Must meet all requirements for CTMA position and have demonstrated proficiency in all relevant areas
Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams
Must be able to anticipate obstacles and proactively develop solutions to achieve project goals
Must have a general understanding of functional issues and routine project goals from an organizational perspective
May participate in abstract presentations, oral presentations and manuscript development.
Interfaces with individuals in other functional areas to address routine study issues
Ability to develop tools and processes that increase measured efficiencies of the project
May be asked to assist in the training of CTMAs and CPAs
Assists in CRO or vendor selection
Coordinates CROs or vendors
Assists in the setting and updating of study timelines
Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
May conduct site evaluation, initiation, co-monitoring, and closeout visits in addition to routine monitoring visits, as required
Assures site compliance with the protocol and regulatory requirements
Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans
Excellent verbal, written, interpersonal and presentation skills are required
Knowledge of FDA and or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
Working knowledge and experience with Word, PowerPoint and Excel

Clinical Trials Management Associate – II

About the role