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Drug Development, Medical Monitor - Consultant

Mountain View, CA 94043

Posted: 09/26/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 614962 Is job remote?: Yes Country: United States

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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Mountain View, CA

Explore exciting job opportunities in the vibrant area around Mountain View, California! Known for being the heart of Silicon Valley, this region offers unparalleled growth prospects and an innovative tech-driven environment that is perfect for career advancement. With landmarks like the iconic Googleplex and the Computer History Museum, and nearby attractions such as Shoreline Amphitheatre and NASA Ames Research Center, there's no shortage of inspiration in this dynamic area. Enjoy the diverse cuisine, thriving art scene showcased at the Mountain View Center for the Performing Arts, and the beauty of nearby parks like Shoreline Park and Stevens Creek Trail. Join us in discovering the endless possibilities for professional and personal growth in Mountain View!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.