This is an exciting opportunity to join an enthusiastic and collaborative Clinical Development Operations (CDO) team by contributing to the overall success of our novel gene therapy approach in cerebral adrenoleukodystrophy (CALD). Reporting to a Director of Clinical Development Operations, the successful candidate will be responsible for supporting multiple CALD studies. This position is a key team member who will effectively organize and assist in the start-up, implementation, management and close-out of our CALD clinical trials, working closely with internal and external team members around the world.
- Provide overall program support to the CDO CALD team as well as liaise with other internal and external collaborators to execute on the pharmaceutical company's clinical studies
- Assist with the oversight of vendors including CROs, study vendors and independent contractors; actively participates in revisions to study documents
- Responsible for oversight and maintenance of Central Files (eTMF), including ensuring files are inspection-ready
- Assist with review of study specific data in preparation for database lock
- Plans and organizes study related meetings; takes detailed notes at meetings on decisions and action items and distributes the list to the team in the form of minutes
- Knows the stage of study activities and communicates details to ensure that all team members are kept informed and aware of action items that will impact their tasks. Ensure all study metric trackers, contact lists, checklists and systems are up to date.
- Communicates with CROs and/or CRAs to support accurate completion, retrieval and review of documents in support of regulatory filings
- Assists in the development of timelines; tracks of details to ensure information is current and timelines are met.
- Must have ability to be on-site 100% of the time
- Bachelor's Degree in science or health-related discipline, advanced degree preferred
- Minimum 3 years relevant industry or CRO experience, with site monitoring
- Deep understanding of and experience with electronic TMF, regulatory agency inspection experience preferred
- Proficiency in the entire Windows Suite, including MS-Project
- Solid knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations is required. A broad understanding of essential study documentation is critical.
- Ability to foster relationships with vendors, clinical sites and colleagues
- The ability to support several projects simultaneously, a flexible working style and attention to detail are essential. Comfortable working independently.
- Independently motivated, detail oriented and good problem solving ability.
- Strong organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
- Clear and transparent communication skills.
- Positive, outgoing and collaborative attitude
If you or a Clinical Research Associate you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role.
Sthree US is acting as an Employment Agency in relation to this vacancy.