Job Description

Drug Development, Medical Monitor - Consultant, Rheumatologist MD

We’re looking for an experienced Rheumatologist MD contractor to support our team from a medical monitoring perspective during Phase 1 clinical trials. This role will be instrumental in overseeing patient safety, providing medical expertise, and ensuring clinical trial protocols are adhered to and aligned with the highest scientific and ethical standards. This consultant will work closely with the clinical development team to support the execution and monitoring of early-stage trials.

Responsibilities:

• Serve as medical monitor for rheumatology-related studies, provide expert medical oversight for Phase 1 clinical trials, and ensure the safety and well-being of trial participants.
• With support from the VP of Clinical Development, help lead the execution of multiple global phase I studies.
• Review and assess safety data, adverse events (AEs), and serious adverse events (SAEs) to ensure proper reporting and management by regulatory guidelines.
• Assist in interpreting trial data and ensure that findings align with the study's objectives and are reported accurately to stakeholders.
• Offer medical expertise to the internal clinical team, participate in study team meetings with CRO, and interact with sites/site-facing vendors.
• Partner with the clinical and regulatory teams to ensure compliance with all regulatory standards and provide insights from a rheumatologic perspective.
• Act as a medical point of contact for internal teams, external partners, and regulatory authorities throughout the trial process.

Qualifications:

• MD with specialization in Rheumatology.
• Minimum of 5 years of clinical experience in rheumatology.
• Experience in clinical trial monitoring for Phase 1 trials.
• Strong understanding of GCP, ICH guidelines, and FDA/EMA regulations.
• Excellent communication skills and the ability to collaborate effectively with cross-functional teams.
• Proven ability to assess and manage patient safety during clinical trials.
• Flexible availability to support the needs of the trial, including regular meetings and real-time issue resolution.

*Remote or Bay Area Hybrid
*25-30 hours per week

Job Tags

Remote job, Contract work, For contractors, Flexible hours,

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