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Clinical Project Manager II
ClinChoiceClinical Project Manager II at ClinChoice overseeing clinical studies. Responsible for study execution, tracking, and vendor management with a focus on oncology and hematology trials.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Organizes and participates in Monitor’s and Investigator’s Meetings.
- Performs, if necessary, co-monitoring visits for the assigned clinical projects.
- Carries out, after appropriate and documented training/past experiences, the monitoring of the sites for the assigned projects, when requested and if applicable.
- May act as Feasibility Associate (FEA) after appropriate and documented training.
- Review and approve third party invoices for payment. Review and approve contractor timesheets for alliance with agreed scope of work.
- Develop and implement alternative solutions to problems with study timelines, resources, budgets, etc.
- Ensure issues are identified and communicated by the study team. Implement corrective action plan to prevent repetition of critical issues.
- Assess scope of work and timelines against contractual agreements and identify change orders pro-actively.
- Manage any deviations on resources and hours spent on the project to be able to evaluate the project progress and profitability and identify change orders in a timely manner and implement corrective actions. Ensure budget discrepancies are documented.
- Submit invoice requests, trial related invoices and payment authorizations to finance in a timely manner.
- Regularly track all expenditure and review for consistency with trial budgets.
- Organize quality check of filing of key study documentation.
- Ensure all administrative close-out procedures are completed.
- Follow and comply with the Company’s QMS, ISMS and PIMS requirements.
Requirements
What you’ll need- University Degree in scientific, medical or paramedical disciplines.
- 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.
- Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
- Experience managing complex clinical studies-oncology and hematology required.
- Excellent English communication skills:written and verbal.
- Proficient in the use of computer software systems (Word, Excel, PowerPoint, Microsoft Project, Share Point, CTMS, timesheet software, EDC software, etc.).
- Ability to travel as required.
Benefits
Comp & perks- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Project ManagementClinical Trial MonitoringBudget ManagementRegulatory ComplianceProblem Solving
Soft Skills
CommunicationOrganizational SkillsTeam Collaboration