Senior Data Manager, Life Sciences
Oracle
Oracle Life Sciences is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Oracle Life Sciences, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research. Oracle Life Sciences is passionate about our people, our business, and our clients and is proud to foster a culture that contributes to the health and well-being of humankind.
As a global leader we’re looking for a Senior Data Manager to drive our customer success as part of our international Data Management team. Join us and create the future.
As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s challenges. We’ve partnered with industry-leaders in almost every sector—and continue to thrive after 40+ years of change by operating with integrity.
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Are you an experienced Senior Data Manager who enjoys analysing and presenting data? If you have extensive experience in this field, this is an incredible opportunity to excel in an exciting, dynamic environment!
Career Level - IC3
What you will do
As a Senior Data Manager, you will manage data for clinical trials and non-interventional studies (NIS), build and validate study databases, ensure compliance with SOPs/sponsor guidelines/regulations, oversee all end-to-end data management activities, ensuring deliverables on time and within budget, including budget and site reimbursement
Responsibilities include:
- Managing stakeholder relationships.
- Manage multiple studies simultaneously.
- Create and maintain Data Management study documents: eCRF/CRF, Data Management Plan, Data Validation Plan and Data Entry Guidelines.
- Design, program, and test study databases and edit checks; define data dashboards, listings, and reports.
- Review, clean, and validate data; manage queries; monitor data trends; perform (S)AE reconciliation and medical coding (MedDRA, WHO-DD).
- Perform QC and database quality assessments; maintain accurate records per SOPs and protocols.
- Set up and maintain project administrative structures, plan and coordinate data entry resources.
- Screen CRFs for adverse events; forward SAEs to Drug Safety.
- Manage study budgets, invoicing, deliver sponsor outputs on time.
- Train and support users on data capture systems; standardize data management procedures.
Required Experience
- Bachelor’s degree or equivalent relevant experience
- Minimum 5 years of experience in data management with international clinical trials and/or NIS, within a CRO environment preferred
- Knowledge of CDISC standards
- Good knowledge in medical coding
- Experience working with different EDC systems
- Basic knowledge and understanding of SAS and SQL
- Fluent in English
- Certified Clinical Data Manager is desired
What we will offer you
- A competitive salary with exciting benefits
- Learning and development opportunities to advance your career
- An Employee Assistance Program to support your well-being
- Flexible and hybrid working so you can do your best work
- Employee resource groups that champion our diverse communities
- Core benefits such as life insurance, and access to retirement planning
- An inclusive culture that celebrates what makes you unique