Senior Study Startup Specialist
Not Disclosed•Full-TimeHybrid
location_on26, Hornor Lane, Queenston Common, Princeton, Mercer County, New Jersey, 08540, United States
About SystImmune
SystImmune is a leading, well-funded clinical-stage biopharmaceutical company with locations in Redmond, WA, and Princeton, NJ. We specialize in developing innovative cancer treatments using established drug development platforms, focusing on bi-specific and multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our pipeline includes multiple assets in various stages of clinical trials for solid tumor and hematologic indications, alongside a robust preclinical portfolio in the discovery and IND-enabling stages.
We are dedicated to cutting-edge biologics development and offer a dynamic environment where you can learn, grow, and make significant contributions to the company's success.
Work location
Work model: Hybrid
26, Hornor Lane, Queenston Common, Princeton, Mercer County, New Jersey, 08540, United States
Princeton, New Jersey
Key Responsibilities
- check_circleLead and oversee study start-up activities for complex, multi-site, and global clinical trials
- check_circleServe as subject matter expert for study start-up across cross-functional teams
- check_circleDevelop and execute site activation strategies to optimize timelines and reduce cycle times
- check_circlePrepare, review, and submit complex regulatory documents to IRBs, ethics committees, and authorities
Similar Job Opportunities
Skills, education and keywords
Skills: Ich-GCP, Fda, Ema, GDPR, CTMS, Etmf, Oncology, Biologics, Bi-Specifics, Adc.
Education: Bachelor's degree in Life Sciences, Nursing, Business, or related field required.
Frequently asked questions about Senior Study Startup Specialist at SystImmune
What does a Senior Study Startup Specialist at SystImmune do?expand_more
A Senior Study Startup Specialist at SystImmune is responsible for the following: Lead and oversee study start-up activities for complex, multi-site, and global clinical trials; Serve as subject matter expert for study start-up across cross-functional teams; Develop and execute site activation strategies to optimize timelines and reduce cycle times; and Prepare, review, and submit complex regulatory documents to IRBs, ethics committees, and authorities.
What are the requirements for this Senior Study Startup Specialist role?expand_more
To qualify for the Senior Study Startup Specialist at SystImmune position, applicants should have: Bachelor's degree in Life Sciences, Nursing, Business, or related field; Minimum 5-8 years of progressive experience in clinical study start-up, site activation, or regulatory submissions; Oncology clinical trial experience required; Deep working knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements; Advanced proficiency with CTMS, eTMF, and clinical trial platforms; and Strong contract and budget negotiation experience.