Data Review Specialist

3 days ago


Thiruvananthapuram, Kerala, India Lifelancer Full time

**About the Job**

Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT, is seeking an experienced Data Review Specialist to join our team. In this role, you will be responsible for performing medical data reviews, ensuring applicable SOPs/Guidelines, Sponsor/Client directives, and GCP guidelines are followed.

**Key Responsibilities**

  • Perform designated review of safety and efficacy data using visual analytics programs (e.g., Spotfire, J-Review, Tableau, Qlik Sense, Power BI).
  • Review and input into the design of eCRF fields relevant to Medical data review for projects.
  • Develop, input, and/or review project-specific Medical Data Review Plans (MDRPs) or equivalent documents.
  • Implement Medical data review tools, including listings, patient profiles, and visual analytic templates.
  • Review and/or input into the review of various types of Medical data, such as vital signs, physical examination results, laboratory tests, ECG results, imaging results, adverse events, concomitant medications, past medical history, protocol deviations requiring Medical review, efficacy assessments, and other types of Medical data specified per project.
  • Generate, review, and/or input into the review/closure of Medical queries.

**Requirements**

  • At least 1 year of clinical experience post-degree and at least 2 years of experience in the Pharmaceutical, Biotech, Medical Device and/or CRO industry working with clinical data.
  • Highly desirable: Experience of working in a Medical or drug development environment performing medical data review using visual analytics programs; experience implementing Medical data review templates for complex data sets; experience in oncology studies.

**Skills and Qualifications**

  • Clinical thinking: ability to use data review tools, perform designated review of safety and efficacy data, formulate good queries; ability to understand data collection in project specific documents to optimize oversight of patient safety, data integrity, and successful completion of project.
  • Deep understanding of the scientific basis for therapies and pathology induced by disease states.
  • Strong knowledge of the drug/device/vaccine development process.
  • Understanding of ICH GCP, applicable regulatory requirements for study data, good documentation practices.
  • Time management: good sense of urgency, prioritization skills.
  • Team player: effective participant as a team member and team leader.
  • Attention to detail.
  • Creative problem-solving skills.
  • Effective oral and written communication and presentation skills (at least in English).

**What We Offer**

  • A competitive salary of $65,000 - $80,000 per annum, depending on experience.
  • An opportunity to work remotely up to 90% of the time.
  • The chance to work with a dynamic and growing company in the Life Sciences industry.
  • Ongoing training and professional development opportunities.


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