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Senior Associate, Data Management - Hybrid, Mumbai

2-4 years
Not Disclosed
10 Sept. 30, 2024
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Join Our Growing Team at Biorasi!

At Biorasi, we’re excited to support your career journey in an innovative, collaborative, and dynamic environment. As an award-winning, customer-focused full-service clinical research organization, we leverage your strengths while promoting a healthy work-life balance.

We are looking for top performers who share our passion for clinical research—whether you're a seasoned trial veteran or a newcomer eager to thrive in our fast-paced setting. This is your chance to be a vital part of a global company making strides in the clinical research industry.

Your Role:

  • Data Management: Perform data cleaning procedures and conduct regular reviews of EDC queries, including issuing and resolving queries.
  • Documentation Development: Create data management listings, data management plans, data validation plans, and system validation plans.
  • User Access Management: Maintain user access to study systems, ensuring compliance with 21 CFR Part 11.
  • Vendor Coordination: Participate in vendor data reconciliation.
  • Database Administration: Under supervision, assist in the design, setup, and administration of databases (EDC).
  • Validation Specifications: Develop database validation specifications, CRF Completion Guidelines, and User Acceptance Testing (UAT) scripts.
  • User Acceptance Testing: Conduct UAT for study databases.
  • Documentation Archiving: Prepare, collect, and archive study-related clinical documents and TMF activities.
  • Database Lock Assistance: Support database lock processes and the completion of final study reports.
  • Audit Support: Assist with departmental audits and compliance requirements as needed.
  • Reporting: Generate data management reports.
  • Program Development: Develop and review programs and databases for clinical trial data management.
  • Help Desk Support: Respond to EDC help desk requests.
  • Project Management Assistance: Provide support for project management requests as needed.
  • Additional Duties: Perform other data management responsibilities as assigned.

Your Profile:

  • Education: Bachelor’s degree (or equivalent) in a scientific or IT-related discipline; advanced degree or diploma preferred.
  • Language Skills: Fluent in English (oral and written).
  • Experience: 2 to 4 years of prior data management experience.
  • Regulatory Knowledge: Familiarity with FDA, ICH, and GCP guidelines.
  • Technical Skills: Proficient in MS Office and computer literacy.
  • Organizational Skills: Excellent organizational abilities.
  • Communication Skills: Strong verbal and written communication skills.
  • Attention to Detail: Ability to maintain meticulous attention to detail.

If you meet the qualifications and want to be part of an energetic, creative, and collaborative team, please apply directly on our website at Biorasi Careers or email us at careers@biorasi.com.

Employee Benefits:

We prioritize the well-being of our employees and their families, offering thoughtfully designed benefits, including half-day Fridays, paid time off, paid holidays, country-specific benefits, employee bonus programs, and opportunities for career growth and development.

Commitment to Diversity:

Biorasi is dedicated to fostering 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. We also adhere to fair employment practices regarding citizenship and immigration status.

Join us in advancing the future of clinical research!