Clinical Trial Manager

How you’ll make an impact:
- Contribute to planning, implementation, and execution of a global clinical trial
- Manage vendors to support clinical trial execution
- Plan, execute, and lead study-specific meetings (e.g., internal core team, investigator meetings)
- Provide input to design Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc.
- Provide study-specific training and leadership to clinical research staff, CRO, CRAs, sites, and contract personnel
- Manage study timelines and metrics to ensure completion of deliverables
- Support site selection, qualification, initiation, and monitoring activities
- Review monitoring reports and resolve site-related issues
- Ensure timely enrollment and data collection
- Collaborate with data management to ensure data integrity and timely database lock
- Review/analyze clinical trial data to identify trends and potential issues
- Track/review protocol deviations and assess impact
- Develop relationships with investigators and site staff
- Coordinate with CRO and Medical Monitor to summarize safety/efficacy data
- Partner with translational medicine on bioanalytical sampling plan incorporation and outputs
- Maintain accurate and complete trial documentation
- Proactively identify and resolve clinical project issues

Skills and experience you’ll bring:
- BS in Life Sciences; 3+ years (CTM) / 5+ years (Sr. CTM) as a project/clinical trial manager in biotech/pharma
- Experience on large, global, complex Phase 2 clinical trials
- Knowledge of regulatory and ICH GCP guidelines, HIPAA, and Protection of Human Research Subjects
- Strong project management (manage multiple trials)
- Excellent problem-solving, leadership, and communication skills
- Ability to work in a fast-paced, cross-functional environment

Compensation:
- Anticipated base salary: $115,000–$200,000; eligibility for annual bonus, equity, and comprehensive benefits