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Senior Clinical Trial Manager
Vera Therapeutics, Inc.. Manage all clinical operational aspects of a global clinical trial, including start-up, conduct, and close-out activities .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trial operations, ensuring compliance with GCP, ICH guidelines, and FDA regulations while fostering cross-functional collaboration. Proven ability to develop innovative solutions and lead teams to achieve clinical development goals in a fast-paced environment.
Highest-signal resume keywords
Clinical Trial ManagementGCP ComplianceCross-Functional LeadershipClinical Operations ExperienceRegulatory Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical DevelopmentProtocol WritingStudy DesignRisk ManagementData Quality Assurance
Soft Skills
Interpersonal SkillsCommunication SkillsOrganizational SkillsProblem-Solving SkillsMentoring
Tools & Technologies
MS OfficeClinical Trial Management Systems
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryRare DiseasesInflammatory DiseasesInspection Readiness
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Manage all clinical operational aspects of a global clinical trial, including start-up, conduct, and close-out activities
- Monitor assigned trials for adherence to GCP, protocols, SOPs, and key performance indicators
- Oversee CROs and clinical sites and serve as the primary CRO/vendor contact
- Identify study issues and risks and recommend or implement solutions
- Support CROs in generating quality, accurate data and resolving issues
- Manage study timelines in alignment with corporate and cross-functional goals
- Contribute to writing, reviewing, and finalizing protocols and clinical study reports
- Prepare metrics and updates for Vera management
- Organize and lead clinical operational and study team meetings
- Develop relationships with principal investigators, clinical opinion leaders, and sites
- Contribute to RFP development, CRO/vendor selection, and review of CRO budgets or change orders
- Develop cross-functional relationships and provide leadership to ensure efficient trial execution
- Ensure site and CRO adherence to SOPs, regulations, GCP, and ICH guidelines
- Contribute to or review study plans, ICFs, site manuals, patient materials, CRF completion guidelines, and system specifications
- Attend or present at Investigator Meetings as needed
- Travel up to 30% as needed to support clinical development programs
Requirements
What you’ll need- BS or higher in life sciences or health-related field
- 5+ years clinical development experience and progressive experience in clinical research within the pharmaceutical or biotechnology industry
- Rare disease and inflammatory diseases and/or difficult enrolling study experience preferred
- Regulatory filing and experience with inspection readiness preferred
- Experienced in managing, mentoring, and developing junior staff
- Flexible self-starter to operate in a fast-paced start-up environment
- Ability to develop out of the box solutions with limited infrastructure
- Experience in all aspects of clinical operations
- Working proficiency of GCP, ICH guidelines and FDA regulations
- Ability to work independently as well as collaboratively in cross-functional team environment
- Proficiency with MS Office (Word, Excel, PowerPoint, Outlook, Project)
- Strong interpersonal skills with excellent oral and written communications
- Innovative, analytical, and extremely organized to drive projects to completion
Benefits
Comp & perks- Annual performance incentive bonus
- New hire equity
- Ongoing performance-based equity
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) match
- Flexible time off
- Paid holidays