Clinical Project Manager

Laborie Medical Technologies Corp • Minnetonka, MN

1d

About The Position

As a key member of the Clinical team, the Clinical Project Manager (CPM) is responsible for the management of all aspects of Clinical Trial Team activities for assigned project(s). The CPM, in concert with the Clinical Program Manager, is accountable for achieving successful delivery of Laborie Clinical Team activities at the project level by meeting company and regulatory requirements according to time, quality/scope, and budget constraints.

Requirements

• Bachelor's degree in Life Sciences; Master's or Doctoral degree preferred.
• 8+ years of clinical operations experience for CPM; with increasing levels of responsibility in the medical device or CRO industry is required.
• Minimum 2 years of clinical project management experience at a sponsor or CRO company is preferred.
• Therapeutic/intervention experience in urogynecology, gastroenterology, and/or OB/GYN.
• Experience with medical devices CER, PMS, PMCF, PSUR medical writing.
• Speak fluent English, excellent verbal and written communication skills, Microsoft Office, Excel, PowerPoint, Outlook, Teams, etc.
• Must have thorough knowledge of clinical research concepts, practices, and FDA/EU regulations and ICH Guidelines, ISO 14155, clinical research, and data management methods.

Responsibilities

• Proactively manage project level operational aspects of Clinical Research Team (CRT) including management of trial timeline, budget, resources, and vendors.
• Provide efficient updates on trial progress to the Clinical Program Manager and/or Chief Technology Officer, with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
• Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the setup of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
• Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Research Team to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
• Chair Clinical Research Team working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members, and filed in the Trial Master File (TMF) in a timely manner.
• Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution, and quality control across the clinical team.
• Review and approve vendor invoices in collaboration with the accounting team to ensure investigator payments occur in a timely manner.
• Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
• Effectively provide support to the Clinical Research Team in the conduct of the trial(s).

Benefits

• Paid time off and paid volunteer time
• Medical, Dental, Vision and Flexible Spending Account
• Health Savings Account with Company Funded Contributions
• 401k Retirement Plan with Company Match
• Parental Leave and Adoption Services
• Health and Wellness Programs and Events

What This Job Offers

• Job Type: Full-time
• Career Level: Senior