Medical Monitor

Nextvel Consulting LLP; Bengaluru; On-site; INR 800,000 - 1,400,000; Full time

Job summary

Nextvel Consulting LLP is seeking a Medical Monitor to oversee patient safety during clinical trials, analyze adverse events, and provide medical guidance to the study team. The role involves protocol review, safety data interpretation, and collaboration with investigators and regulatory bodies to ensure compliance with GCP guidelines.

Travel may be required. The candidate should have 2–5 years of experience, strong analytical and communication skills, and a solid background in regulatory

Qualifications

• Trained in current Good Clinical Practices (GCP) and local/global regulatory requirements for clinical research.
• Self-motivated, research oriented, highly organized with strong analytical and critical thinking.
• Excellent communication, presentation and negotiation skills.
• Strong proficiency in Microsoft Office, especially Excel.
• Ability to lead independently and manage multiple tasks.

Responsibilities

• Safety oversight of patient safety and adverse events with follow-up.
• Review and develop safety-related protocol elements and guidelines.
• Interact with investigators and regulatory bodies to communicate findings.
• Review SAE/SUSAR data and provide medical input to the team.
• Ensure trial conduct complies with GCP and regulatory requirements.
• Collaborate with Clinical Operations for safety assessments.

Skills

Regulatory knowledge

Analytical thinking

Communication skills

Presentation skills

Time management

Team player

Proactive initiative

Tools

Microsoft Office

Excel

Job description

The Medical Monitor will perform the following duties:

Project related duties include:

• Patient Safety Oversight which involves:
• Regularly analyzes adverse events, identifies serious adverse events, and ensures proper follow-up until recovery.
• Communicates findings to stakeholders (investigators, regulatory bodies) to ensure patient safety.
• Provides medical advice and guidance to the study team and investigators regarding patient safety concerns.
• Protocol Review and Development:
• Reviews and evaluates information relevant to product safety throughout the development and implementation of the protocol.
• Provides input on protocol design, including study halting rules, and safety guidelines.
• May suggest protocol modifications to prevent or manage adverse events.
• Medical Data Review and Interpretation:
• Reviews patient data from a safety perspective.
• Participates in data review and interpretation, contributing to the overall understanding of the study results.
• Communication and Collaboration:
• Serves as a medical consultant to the project team, providing medical and therapeutic area expertise.
• Interacts with site investigators to provide them with information on the study product and address medical questions.
• Attends and participates in investigator meetings.
• Regulatory Compliance:
• Ensures that the trial is conducted in accordance with Good Clinical Practice (GCP) guidelines and regulatory requirements.
• Provides input on regulatory documents and submissions.
• Other responsibilities:
• Review SAE and potential SUSAR.
• Medical training and medical support
• Patient eligibility review
• Work closely with the Clinical Operations team for the assessment of Serious Adverse Events.
• Liaison with the Sponsor Medical Expert
• Writing SOPs for Medical Monitoring, Safety Management Medical Review etc.
• Any other tasks that are assigned from time to time.
• Willing to travel for job related tasks as identified from time to time.

Non-Project Related duties

• Prepare SOPs
• Prepare training materials.
• Interface with clients, sites and investigators when required.

Participate in business meetings and make presentations when required.

• Accomplish jobs assigned from time to time to meet satisfaction of the management.
• Work in alignment with the company objectives and common goal of the company.

Skills and Experience:

• 2 to 5 Years Experience
• Trained in current Good Clinical Practices guidance and local and global regulatory requirements for clinical research.
• Self-motivated, research oriented, highly organized, strong analytical and critical thinking skills and ability to independently lead.
• Good communication, Presentation and Negotiation skills.
• Excellent computer skills, proficiency in Microsoft office tools and especially excel spread sheet is an absolute must.
• Solid Verbal and written communication skills are necessary to interact smoothly with healthcare professionals and scientific community.
• Multi-tasking and excellent time management skills
• Exhibit routine and complex analytical skills.
• A focus on quality and accuracy
• Take initiative and work with integrity.
• Ability to establish and maintain effective working relationships.
• Team Player