Hybrid Clinical Project Manager

at Contineum Therapeutics

• Job title: Clinical Project Manager
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: $138,000 - $152,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, United States

About the role

• Clinical Project Manager overseeing planning, execution, and delivery of clinical studies. Ensuring compliance and collaboration across teams in a remote setting.

Responsibilities

• Contribute to the planning, execution, and oversight of aspects of global and/or regional clinical studies from study start-up through database lock and final CSR
• Ensure timely delivery of key clinical trial deliverables and milestones, including site selection and activation, FPI, LPI, subject retention, data review, database lock, site closeout, TLF delivery, CSR, and TMF delivery
• Closely oversee and coordinate vendor activities. Contribute to vendor selection and management. Act as a primary point of contact between the sponsor and CROs or vendors.
• Coordinate problem-solving of vendor, site, and internal issues
• Contribute to the development of clinical protocols. Review informed consent forms, case report forms, study plans and other documents for harmonization and consistency.
• Comply with internal SOPs, ICH/GCP guidelines, and other regulatory requirements
• Communicate study status and escalate issues to clinical management and the organization cross-functionally as required
• Collaborate with internal stakeholders to ensure mutual cross-functional support to meet company objectives
• Plan, prepare, and present as needed at internal and external meetings

Requirements

• Bachelor's or higher degree in a scientific discipline
• Minimum of 5 years of experience in clinical development with experience in clinical operations preferred
• Proficiency with standard software platforms
• Dedication to quality and reliability, including thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines
• Strong organizational and multitasking skills
• Excellent written and verbal communication and interpersonal skills.
• Friendly, with the ability to develop collaborative relationships in an often remote online team environment

Benefits

• 90% employer-covered benefits
• Flexible PTO
• A very generous holiday schedule that includes a week off in August and time off around the winter holidays
• A well-stocked kitchen with snacks and beverages
• Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match.
• The comprehensive wellness program includes medical, dental, vision, and LTD coverage.