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Senior Data Manager

3 months ago

india Inductive Quotient Analytics Full time

Hi All,


We are hiring for Data manager/Senior Data Manager/Lead Data Manager


Experience: 3 to 8 years

Location: Hyderabad


Job Description:

Key Responsibilities :


  • Experience in electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol and programming edit checks.
  • Develop, review, and maintain project-specific all DM documents including SOPs, data management plan (DMP), eCRF specifications, data validation plan (DVP), external data transfer agreements, CCGs, Help Text, etc.
  • Develop test cases for User Acceptance Testing (UAT) of Electronic Data Capture (EDC) systems.
  • Develop and Execute data cleaning strategies to subject data cleanliness perform data validation, discrepancy management, and query resolution.
  • Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data
  • Perform holistic data review and trending analysis and proactively identify issue, risks and develop mitigation strategies
  • Support and conduct Quality Review checks during study to ensure consistency, accuracy, integrity, and completeness
  • Establish and enforce data quality standards and procedures.
  • Experience in manage and implement mid-study changes, including protocol amendments, database modifications, and data collection updates.
  • Experience in the closeout activities, including but not limited to
  • Resolve all open data queries and discrepancies and perform thorough data reviews to ensure completeness and accuracy.
  • Finalize data cleaning activities and resolve outstanding issues and Obtain approvals from all stakeholders before locking the database.
  • Review and ensure the quality control of all deliverables, covering eCRFs, study documents, program/report specifications, outputs
  • Document lessons learned and best practices for future studies
  • Prepare necessary documents for regulatory submissions, including final reports and patient listings.
  • Ensure the accurate and timely filing of all data management documents in the Trial Master File (TMF).
  • Archive physical and electronic documents according to regulatory requirements.
  • Ensure all data management activities comply with Good Clinical Practice (GCP), Good Clinical Data Management Practices (GCDMP), and applicable regulatory guidelines (e.g., FDA, EMA).
  • Up to date on regulations regarding clinical data collection and clinical data standards such as: ICH E6 GCP (Good Clinical Practice Version 2), Artificial Intelligence (AI), GCDMP (Good Clinical Data Management Practices), data privacy, and new regulations like GDPR (General Data Protection Regulation) and ICH E8 on General considerations for clinical studies covering Quality by Design (QbD)


Qualifications

  • Bachelor’s or master’s degree in Life Sciences, or a related field (advanced degree preferred).
  • Minimum of 3 years of experience in clinical data management, with significant experience in leading data management teams.
  • Possess experience in therapeutic areas e.g. Oncology, Ophthalmology, etc. to provide specialized knowledge and support for clinical trials.
  • Proficiency with EDC systems (e.g., Medidata Rave, Veeva, Trial Master) and data management tools.
  • Maintain up-to-date knowledge of industry standards and regulatory requirements.
  • Ability to work effectively in a team and manage multiple projects simultaneously.
  • Excellent organizational, and communication skills.

Technical Skills:

  • Knowledge of SQL, SAS, or other data analysis tools.
  • Experience with database design and management.

Soft Skills:

  • Problem-solving and analytical skills.
  • Strong interpersonal and communication skills.
  • Ability to handle complex and confidential information.