About the Role: The Senior Clinical Trial Manager will be at the forefront of our early phase studies. The role will report into the Senior Director of Clinical Operations and will be in a highly visible role for a novel class of gene editing therapeutics in rare genetic diseases. The role will be a key contributor to implementing and executing clinical trials from start-up to close-out. The role will be accountable for clinical trial management, trial master file, site monitoring, study start-up activities, and CRO management.
What You Can Expect:- Overall responsibility for the management of clinical study sites and external vendors while adhering to budget, scope and schedule requirements in accordance with GCP and ICH guidelines
- Develop and effectively manage budgets and timelines for assigned clinical studies
- Participate in the development clinical operations study plans, study templates and SOP/WI
- Participate in creation and review of study protocols, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Statistical Analysis Plans (SAPs), Clinical Study Reports (CSRs), and other clinical documents to ensure seamless integration between clinical objectives and study performance
- Assist in management of cross functional study teams and establishing/maintaining key internal and external stakeholder relationships to ensure study milestones are met
- Track and oversee lab sample transfers from patients to sites to clinical lab vendors
- Proactively identify and resolve issues and manage escalation as appropriate
- Manage timelines for Safety Review Boards, Data Monitoring Committee and Data Cuts
- Oversee maintenance of trial documentation and master file, data validation, and completion guidelines
- Participate in vendor review, selection, and negotiations
- Assist in planning and execution of Investigator Meetings as required. Establish working relationships with clinical and internal and external medical experts to optimize and implement clinical studies
- Represent the company externally and travel to investigative sites as needed
What You Bring: - Bachelor's degree and 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
- Motivated individuals who want to roll up their sleeves and apply drug development knowledge and experience to develop gene-editing therapies in a startup environment
- Flexibility to travel domestically and internationally as required
The anticipated salary range for candidates for this role will be $145,000 - $170,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, industry knowledge, technical skills, and other factors that may prove relevant during the interview process.
