Senior Clinical Trial Manager

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

📋 Description

• Oversee all clinical operational components of a global clinical trial, including initiation, execution, and closure activities.

• Supervise assigned trials to ensure compliance with GCP, protocols, SOPs, and key performance indicators.

• Manage CROs and clinical sites, acting as the primary liaison for CRO/vendors.

• Identify challenges and risks in the study and propose or implement solutions.

• Assist CROs in producing high-quality, accurate data and resolving any issues.

• Oversee study timelines to align with corporate and cross-functional objectives.

• Participate in writing, reviewing, and finalizing protocols and clinical study reports.

• Prepare metrics and updates for Vera management.

• Organize and facilitate clinical operational and study team meetings.

• Build relationships with principal investigators, clinical opinion leaders, and site personnel.

• Assist in the development of RFPs, selection of CROs/vendors, and review CRO budgets or change orders.

• Foster cross-functional relationships and provide leadership to ensure efficient execution of trials.

• Ensure compliance of sites and CROs with SOPs, regulations, GCP, and ICH guidelines.

• Contribute to or review study plans, informed consent forms (ICFs), site manuals, patient materials, CRF completion guidelines, and system specifications.

• Attend or present at Investigator Meetings as necessary.

• Travel up to 30% as required to support clinical development initiatives.

⛳️ Requirements

• Bachelor’s degree or higher in life sciences or a health-related field.

• At least 5 years of clinical development experience with progressive roles in clinical research within the pharmaceutical or biotechnology sectors.

• Experience in rare diseases and inflammatory diseases, along with challenges in study enrollment, is preferred.

• Familiarity with regulatory filing and readiness for inspections is preferred.

• Proven experience in managing, mentoring, and developing junior staff members.

• A self-motivated individual capable of working in a dynamic start-up environment.

• Ability to devise innovative solutions within limited infrastructure.

• Comprehensive experience in all facets of clinical operations.

• Working knowledge of GCP, ICH guidelines, and FDA regulations.

• Capable of working both independently and collaboratively in a cross-functional team setting.

• Proficient in MS Office applications (Word, Excel, PowerPoint, Outlook, Project).

• Strong interpersonal skills with excellent verbal and written communication abilities.

• Innovative, analytical, and highly organized, driving projects to completion.

🏝️ Benefits

• Annual performance incentive bonus.

• Equity for new hires.

• Ongoing performance-based equity awards.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) matching contributions.

• Flexible time-off policies.

• Paid holidays.