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INSIGHTEC · 2 months ago

Clinical Project Manager

FL, Miami, US

Full-time

Hybrid

Senior Level

7+ years exp

Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery. The Clinical Project Manager will lead clinical trial initiatives, ensuring compliance, regulatory alignment, and operational efficiency while collaborating with cross-functional teams. This role involves managing multiple clinical trials, overseeing documentation, and ensuring adherence to study timelines and budgets.

BiotechnologyHealth CareManufacturingMedical DeviceTherapeutics

Comp. & Benefits

Responsibilities

Lead and manage multiple clinical trials from initiation through to completion, ensuring adherence to study timelines and budgets

Collaborate with investigators, vendors, and cross-functional teams to ensure study execution and operational excellence including implementation of best practices such as quality by design

Oversee the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and clinical study reports

Support creation of investigator brochures, clinical evaluation reports, publications and other documentation such as annual reports as applicable

In partnership with R&D Program Management, develop and drive cross functional study timelines related to trial setup and execution

Drive the cross functional internal study team ensuring appropriate alignment, risk management and coordination across all participating functions

Successfully interface with Data Management, Biostatistics and Clinical Monitors to ensure seamless monitoring and data cleaning initiatives to meet study deliverables and timelines

Foster a collaborative team environment focused on operational efficiency and continuous improvement

Ensure that clinical trials are conducted in compliance with all applicable regulations and ISO 14155 and ICH-GCP guidelines as applicable

Lead submissions of clinical trial documents to central IRB/IECs as applicable and ensure insurance and recruitment materials are prepared appropriately

Support the preparation and submission of clinical trial applications, including IDEs, PMAs, 501K, INDs, and other regulatory documents with functional leads from regulatory affairs

Manage interactions with Regulatory Affairs and external vendors to ensure timely submissions and approvals

Develop and manage clinical trial budgets, ensuring efficient use of resources and timely financial reporting

Monitor and control trial costs to ensure alignment with project forecasts and company objectives

Negotiate contracts and budgets with clinical vendors and investigators

Oversee the selection and management of clinical research sites and clinical vendors (CROs, laboratories, etc.) and ensure they meet performance expectations

Develop strong relationships with clinical sites and external partners to ensure aggressive site startup, high-quality data collection and trial conduct

Perform risk assessment and management, addressing issues proactively to mitigate operational issues

Qualification

Clinical Project ManagementRegulatory ComplianceClinical Trial DesignBudget ManagementData ManagementLeadership SkillsEnglish FluencyOral PresentationTeam Management

Required

Bachelor's or Master's degree in life sciences or a related field

7+ Years of experience as a Clinical Project Manager for Class II/III device studies

3+ years of regulatory/clinical trial experience in the medical device industry

Demonstrates working knowledge of clinical trial design

Minimum of three years of experience developing clinical documents including protocols, informed consent, clinical study reports, and investigator brochures among other documents

Knowledge of financial principles in budgeting, budget negotiation, & contracts management

Demonstrates data management skills, tracking study metrics, and adherence to study protocol

Fluent in English with oral presentation and training capabilities

Able and willing to travel as needed, up to 30%

Expertise in GCP and regulatory requirements

Strong leadership and team management skills