Clinical Project Manager

The Clinical Project Manager (CPM) will be responsible for independently managing internal and outsourced (CRO) aspects of US and/or global clinical studies. The CPM will report to a Director-Level team member in Clinical Operations. The ideal candidate would reside on the West Coast of the United States and could come into the San Diego office monthly or work hybrid if local.

Key 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:
We offer a competitive total compensation package, as well as working in a supportive team environment. The anticipated salary range for candidates is $138,000- $152,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Contineum offers competitive compensation and benefits, including:

• 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.