Join Lifelancer as a Medical Data Review Specialist

 

Join Lifelancer as a Medical Data Review Specialist in Bengaluru, Karnataka

Position Name: Medical Data Review Specialist

Organization: Lifelancer

Qualification: Medical Doctors (MBBS)

Experience: 1-3 years of experience in medical practice/equivalent clinical research roles

Salary: Not disclosed

Location: Bengaluru, Karnataka (On-site, Full-time, Associate)

At Lifelancer, we are committed to delivering high-quality clinical development and patient access solutions. Our team works closely with clients to ensure compliance and accuracy in medical data review. Join us and be a part of a dynamic team that makes a difference in the healthcare industry.

Job Description

THE POSITION:

This position involves various responsibilities in central medical review, including data review, safety signal evaluation, and collaboration with study teams.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Perform ongoing Central Medical Review for multiple studies under guidance of a Medical Review Plan or any applicable documents and communicate findings at patient level with the team.
• Support team to ensure Critical Data Process Definition is completed with Data Management and input from project team and supports implementation of critical data focused EDC design.
• Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems.
• Ensure that tracking and status reporting are performed in a timely and accurate manner. Apply data to recommend any patient safety concerns.
• Contribute to the Risk Assessment and Categorization Tool for topics related to medical review and consider risks when planning tools configuration.
• Support the Data Expert with Critical Data and Process Definition and EDC design implementation.
• Support the development of medical review requirements, including design of the visualizations, taking into consideration the data feeds for the study (EDC, laboratory, etc.).
• Draft the Central Medical Review Configuration Plan. Maintain this Plan throughout the study including re-versioning as required.
• Draft Central Monitoring /Central Medical Review Plans in collaboration with the study team and update these on an ongoing basis including the refinement of visualizations and any change in data.
• Perform ongoing Central Medical Review, discuss findings with the study team.
• Collaborate with other Central Monitoring activities to ensure consistency and effectiveness.
• Act as subject matter expert based on education qualification/experience.
• Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders.
• Prepare and distribute the quality reports at intervals during study conduct and at study close out.
• Ensure filing of study documents in the central files in a central office or hub location.
• Take responsibility for inspection readiness for medical assessment activities; support regulatory authority inspections when needed.
• Track Request for Proposal opportunities and Project/Studies and their status accurately. Propose process improvements and solutions to current process issues.
• Support the implementation of ideas into systems and tools improvements.
• Provide training on the project and process to new team members. Mentor new team members.
• Any other duties assigned by supervisor.

QUALIFICATIONS (MINIMUM REQUIRED):

• Medical Doctors (MBBS)

LANGUAGE SKILLS:

• Speaking: English required
• Writing / Reading: English required

EXPERIENCE (MINIMUM REQUIRED):

• Medical doctors (MBBS) with 1-3 years of experience in medical practice/equivalent clinical research roles

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains. Learn more at https://lifelancer.com

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