Clinical Project Manager

Laborie; Minnetonka (MN); Presencial; USD 110.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Paid time off

Medical, Dental, Vision benefits

Health Savings Account with company-fn

401k with company match

Parental leave

Descripción de la vacante

Laborie is seeking a Clinical Project Manager to oversee all aspects of Clinical Trial Team activities for assigned projects. You will manage timelines, budgets, resources, and vendors, coordinating with the Clinical Program Manager and CTO to meet regulatory requirements.

The role requires extensive clinical operations experience in the medical device field, strong English communication, and proficiency with ICH/GCP and TMF processes. Collaboration and leadership are essential.

Formación

• Bachelor's degree in Life Sciences required; advanced degree preferred.
• 8+ years of clinical operations experience in medical devices or CRO industry.
• Minimum 2 years of clinical PM experience at sponsor or CRO.
• Experience with regulatory medical writing (CER, PMS, PMCF, PSUR).
• Fluent English with strong written and verbal communication; proficient in MS Office.

Responsabilidades

• Manage trial timelines, budgets, resources, and vendors at the project level.
• Provide trial progress updates to Clinical Program Manager and CTO; oversee vendor selection and budgets.
• Lead sponsor startup activities: K.O. meeting, TMF setup, site and vendor agreements.
• Ensure SOP-compliant, ICH/GCP-regulated trial plans and TMF filing and maintenance.
• Chair meetings, distribute minutes, monitor vendor deliverables, and address quality issues.
• Review and approve vendor invoices to ensure timely investigator payments.
• Support TMF filing, maintenance, and archival procedures across trials.
• Assist Clinical Research Team in trial conduct.

Conocimientos

English fluency

Communication skills

MS Office

Educación

Bachelor's degree in Life Sciences

Master's or Doctoral degree preferred

Herramientas

Laboratory/Clinical software

Descripción del empleo

We believe that great healthcare is an essential safeguard of human dignity. A t Laborie, we know the work we do matters - it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you. We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We're not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.

Who We’re Looking For:

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). TheCPM, 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.

About the Role:

• 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).

Minimum Qualifications:

• 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.

Why Laborie:

• 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
• Awarded 2025 Cigna Healthy Workforce Designation Gold Level

Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.