Syneos Health

Medical Director - Psychiatrist (BB-209CF)

Found in: Neuvoo CA

Description:

Description

Summary:

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.

  • Performs the duties of a Medical Monitor.
  • Provides 24-hour coverage for 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

  • Represents Company at scientific meetings as required.
  • Primary senior-level contact for customers.
  • Assumesline-management duties as needed.

  • OtherResponsibilities:

    Performs otherwork-related duties as assigned. Minimal travel may be required (up to25%).


    Qualifications

    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

    Job

    :Medical Affairs

    Schedule

    :Full-time

    Travel

    :Yes, 25 % of the Time

    Employee Status

    :Regular

    calendar_today14 hours ago

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