Description
Responsibilities:* Development and/or writing study documents (protocols, protocol amendments, CRFs, investigational brochures, annual report, study guidelines, etc.)
* Qualifying, monitoring and managing sites including co-monitoring with the CRO
* Management of various CROs and vendors involved in the study (e.g. monitoring, data management, central labs, etc)
* Implementation of operational activities and project management tasks associated with clinical studies (eg. central lab coordination, SAE tracking/reconciliation, etc.) to ensure they are conducted in a successful, timely manner and within budget
* Responsible for all start-up activities including but not limited to: site selection, drug preparation, enrollment, data collection, etc.
* Proactively identifying solutions when issues arise
* Organization of investigator, steering committee, and data monitoring committee meetings
* Assist with CRO and vendor identification and selection process
* Management of key study parameters (e.g. start-up activities, drug preparation, enrollment, data collection, etc)
* Implementation and management of operational plans
* Data review (patient profiles, line listings, patient narratives, etc.)
* Preparation of study updates
* May take on timelines and budget management, as applicable
Skills:
* 4 years in the pharmaceutical industry including in-house experience
* Solid, hands-on clinical trial experience including site monitoring
* Strong organizational and oral and written communication skills
* Solid experience developing/writing study documents (protocols, annual reports, etc.)
* Ability to work as a team player and the ability to work in a fast-paced environment
* Must be flexible, detail-oriented and have an interest in professional growth
* Energetic, self-starter, able to multi-task and be proactive
* Some travel required