Senior Specialist Clinical Trial Registration Expert
4 weeks ago
Bristol Myers Squibb is a leading pharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Senior Specialist Clinical Trial Registration to join our team.
Job SummaryThe Senior Specialist Clinical Trial Registration will be responsible for preparing and providing operational support for the registration and maintenance of clinical trials into public registries in the US and EU. This includes driving the processes for assigned protocol registration activities, liaising with clinical team reviewers, and providing maintenance support to ensure the consistent accuracy of information disclosed on Clinicaltrials.gov.
Key Responsibilities- Drive the processes for assigned protocol registration activities, resulting in timely, high-quality information posted on clinical trial registries.
- Liaise with clinical team reviewers and other stakeholders to ensure trial registrations are accurate, consistent with the protocol, and reported in adherence to NIH guidelines.
- Provide maintenance support to ensure the consistent accuracy of information disclosed on Clinicaltrials.gov.
- Submit registration updates to Clinicaltrials.gov on behalf of the clinical team, within global regulatory timelines.
- Maintain study trackers and ensure they are up to date every week.
- Educate stakeholders on NIH detailed review criteria for registrations and the purpose and format of the different fields in the protocol registration form.
- Bachelor's degree in a Science-related field.
- Minimum of 3 years overall work experience, preferably in a biopharmaceutical or CRO company.
- Work experience in quality, regulatory, compliance, clinical research, or drug development highly desirable.
- Strong Excel and analytical skills, ability to work in a multi-functional team, and written and oral communication skills.
Bristol Myers Squibb offers a unique and inclusive work environment that promotes diversity and innovation. Our employees are empowered to apply their individual talents and unique perspectives to make a meaningful impact on patients' lives. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
Equal Employment OpportunityBristol Myers Squibb is an equal employment opportunity employer and welcomes applications from diverse candidates. We are committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support in their roles.
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