Dermatology Medical Monitor (part-time contract)
Vial
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See open jobs at Vial.See open jobs similar to "Dermatology Medical Monitor (part-time contract)" General Catalyst.United States
Posted on Saturday, May 20, 2023
Who We Are
Vial is a next-generation, tech-first CRO delivering faster, more efficient clinical trials at dramatically lower costs for biotech sponsors. Our mission is to empower scientists to discover groundbreaking scientific therapeutics that help people live happier, healthier lives.
We are more than just a CRO — we are "doers". We are reimagining clinical trials and have assembled a talented team of executives from Silicon Valley and industry-leading CROs. Together, we have built a global, full-service CRO powered by intuitive end-to-end technology.
Vial operates across multiple Therapeutic Areas (Dermatology CRO, Ophthalmology CRO, Oncology CRO, Gastroenterology CRO, Neurology CRO, Cardiology CRO, Medical Device CRO, Rare Disease CRO, and Digital Therapeutics CRO).
Vial is a San Francisco, California-based company founded by Simon Burns and Andrew Brackin in October 2020. Since our founding, we have become a fast-growing company of 100+ employees with over $100 million in funding.
Vial is building towards a more efficient future for clinical trials. By deploying technology in every step of a trial, we are driving efficiencies in speed and cost that we pass on to innovative biotech startups. Ready to join us on our journey to reimagine clinical trials?
Overview
We’re looking to hire a Dermatology Medical Monitor, who will be responsible for providing input into the design and conduct of clinical trials, reviewing and/or generating key study documents (such as medical monitoring and safety management plans, treatment manuals, etc), assessing and interpreting safety data, and contributing to investigator, other site staff and clinical study team training. The Medical Monitor is the main point of contact for Investigators for medical and protocol related questions. They will provide medical knowledge and expertise to the day-to-day operations of clinical research studies by answering medical questions coming from the study team. You’ll report to our EVP of Clinical Strategy.
Key Responsibilities
- Work as primary Medical Monitor for assigned clinical trials which includes being readily available to advise on trial related medical questions or problems during the conduct of the trial.
- Review and analysis of eligibility per inclusion/exclusion requirements of a clinical trial.
- Reviewing all adverse events to look for trends or risks, review all serious adverse events (SAEs), including review of the narrative, investigators’ assessment on causality, and applicable regulatory reporting.
- Provide review of study protocols and ongoing medical oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
- Consult with internal and external stakeholders and experts to assist in the development and assisting in the design and conduct of clinical trials including the drafting of protocols and amendments.
- Assist with business development activities, including participation in bid defenses, and the development of business proposals as it pertains to Medical Affairs.
- Develop and/or review operational, medical monitoring, and safety plans for awarded studies.
- Assist in the study feasibility process by generating/reviewing feasibility questionnaires, identifying patient pathways, defining standard of care, and support site identification and selection.
- Lead and/or participate in scientific and medical training to other Vial team members and outside clients, investigators, and other site staff as it pertains to assigned studies.
- This may include travel, attendance, and presentation at investigator meetings, symposiums, and/or conferences.
- Monitor patient safety by acting as a medical monitor and/or in the development and conduct of a DSMB.
- Ensure activities related to SAEs are conducted in accordance with applicable SOP’s and regulations.
- Generate safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete.
- Write and/or review Safety Narratives, Investigator Letters, and other safety documentation for site reported safety events.
- 24/7 emergency coverage for safety related matters.
What You'll Bring
- Board certified Dermatologist
- Minimum of 5 years experience in medical monitoring and/or pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment required.
- Proficient with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
#LI-Remote
Why You’ll Love Working At Vial
Innate curiosity. At our core, we embody an insatiable curiosity. Our journey into the realm of clinical trials was ignited by a firsthand understanding of the challenges involved. This innate curiosity drives us to constantly innovate, seek fresh ideas, and bring our vision of reimagining clinical trials to life.
Fostering autonomy. Autonomy is our guiding principle. We firmly believe that when team members are entrusted with autonomy, they unleash their true potential. Our culture fosters an environment where each individual takes ownership of their domain, empowering them to make a profound impact.
The pursuit of mastery. We are dedicated to cultivating mastery. We understand the value of honing expertise in a craft. The pursuit of mastery, coupled with a deep sense of pride in one's workmanship, fuels our unwavering commitment to tackle intricate challenges. At Vial, we foster a culture of highly autonomous professionals, each an expert in their field, collaborating on an immensely demanding endeavor together.
Move fast, stay humble. Our strength lies in agility and humility. We firmly believe that intellectual honesty and a nimble mindset are the pillars of success. By staying adaptable and open-minded to all solutions, we tackle obstacles head-on, remaining humble in the face of adversity. This enables us to surmount the hurdles that confront us at every twist and turn.
Benefits
Competitive Equity Compensation
Health, Dental, and Vision
Remote-First
Paid Parental Leave
Unlimited Vacation
This job is no longer accepting applications
See open jobs at Vial.See open jobs similar to "Dermatology Medical Monitor (part-time contract)" General Catalyst.