GCO Submission Lead
- Represents GCO on cross functional submission teams and is the key GCO point of contact for other functional leaders
- Drives the development and finalization of GCO operational submission deliverables for Integrated Oncology with planned expansion to Integrated Medicines. Submission deliverables include the following:
- Financial Disclosure Tables and FD Package
- BMS Employment check
- Office of Scientific Information (OSI) Site Level Listing Data Sheet
- Office of Scientific Information (OSI) Reviewer's Guide
- CRF PID List and CRF Word list
- Manage process for literature search updates
- Coordinates requirements for output with Stats (GBS) and Dossier Lead/Submission Managers and NACC (for Clinical Trial Support Specialist assigned to work streams)
- Tracks metrics, timelines, and other data for GCO deliverables partnering with the Operations Lead and study teams
- Focuses on standardizing and streamlining processes and documents
- Leads the Protocol Model Document Management Team
- Leads and manages the BMS Protocol Model Document template & updates and represents BMS on TransCelerate Common Protocol Template Initiative
- Candidate must have a minimum of a BA or BS Degree with approximately 8-10 yrs. of experience in clinical drug development.
- Strong leadership competencies and influencing skills with senior leaders and cross functional leaders.
- Effective oral and written communication skills to influence, inform and guide a large scale global operational team.
- Broad knowledge of submission deliverables and strong project management skills.
- Proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams.