- Proactively manage project-level operational aspects including but not limited to study status, client communications and inquiries, kit requirements/delivery/inventory, agreement facilitation, and coordination with the R&D laboratory as needed.
- Provide efficient updates on trial progress to the DRO and other leadership members as needed, with respect to study and test status, kit inventory, and client communications and inquiries.
- Assumes primary accountability for assigned projects and initiatives and ensures compliance with applicable federal, state and academic regulations, and corporate policies for study activities.
- Serves as a liaison between clients, vendors, sites, collaborators, and internal team members (R&D, finance, other) to ensure project specific information and ongoing updates are proactively communicated.
- Lead sponsor study startup process, including but not limited to conduct of the Study Kick-off meeting, study document creation and distribution, and initial kit delivery.
- Work proactively with the R&D team to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), HIPAA/ICH/GCP guidelines and regulatory requirements.
- Ensure potential study risks are escalated to the attention of the DRO or CSO when appropriate.
- Ensures that all project tasks are completed in accordance with the contract, trial/project protocol, and Standard Operating Procedures (SOPs).
- Provides administrative management and support for the receipt, shipment, and monitoring of study/project related samples and test results.
- Responsible for tracking the completion of project-specific milestones and deliverables; responsible for reporting on project-specific metrics to leadership.
- Monitors adherence to project contract and budget
- Review and approve client invoices in collaboration with the Accounting team to ensure investigator payments occur in a timely manner.
- Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements
- Effectively provide support to internal and external customers in the conduct of the studies.
- Capture, manage, and distribute meeting minutes and study activities as needed.
- Maintain departmental and organizational reputation of excellence through timely, quality-focused, proactive project support.
- Other duties as assigned.
- 5-10 years experience in clinical research with the most recent role being at a for-profit life sciences company or contract research organization.
- Preference for candidates with experience in clinical research and/or diagnostics.
- Project management experience required.
- Proven track record managing day-to-day activities of multiple and multi-site studies.
- Strong familiarity with project management, alliance management, site management, and related areas.
- Proven ability to work independently in fast-paced environment.
- Proven multitasking skills.
- Excellent communication and analytical abilities.
- Bachelor's degree in Life Sciences at a minimum; Project Management certification a plus; Master's degree a plus
- CITI research training as needed
- This is a hybrid position based at our company headquarters in Scottsdale, AZ. The employee will be expected to work in the office for three (3) days per week and may choose to work remotely for the other two days.
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Clinical Project Manager - Scottsdale, United States - CND Life Sciences
Description
Job Description
Job DescriptionThe Clinical Project Manager (CPM) coordinates, executes, and reports on industry and academic study operations. The CPM acts as the liaison between the sponsor, academic collaborators, 3rd party vendors, CND team members, and sites while overseeing projects and ensuring quality service. The CPM is responsible for the management of Investigator Initiated Trials (IITs), Clinical Trial Services, and, as assigned, R&D projects related to generating evidence of the impact of CND's diagnostic technology in a real-word setting. This position coordinates with the Research and Development (R&D) laboratory and CND Logistics and Production department to understand, evaluate, coordinate, and delivery exceptional project support and management. The CPM maintains a high level of quality through communication, customer service, and organizational practices. The CPM, in concert with the Director, Research Operations (DRO) is accountable for achieving successful delivery of the Research Operations activities at the project level in a timely, efficient, quality, and budgetarily appropriate manner while meeting company and regulatory requirements.
Job Responsibilities:
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