Responsible for directing all operational aspects of the clinical study programs. This role is accountable for providing leadership and management oversight to ensure clinical trials are conducted on time in support of company program goals and in accordance to all applicable regulatory standards in support of regulatory submissions. Requires leadership, strong experience in clinical operations, critical thinking and ability to build strong internal and external alliances.
Oversight of all clinical operations components related to clinical study programs both internal and external
Provides strategic leadership and experience on all clinical operations aspects
Leads, develops and manages Clinical Operations Manager(s)
Management and development of company standard operating procedures (SOPs) as required
Leads the Clinical Research Organization (CRO) request for proposal (RFP) process; including presenting top choices to management and providing selection recommendation
Builds an approved vendor CRO list that allows for multi choice CRO selection based on study needs
Manages vendor contracts and all budgetary components associated with clinical study programs
Liaisons with CRO counterpart(s) in management of the operational aspects of studies, e.g., study start up, site contracting/activation, medical monitoring, safety, data management, etc.
Provides direction and strategy related to site selection and patient recruitment efforts and activities to deliver on enrollment targets
Attends site visits, conferences, etc. as necessary to build/maintain key relationships with PIs and study staff
Works collaboratively with cross functional internal teams to ensure clinical operation activities are linked appropriately to the overall program deliverables
Provides regular updates to management team and provides solutions as needed to program risks and barriers
BS/BA degree required in science/heath related field; Master's degree preferred
10+ years of clinical operations management experience
Excellent working knowledge of ICH GCP guidelines, CFR, and HIPPA regulations
Strong leadership and vendor management skills
Ability to manage multiple priorities, while maintaining attention to critical details
Excellent written and oral communication and presentation skills
The above statements are intended to describe the general nature and level of the work being performed by employees assigned to this position. This is not intended as an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
As part of Aquestive's employment process, final candidate will be required to complete a drug test and background check prior to employment commencing.
Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Aquestive Therapeutics, Inc.