Clinchoice Inc.
Senior Clinical Project Manager
Remote-US · Senior
Sponsorship not specifiedDetected 1 day ago
GCPComputer VisionProject ManagementExcelClinical TrialsClinical ResearchMedical DevicesResearchCollaborationMicrosoft Office
About the role
- ClinChoice is a global full-service CRO recognized for its commitment to professional development, strong work-life balance, and a collaborative, quality-driven "one-team" culture.
- Qualified candidates will have 8+ years of clinical trial management experience, including prior experience within a CRO environment.
- This is a permanent remote opportunity, with the potential for a hybrid work arrangement depending on location.
Responsibilities
- Manage and coordinate the assigned clinical projects.
- Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members.
- Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.).
- Manage the budget for the project.
- Collaborate with the Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activities.
- Collaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.).
- Collaborate with the CTAs in archiving activities.
- Deliver project specific trainings.
- Perform co-monitoring visits for the assigned clinical projects as necessary.
- Maintain relationships with the Sponsor, including providing project updates.
Requirements
- Manage all project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.).
- Provide project updates to the Sponsor, Senior Project Manager and Project Director/Leader as required.
- Experience managing complex studies and/or general medicine studies is required.
- Please note that you must have CRO experience to be considered.
Skills
- Eight (8) years (at least) of clinical research experience in Project Management.
- Previous experience managing oncology and respiratory studies is required.
- Previous CRA experience is highly desirable.
- Previous CRO experience is required.
- Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
- Prior experience in electronic data capture preferred.
- Fluent in English.
- Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).
- The Application Process
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Benefits
- Assist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study Reports.
- Education, Experience and
Company info
- Join our global team and help improve peoples' lives!
Visa & Work Authorization
- Manage all project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc
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