Senior Clinical Trial Manager
$145,000–$170,000 year
On-siteCambridge, Massachusetts, United States or Cambridge, England, United Kingdom
Job Summary
Manage early-phase clinical studies from start-up to close-out, overseeing site monitoring, CRO management, and trial master file maintenance while adhering to GCP and ICH guidelines. Develop budgets and timelines, participate in creating study protocols and templates, and track lab sample transfers. Proactively resolve issues, manage Safety Review Boards and Data Monitoring Committees, and oversee vendor selection and negotiations. Represent the company externally and travel to investigative sites as needed to support gene editing therapeutics for rare genetic diseases.
Required Qualifications
- Bachelor's degree
- 6+ years or relevant and progressive clinical operations experience working in the pharmaceutical and/or biotech industry, preferably a mix of both
- Experience managing early-phase clinical studies in rare diseases
- Solid well-grounded experience in setup, execution and operational management of US and global clinical trials (delivered on time, within budget, and with high quality)
- Experience in ethics and regulatory dossier submissions (e.g., pre-IND, IND, Scientific Advice, CTA)
- Strong knowledge of GCP/ICH, drug development process, and other relevant guidelines for clinical research activities
- Proven track record of experience working with CROs, functional service providers and third-party vendors; strong contract negotiation abilities and thorough understanding of all financial aspects of contracts
- Proficient project management skills (e.g., Smartsheet, MS office or equivalent)
- Scientifically adept and great communication and interpersonal skills
- Knowledge of mRNA, RNAi, gene therapy or gene editing therapeutics and familiarity with LNP or AAV-based drug development
- Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members
- Excellent planning, organization, and time management skills
- Flexibility to travel domestically and internationally as required
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