Medical Scientist

This is a fully remote position, open to applicants in India.

📋 Description

• Act as a Clinical Data Reviewer, identifying discrepancies in data by conducting reviews according to the Data Review Plan (DRP) and managing the issuance and closure of queries.

• Continuously assess the clinical and medical aspects of study participant data and documentation, escalating issues as necessary.

• Generate clinical data queries, ensuring prompt follow-up, closure, or re-querying after receiving site responses.

• Communicate the data training requirements or concerns for Clinical Research Associates (CRAs) and sites to the Sponsor.

• Provide project management updates for clinical data review and establish expertise in clinical and medical data review and cleaning.

• Collaborate with Clinical Compliance and Systems Validation Compliance to ensure data quality and readiness for audits.

• Assist in the review and contribution to data capture requirements guidance in alignment with protocol and reporting standards.

• Monitor the performance of site data entry, supplying information to identify root causes and implement corrective measures.

• Ensure prompt follow-up and resolution of clinical data compliance issues.

• Evaluate opportunities to enhance task efficiency and improve data deliverables.

• Contribute to EDC completion training sessions.

• Occasionally attend clinical data review meetings and prepare presentation slides for those meetings.

• Create or review materials for data dissemination meetings and, if necessary, present at these meetings.

• Collaborate with Clinical Scientists, Study Medical Directors, Data Management, and Clinical Operations throughout the study process, especially before data cuts, interim analyses, DSURs, IBs, regulatory requests, site closures, and final database locks.

• Participate in the quality control review of patient narratives.

⛳️ Requirements

• Equivalent experience, skills, and/or education will also be taken into account.

• Proficient in clinical and medical data review and cleaning.

• Familiarity with clinical study participant data and documentation, including eligibility criteria, diagnoses, medical histories, prior treatments, drug administration, adverse events, concomitant medications, safety laboratories, efficacy assessments, and study endpoints.

• Ability to issue, follow up on, close, and re-query clinical data queries effectively.

• Capability to evaluate data quality and provide support for audit readiness.

• Competence in monitoring site data entry performance and identifying underlying causes of data issues.

• Proficiency in collaborating with Clinical Scientists, Study Medical Directors, Data Management, and Clinical Operations.

• Ability to contribute to EDC completion training and conduct quality control reviews of patient narratives.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in both technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive workplace culture.

• Access to extensive resources, including emerging technologies, data, science, and knowledge sharing.

• Reasonable accommodations, when appropriate, to help employees or applicants perform essential job functions.