Lead Clinical Project Manager

Globus Medical - San Diego, CA

Full-time - Senior

San Diego, CA

Miscellaneous Manufacturing

About the position

The Lead Clinical Project Manager (CPM) is responsible for overall coordination and management of assigned clinical studies and projects. They are accountable for the project scope, timelines, and budget to ensure key milestones are achieved and studies are performed within budget, on schedule and in compliance with the appropriate standards. The CPM also supports the generation of scientific manuscripts, abstracts and posters as needed.

Responsibilities

• Foster relationships with surgeons, sales representatives, and clinical teams to gain input into study design, evaluate study feasibility, and identify sites for study execution or data collection for the assigned study.
• Lead the designing and reviewing of all study documents for the assigned study, including the clinical study protocol in collaboration with Medical Affairs, case report forms and subject questionnaires, informed consent forms, electronic data capture (EDC) system, and other study tools.
• Set and manage project budgets, communicate deviations from budget projections, and propose solutions for budget deviations. Oversee timely processing of site payments for assigned study.
• Lead sponsor study start-up process, including but not limited to the conduct of the internal study kick-off meeting, finalization of site and vendor (as applicable) agreements/budgets, and site qualification.
• Oversee the study start-up process study-wide, including IEC/IRB submissions and related communications, such as study kickoff webinars or investigator meetings.
• Act as a corporate liaison with assigned study sites. Demonstrate a high level of product and procedure knowledge to support study-related questions and provide site training independently.
• Ensure site compliance with applicable regulatory requirements, including on-time submission of IEC/IRB reviews and communications, obtaining subject signatures on each applicable consent form (as applicable), and timely submission of sponsor-generated documents.
• Conduct remote and on-site monitoring including site qualification visits, site initiation visits, interim monitoring visits, and closeout visits. Activities associated with site visits include: with the study site prior to and after the visit, review IEC/IRB documentation, perform data verification in EDC, ensure protocol and follow-up visit compliance, and generate comprehensive monitoring reports in a timely manner.
• Together with Data Management, generate and ensure resolution of queries and track return. Work with team to create databases and data tracking tools. Ensure effective utilization of the EDC system.
• Identify, evaluate, and ensure all protocol deviations or violations and complications are properly documented and reported to the appropriate authority in the correct time frame, adequately followed, and communicated per company SOPs and regulatory requirements. Proactively seek solutions to mitigate future deviations or violations.
• Produce clear, accurate, and well-written documents and contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and Clinical Study Reports (CSR), as assigned.
• Act as the primary point of contact of leadership and oversight (as required) for the assigned study. Provide comprehensive updates on study status; communicate relevant information to research and other project team members, including Regulatory Affairs, Quality Assurance, Marketing, Product Development, Sales, Finance, and Legal.
• Oversee performance of CROs and third-party vendors to ensure compliance with study protocol and in accordance with scope of work and in accordance with corporate timelines.
• Lead problem solving and resolution efforts. Provide proactive and creative recommendations on how to meet goals and handle identified risks and deviations. Look for opportunities to expand and deepen clinical study process expertise across study teams and external partners and make decisions on process and issues affecting study implementation and execution.
• Maintain study data and files in accordance with ICH, GCPs, FDA requirements and company specific SOPs. Perform periodic audits of the Central Clinical Files.
• Contribute to the development of others by acting as a coach for peers as well as new CRAs, study team members, and business partners on aspects of clinical trial process and regional specificities while maximizing shared learning.
• Maintain strong understanding of evolving post-market evidence requirements (i.e., FDA and EU Medical Device Regulation (MDR)).
• Assist research and other project team members in additional responsibilities as required.

Requirements

• Understanding of medical terminology.
• Effective communication, organizational, interpersonal, and leadership skills.
• Working knowledge of FDA, EU MDR requirements, and ISO14155 for clinical trial conduct.
• Excellent computer skills, particularly with database applications are required. Proficient and accurate with word processing (Word), spreadsheets (Excel), presentation programs (PowerPoint), and EDC systems.
• Bachelor's degree in life science, biological science, or equivalent and 8+ years' experience in clinical trials. Demonstrated track record of effective clinical study site management.

Benefits

• Equal Employment Opportunity: Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees' talents and support an environment that is inclusive and respectful.