Associate II, Data Management
3 weeks ago
About the job
We are Growing Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization.
Biorasi is looking for top performers who are as passionate about clinical research as we are clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.
Your role:
- Perform data cleaning procedures, maintenance review of EDC queries, including query issuance and resolution
- Develop data management listings, data management plans, data validation plans and system validation plans.
- Maintain user access to study systems, ensuring compliance with 21 CFR 11.
- Participate in vendor data reconciliation.
- Perform, under supervision, database (EDC) design, setup and administration.
- Develop database validation specifications, CRF Completion Guidelines, User Acceptance Testing scripts of data for study databases.
- Perform User Acceptance Testing for development study databases.
- Prepare, collect, and archive study related clinical documents and TMF activities.
- Assist with database lock and the completion of final study reports.
- Assist with departmental audit and compliance requirements as needed.
- Develop data management reports.
- Develop and review programs and databases for management of data from clinical trials.
- Respond to EDC help desk requests.
- Assist with Project Management requests as requested.
- Other data management duties and responsibilities as assigned
Your Profile:
- Bachelors degree or equivalent, preferably in a scientific or IT related discipline. Advanced degree or diploma preferred.
- Fluent English (oral and written)
- 2 to 4 years prior data management experience.
- Knowledge of FDA, ICH, and GCP guidelines.
- Computer literacy, proficiency in MS Office.
- Excellent organizational skills.
- Strong verbal and written communications skills.
- Ability to exercise excellent attention to detail.
Please use the below link for job application and quicker response.
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