Assistant Clinical Data Analyst

Fortrea; Bengaluru; Sur place; INR 300 000 - 540 000; Plein temps

Résumé du poste

Fortrea in Bengaluru, India is seeking a Data Management Associate to support clinical data activities. The role emphasizes adherence to SOPs, timely trainings, and accurate data handling within the EDC environment.

The candidate should have a life sciences or related degree and 0-1 year of clinical research experience, with strong communication and organizational skills to ensure data quality and regulatory compliance.

Qualifications

• University/college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Responsabilités

• Follow SOPs and training timelines.
• Review queries and update the database as assigned.
• Work within Data Management operational data flows.
• Review reports and take actions as defined in the DMP/eCRF manuals.
• Perform consistency checks and data listings review as assigned.
• Ensure Data Management activities comply with regulatory requirements and GCP.
• Set up and maintain EDC user access accounts.
• Process user access requests accurately and efficiently.
• Troubleshoot and resolve EDC access issues; liaise with vendor when needed.
• Create, format and distribute User Access Reports for project managers.
• Assist with decommissioning/archiving tasks and ad hoc reporting.
• Carry out additional duties as needed.

Connaissances

Organizational skills

Communication

Attention to detail

Teamwork

Quality of work

Computer skills

Formation

University degree or allied health certification

Outils

EDC systems

Description du poste

Summary of Responsibilities:

• Follow applicable departmental Standard Operating Procedures and Work Instructions.
• Complete required trainings according to timelines.
• Within the specified timelines review and action queries on an ongoing basis and upon meeting the quality expectations update database appropriately, as assigned.
• Work as per assigned Data Management related operational data flows.
• Review reports and take actions as defined in the DMP or eCRF review manual, as assigned.
• Perform ongoing and final consistency checks, data listings review as defined in the DMP and eCRF Review Manual, as assigned.
• Ensure that all Data Management activities are conducted in compliance with relevant regulatory requirements and Good Clinical Practices.
• Setup and maintenance of EDC User Access Accounts for databases.
• Ensure EDC user requests for database access are completed accurately and efficiently.
• Troubleshoot and correct User access issues; follow up with EDC vendor for technical support as needed.
• Create, format, and distribute User Access Report to Project Managers/Lead Data Manager for reconcilication of User access.
• Assist with decommissioning/archiving tasks, generating reports and distributing reports and other ad hoc tasks.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• University / college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• 0 - 1 year in clinical research.
• Demonstrated ability to organize and communicate effectively.
• Demonstrated ability to pay attention to detail.
• Ability to work well with others.
• Ability to deliver consistent high quality of work. Ability to use computer and departmental tools.

Physical Demands/Work Environment:

• Office based
• May require overtime and weekend work as required.
• Should be willing to work in flexible shifts as per business requirement.

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