job title: Clinical trial registration specialist(Bristol myers squibb)

Roles and Responsibilities

Job Title
Clinical Trial Registration Sr. Specialist
Division
Research & Development
Functional Area Description
Global Development Operations / Trial Delivery Support (TDS) / Trial Risk and Integrity Management (TRIM)/ CT Transparency & Submission
Position Summary / Objective
The Clinical Trial Registration Sr. Specialist will report to the Clinical Trial Registration Lead, prepare and provide operational support for the registration and maintenance of clinical trials into public registries in US, EU and other countries as required.
Position Responsibilities
Drives the processes for assigned protocol registration activities, resulting in timely, high-quality information posted on clinical trial registries (Clinicaltrials.gov and EU PAS).

Liaises with clinical team reviewers (Global Trial Managers, Operations Leads, Statisticians, Clinical Trial Physicians, Clinical Scientists, Development Leads, Patent Attorneys) and other stakeholders on all assigned trials to ensure trial registrations are accurate, consistent with the protocol and other source data, and reported in adherence to NIH guidelines.

Provides maintenance support to CT Registration Lead for assigned records, to ensure the consistent accuracy of information disclosed on Clinicaltrials.gov.

Submits registration updates to Clinicaltrials.gov on behalf of clinical team, within global regulatory timelines.

Maintains study trackers and ensures they are up to date every week.

Educates stakeholders, as needed, on NIH detailed review criteria for registrations as well as on the purpose and format of the different fields in the protocol registration form.

Support registration of clinical trials in public registries beyond US/EU as needed.
Degree Requirements
Bachelor’s degree, preferably in a Science-related field
Experience Requirements
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

Work experience in clinical trial transparency or clinical trial execution work, or work experience related to quality and compliance in clinical research preferred
Key Competency Requirements
Demonstrated Excel and analytical skills

Ability to work in a multi-functional team and across multiple therapeutic areas

Demonstrated ability to work independently and seek out support when needed  

Written and oral communication skills  

Strong organizational skills with the ability to multitask and prioritize, and take on new initiatives and improvement efforts.