Senior Clinical Project Manager

New
C
ClinChoiceClinical Research CRO
Remote-USFull-TimeSenior
Salary not disclosed
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Job Details

Languages
English
Experience
Eight (8) years (at least) of clinical research experience in Project Management.
Required Skills
Budget management

Requirements

  • Bachelor's Degree in scientific, medical, or paramedical disciplines.
  • At least 8 years of clinical research experience in Project Management.
  • Proven experience managing oncology and respiratory studies.
  • Prior CRO experience is required.
  • CRA experience is highly desirable.
  • Excellent knowledge of clinical trial operations, GCP/ICH Guidelines, and regulatory requirements.
  • Proficiency in Microsoft Office (Word, Excel, Outlook).
  • Fluent in English.
  • Experience with electronic data capture preferred.

Responsibilities

  • Manage and coordinate the assigned clinical projects.
  • Manage all project specific services required by the Sponsor.
  • Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators.
  • Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, etc.).
  • Assure the proper timelines of the assigned projects and manage the budget.
  • Monitor the workload and performance of the project team.
  • Coordinate the Clinical Research Associates and Clinical Monitors activity.
  • Collaborate with the Biometrics team and other project members (Safety, Regulatory, etc.).
  • Assist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study Reports.
  • Perform co-monitoring visits as necessary and provide project updates to the Sponsor and leadership.
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