Clinical Research Manager
Siolta Therapeutics is seeking a highly motivated and talented clinical research manager to provide support for the company’s clinical development program focused on prevention and treatment of allergic diseases through manipulation of the gut microbiome. The successful candidate will work closely with other team members to further develop Siolta’s on-going clinical research program and will be responsible for clinical trial design, implementation, and monitoring.
4-year college degree
Minimum of 3-5 years of experience in on-site monitoring of clinical trials
Experience in all aspects of clinical trial monitoring (e.g., on-site/remote/etc.)
Strong project management skills to ensure timeliness of studies, within budget, and proactive identification of scope changes
Experience in multiple indications and study types
Strong written and verbal communication skills
Comprehensive knowledge of GCP/ICH guidelines
Exceptional attention to detail
Strong problem-solving skills
Graduate degree (MS or PhD)
Experience with pediatric populations
Experience with allergic diseases, such as allergy and asthma
Experience building a clinical operations team and in-house systems and SOPs
Establish relationships with clinicians and researchers at various sites and evaluate site feasibility in preparation for future clinical trials
Develop clinical study protocols in collaboration with the Siolta team and site staff
Serve as primary contact for research sites, verifying that the investigator, staff, and site facilities remain adequate throughout the trial period according to the monitoring plan
Perform source data verification against Case Report Form/Electronic Data. Capture entries in compliance with the Monitoring Plan and ensures accurate and complete data with appropriately documented changes by authorized site staff
Deliver high-quality written trip reports, confirmation and follow-up letters within timelines of SOPs and monitoring plans
WHO WE ARE:
Siolta Therapeutics is a clinical-stage biotech located in San Francisco and focused on developing microbial therapeutics to prevent and treat inflammatory disease, starting with asthma. We are developing a strong multi-disciplinary team to support our vision of a future with less chronic disease. Siolta Therapeutics offers competitive salary, equity plans, and full benefit packages that are commensurate with experience.
Please provide a cover letter, CV, and three references to email@example.com or apply online below.