Clinical Project Manager II
C
ClinChoiceClinical Research CRO
Remote, USFull-TimeManager
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- Three (3) years (at least) of Project Management experience in the CRO/Pharmaceutical industry or six (6) years (at least) of experience as CM/CRA in a CRO/Pharmaceutical industry.
- Required Skills
- GCP
Requirements
- University Degree in scientific, medical or paramedical disciplines.
- 3+ years of PM experience in CRO/Pharma OR 6+ years as CM/CRA in CRO/Pharma.
- Prior CRO experience (required).
- Expertise in complex oncology and hematology clinical trials.
- Excellent knowledge of clinical trial operations and GCP/ICH Guidelines.
- Excellent written and verbal English communication skills.
- Proficiency in Microsoft Project, Word, Excel, PowerPoint.
- Proficiency in SharePoint, CTMS, and EDC software.
- Ability to travel as required.
Responsibilities
- Organizes and participates in Monitor’s and Investigator’s Meetings.
- Performs co-monitoring visits if necessary.
- Monitors sites for assigned projects when requested.
- Acts as Feasibility Associate (FEA) after training.
- Reviews and approves third party invoices and contractor timesheets.
- Develops and implements alternative solutions to issues with study timelines, resources, or budgets.
- Ensures issues are identified and communicated; implements corrective action plans.
- Assesses scope of work and timelines against contractual agreements.
- Manages project resources, hours, and profitability to identify change orders.
- Organizes quality check of filing of key study documentation.
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