Senior Clinical Trial Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Supervise and implement the operational components of one or more clinical studies, spanning protocol development to database lock.

• Oversee external vendors and contract research organizations.

• Develop study documentation in accordance with ICH GCP and Artiva SOPs.

• Coordinate and manage the creation of study materials, including CRFs, patient diaries, study participation cards, and source documents.

• Assist in the development of protocols, updates to the Investigator Brochure, and the completion of study reports.

• Manage monitoring activities via contractors or CROs, which may include occasional on-site clinical monitoring or co-monitoring with a CRA.

• Provide leadership, guidance, and management to CRAs directly or through CROs.

• Monitor patient enrollment; qualify, initiate, oversee, close out, and assess clinical study sites.

• Aid in coordinating data management tasks and addressing data inquiries.

• Review study quality metrics and collaborate with the study team to determine necessary actions.

• Organize study supplies and review/approve investigational product release packages.

• Negotiate contracts with clinical trial service vendors and assist in invoice reconciliation.

• Evaluate informed consent forms, CRFs, and other study-related documents.

• Plan and engage in investigator meetings.

• Ensure regulatory compliance with Artiva SOPs, FDA regulations, and ICH guidelines.

• Maintain the trial master file, ensuring it is up-to-date and accurate.

⛳️ Requirements

• BA/BS, nursing degree, or an advanced degree; a degree in the life sciences is preferred.

• Minimum of seven years of experience in clinical trial management.

• Strong preference for experience in Cell Therapy, Autoimmune, or Rare Disease.

• Previous experience managing personnel in a matrixed environment.

• Experience managing global clinical trials.

• Proven working knowledge of GCP, ICH guidelines, and FDA regulations.

• Ability to work autonomously as well as collaboratively within a team setting.

• Approximately 25% travel required, including occasional international travel.

• Proficiency with MS Office applications, including Word, Excel, PowerPoint, and Outlook.

• Exceptional oral and written communication skills.

• Strong organizational skills.

🏝️ Benefits

• Medical, Dental, and Vision coverage.

• Group Life Insurance.

• Long Term Disability (LTD) benefits.

• 401(k) Retirement Plan.

• Employee Assistance Program (EAP).

• Flexible Spending Account (FSA).

• Paid Time Off (PTO).

• Company-paid holidays, including a week off at year-end.

• Bonus.ly recognition program, allowing points to be exchanged for desired items.

• An entrepreneurial, highly collaborative, and innovative work environment.

• A company culture that is passionate, tenacious, innovative, transparent, and inclusive.