Associate Data Manager - FS

Accountabilities:

• • Clinical data review: Review clinical trial data through clinical data management systems (CDMS) and external listings to verify that captured information follows protocol requirements and the Data Management Plan.
  • Data management planning: Provide input to and review Data Management Plans, helping ensure that study-specific data management activities support required clinical deliverables.
  • Query management: Identify problematic or inconsistent data and generate queries for appropriate stakeholders, including investigative sites, vendors, Clinical Research Associates, and client representatives.
  • Query resolution: Review responses for completeness and appropriateness, resolve discrepancies, and update clinical databases as required.
  • CRF and edit check support: Assist with the development of Case Report Forms (CRFs) and edit check specifications in accordance with study protocols.
  • User acceptance testing: Participate in UAT activities for CRFs, edit checks, and study-specific data listings, ensuring outputs meet defined requirements.
  • Testing documentation: Prepare and maintain documentation related to initial and follow-up testing, ensuring changes have been appropriately implemented and verified.
  • Quality and delivery: Take ownership of assigned tasks and deliver accurate, timely work that contributes to a positive experience for internal and external stakeholders.
  • Cross-functional collaboration: Work effectively with clinical, data management, vendor, site, and client teams to resolve issues and maintain study progress.
  • Project coordination: Manage multiple activities and priorities in a fast-paced clinical research environment while maintaining strong attention to detail and data quality.

  Requirements:

  • Education: Bachelor’s degree or international equivalent from an accredited institution, preferably in a technical, clinical, health-related, or similar field; an equivalent combination of education, training, and relevant experience may also be considered.
  • Clinical data management experience: 3–5 years of practical experience using commercial clinical data management systems and/or Electronic Data Capture (EDC) platforms such as Oracle RDC/Inform, Medidata Rave, DataLabs, or comparable systems.
  • Functional expertise: Proven experience performing the core responsibilities associated with clinical data management, including data review, query management, database updates, testing, and documentation.
  • Communication: Excellent written and verbal English communication skills, with the ability to interact effectively with diverse internal and external stakeholders.
  • Technical proficiency: Strong computer skills in a Microsoft Windows environment, including proficiency with Microsoft Office applications such as Outlook, Word, and Excel.
  • Analytical ability: Strong analytical and problem-solving skills, with a methodical approach to identifying discrepancies and ensuring data accuracy.
  • Organization: Excellent organizational and time-management skills, with the ability to work independently and manage several projects or priorities simultaneously.
  • Customer focus: Demonstrated ability to support positive customer experiences through effective communication, ownership of deliverables, and consistent, high-quality and timely execution.
  • Adaptability: Comfortable working in a fast-paced environment with changing priorities and able to remain effective while managing multiple deadlines.
  • Working schedule: Availability to work Monday through Friday, 11:00 AM–7:00 PM India time.
  • Contract: Willingness to work on a fixed-term contract through the end of October 2026.

  Benefits:

  • Fully remote position based in India.
  • Fixed Monday–Friday schedule, 11:00 AM–7:00 PM.
  • Opportunity to contribute to clinical research supporting the development of medicines, medical devices, and diagnostics.
  • Exposure to biotech, MedTech, and specialty pharmaceutical clinical development programs.
  • Access to innovative technologies used within clinical research and data management.
  • Opportunities for continuous learning and professional development.
  • Collaborative, diverse, and internationally oriented working environment.
  • Opportunity to work with multidisciplinary teams and contribute to meaningful clinical study deliverables.
  • A culture that encourages employees to contribute ideas, take ownership, collaborate, and grow professionally.