Senior Analyst - Clinical Data Management
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Job Description
About the job
We are excited to be named one of the Worlds Best Workplaces by Fortune Magazine!
We are proud to offer you our total rewards package which includes bonuses healthcare insurance benefits retirement programs wellness programs as well as service and performance awards not to mention various social and recreational activities all of which are location specific.
Stryker is one of the worlds leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies including reconstructive medical and surgical and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Staff Biostatistician to join our Neurovascular division to be located in Gurgaon Haryana.
Who We Want
- Detailoriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes finding ways to simplify standardize and automate.
- Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning forecasting advising budgeting reporting or sales opportunities.
- Collaborative partners. People who build and leverage crossfunctional relationships to bring together ideas data and insights to drive continuous improvement in functions.
- Analytical problem solvers. People who go beyond just fixing to identify root causes evaluate optimal solutions and recommend comprehensive upgrades to prevent future issues.
- Dedicated achievers. People who thrive in a fastpaced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Qualifications and Experience
- 6 to 12 years of relevant experience
- Experience in Medical Devices preferred.
- Pharmacy Nursing or Medical Graduation Post graduation preferred
- Any Graduation with Clinical Research postgraduation
- Knowledge of clinical trial design and analysis preferred.
- Knowledge of regulatory guidelines (FDA/CFR; ISO14155) preferred.
- Experience supporting publication of analysis results (e.g. abstracts posters manuscripts) preferred.
- Experienced with electronic data capture (EDC) system(s) preferred.
- Excellent in both oral and written communications.
- Ability to explain basic statistical concepts to nonstatisticians.
- Good organizational and time management skills.
What You Will Do
- Data Review and Data Medical Review
- Identifying data related discrepancies such as missing data potentially discrepant and mismatching data with other fields
- Identifying the potential data discrepancies from medical and clinical perspective
- Medical and Product Coding collaborate with Medical Sciences for coding review and approval.
- Data Querying and Integrity Management
- Lead the data querying and completion process during data review
- Generate data discrepancy criteria and associated queries on the data review
- Develop and periodically publish data entry metrics and work closely with the Clinical Study Manager (CSM) to allocate resources based on priorities.
- Analyze the data by fields and identify trends and pattern to detect suspicious data activities
- Data cleaning
- Taking requisite actions on the nonstandard data Identified in data review process
- Coordinating with the CRAs for getting the data completed corrected and confirming the extreme or outlier values
- Develop complex status reports and utilize status reports to determine followup action.
- Base Data Management Process
- Coordinate Case Report Form (CRF) development review and approve final CRFs.
- Review and approve data entry screen shots during database development
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Remote Work :
No
Employment Type
Full Time
