Clinical Data Manager I
Roche
Summary
As Clinical Data Manager I, you will perform data management activities for both clinical studies and development projects as assigned. You ensure the delivery of complete, accurate data that is ready for analysis and regulatory submission. You support all data-related activities, including data entry, verification, and scribing when needed.
Job description
The Opportunity
As Clinical Data Manager I, you will perform data management activities for both clinical studies and development projects as assigned. You ensure the delivery of complete, accurate data that is ready for analysis and regulatory submission. You support all data-related activities, including data entry, verification, and scribing when needed.
- Support Lead Data Managers in execution of assigned tasks.
- Assist and contribute to the compilation of all data management documentation for assigned projects; review and adhere to the requirements of study-specific DMP; participate in study-specific data entry training and serve as backup to data entry staff.
- Prepare and enter test data for user testing of clinical database and edit checks.
- Perform basic clinical study data review as required; identify incomplete, erroneous, and/or discrepant data.
- Generate discrepancies and update clinical database based on queries, data clarification forms, discrepancy management guidelines, and perform other database changes as necessary for a study.
- Assist in preparation of relevant subject data files and study documentation for audits and quality control; perform other duties as assigned.
Who You Are
- You have a Bachelor's Degree
- Experience required: entry level with great communication skills and the ability to work with relevant computer software, including spreadsheets, word-processing and database packages
Behaviours, competencies and qualities of the ideal applicant
- Ability to work under time pressure while maintaining high standards of precision and data quality
- Experience with Python scripting, Java and SQL preferred.
Requirements
- Bachelor's Degree
- Entry level experience
- Great communication skills
- Ability to work with relevant computer software, including spreadsheets, word-processing and database packages
- Ability to work under time pressure while maintaining high standards of precision and data quality
- Experience with Python scripting, Java and SQL preferred
Benefits
- Annual bonus
- Medical, Dental & Vision
Company overview
Roche is a Swiss multinational healthcare company and a global pioneer in pharmaceuticals and diagnostics, founded in 1896 and headquartered in Basel, Switzerland. As the world's largest biotech company and the fifth-largest pharmaceutical company by revenue, Roche operates through two primary divisions: Pharmaceuticals and Diagnostics. The company is renowned for its leadership in personalized healthcare, combining strengths in both drug development and diagnostic testing to deliver tailored treatments for patients. Roche maintains a strong focus on oncology, immunology, infectious diseases, ophthalmology, and central nervous system disorders, with a portfolio that includes over 30 medicines on the World Health Organization's Model Lists of Essential Medicines. The company owns significant subsidiaries including Genentech, Chugai Pharmaceuticals, Ventana Medical Systems, and Foundation Medicine. With approximately 103,000 employees worldwide and operations in over 100 countries, Roche has established itself as a leader in cancer treatments globally while maintaining a robust pipeline of innovative therapies and diagnostic solutions. The company's commitment to sustainability has been recognized through ten consecutive years as Group Leader in the Dow Jones Sustainability Indices within the Pharmaceuticals, Biotechnology & Life Sciences Industry.