Senior Associate, Data Management
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Job description
About the Position
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.
Responsibilities
- 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
Requirements
- Bachelor’s degree or equivalent, preferably in a scientific or IT related discipline. Advanced degree or diploma preferred.
- Fluent English (oral and written)
- 1 to 3 years prior data management or successful completion of at least 1 year as Associate 1, Data Management (or equivalent).
- 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.
We Offer
We strive to provide our employees and their families with benefits that are thoughtfully designed to enhance your health and well-being. Our employees enjoy half-day Fridays, paid time off, paid holidays, extensive country specific benefits, employee bonus programs, career growth, training and development.
About the Company
Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
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Biorasi Headquartered in Aventura, Florida, with regional offices and operations across North America and around the world,Biorasi is an award-winning fast growing, full-service, global CRO that delivers Clinical Research OptimizedTM to the world’s leading biotech and pharmaceutical companies.Biorasi hires talent and personality, not position holders. We’re a non-traditional work environment requiring only top performers. Every team member is an equity-holding owner and our culture reflects it.Unlimited potential for professional, financial and personal growth. If you are after broad and growing responsibilities coupled with full authority, are keen on doing the job your way, without bureaucracy getting in the way of key decisions, and truly believe that a well-structured operational infrastructure is one of the key components to a company’s success, then this unique opportunity is for you.This is a remarkable opportunity to dedicate yourself to leading a vital function of a growing company and benefiting professionally and financially from your accomplishments. If you have an entrepreneurial mind-set, a passion for achievement and are looking for a place to explore your potential, Biorasi wants to talk to you now.