Senior Clinical Trials Manager

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

📋 Description

• Oversee the activities of multiple global clinical studies.

• Aid the Clinical Project Manager in the development and management of company-sponsored global clinical trials.

• Evaluate the completed tasks of the clinical development team members.

• Create and manage updates to informed consent documents, laboratory manuals, pharmacy manuals, case report forms (CRFs), and other tools for study execution.

• Support the processes of site recruitment, initiation, payments, and close-out.

• Supervise the training of new clinical site personnel and provide training for protocol amendments.

• Coordinate with the internal team to gather updated regulatory documents.

• Offer daily support to clinical sites regarding protocol interpretation and compliance with safety standards.

• Educate staff within the clinical development group.

• Compile and refresh clinical trial updates for the Clinical Development team.

• Summarize and manage patient treatment, response, and survival data for ongoing studies.

• Develop, revise, and comply with Standard Operating Procedures (SOPs), process enhancements, and standardized templates.

• Undertake ad-hoc and cross-functional duties and projects as assigned.

⛳️ Requirements

• A Bachelor's degree with 7+ years of pertinent experience in clinical research is required.

• Proficient in MS Word, Excel, PowerPoint, and Outlook.

• Exceptional written and verbal communication skills.

• Strong organizational abilities and capacity to manage multiple tasks simultaneously.

• Knowledge of and adherence to job-specific systems, processes, and company SOP requirements.

• Commitment to maintaining corporate confidentiality at all times.

• Capability to work in a typical office environment and use standard office equipment, including a computer.

• Ability to lift and carry materials weighing up to 20 pounds.

• Willingness to travel approximately 20% of the time.

🏝️ Benefits

• Chance to join a publicly traded biopharmaceutical company.

• Collaborative team environment with opportunities to work across various departments.

• Opportunities for professional development.

• Discretionary bonus.

• Equity award.

• Options for Medical, Dental, and Vision Plans.

• Health and Financial Wellness Programs.

• Employer Assistance Program (EAP).

• Company Paid and Voluntary Life/AD&D insurance.

• Short-Term and Long-Term Disability coverage.

• Flexible Spending Accounts for Healthcare and Dependent Care.

• 401(k) Retirement Plan with Company Match.

• 529 Education Savings Program.

• Voluntary Legal Services, Identity Theft Protection, Pet Insurance, and Employee Discounts, Rewards, and Perks.

• Paid Time Off (PTO), including 11 Holidays.

• Unlimited PTO for Exempt Employees.

• 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days, and 1 Cultural Day for Non-Exempt Employees.

• Access to tools and resources aimed at optimizing Health and Wellness.