Medical Director - Psychiatrist (BB-209CF)
Found in: Neuvoo CA
Interactswith senior management, customers, and project teams to ensure the safety ofsubjects in clinical trials; ensures the scientific integrity of the clinicalportions of clinical trials; provides medical input to clinical programs;provides clinical development and regulatory consulting advice as needed. Performs the duties of a Medical Monitor.Essential Functions :
Managessubject safety and the scientific integrity of clinical trials.
Responsible for subject-safety and the scientificintegrity of clinical trials.
Participates in bids, bid-defenses & feasibilityassessments when requested.
Provides project-specific and therapeutic training tosponsors and Company staff as needed.
Works with the Drug Safety Department by providingmedical input and oversight.
Works with Medical Writing/Regulatory in thepreparation of a variety of documents as required.
Maintains in-depth knowledge of worldwide drugdevelopment regulations and Good Clinical Practice (GCP) guidelines.
Interacts with senior management, project management,and other departments as appropriate.
Provides clinical development and regulatoryconsulting advice both within Company and to clients as requested.
Locates and interacts with outside experts asnecessary.
Provides feedback to management on quality issues withinthe clinical trial team
Assumesline-management duties as needed.
Performs otherwork-related duties as assigned. Minimal travel may be required (up to25%).
Adoctoral-level degree in psychiatric medicine and must have practiced psychiatric medicine and haveclinical research experience in psychiatry. In-depthknowledge of FDA and worldwide drug-development regulations. Strong understanding of the use of medicalterminology and of drug-names in multiple nations, cultures andenvironments. In-depth knowledge ofnational and ICH Good Clinical Practice (GCP) guidelines. Basic computer and word-processing skills,including the use of spreadsheets, e-mails and smart-phones. Experience working in matrix-teams. Ability to handle multiple tasks to meetdeadlines in a dynamic environment. Effective organizational and interpersonal skills. Skilled at presenting data to groups, and inthe creation of effective documentary communication. Customer-focused with a disciplined approachto work with excellent verbal communication and language skills. Fluency in written and spoken English.
Primary Location:North America - US Home-Based
Other Locations:North America - CAN-Home-Based
Travel:Yes, 25 % of the Time
calendar_today14 hours ago
location_onQuebec City, Canada
work Syneos Health