
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
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, colour, 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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