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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