Clinical Trial Manager
We are seeking a qualified professional to join the Clinical Operations team at Catabasis. The role will be a key contributor to the company’s clinical development and primarily responsible for the hands-on management and monitoring of clinical studies in either the cardiometabolic or muscular-skeletal-related clinical therapeutic areas. This position reports to the Senior Director, Clinical Operations.
- Oversee the management of the overall activities of relevant CROs, vendors and monitors;
- Oversee the evaluation of potential clinical investigators and sites
- Oversee the development and coordinates review of key deliverables, such as the study synopsis, protocol, informed consent forms, study guidelines, operations manuals; CSRs
- Maintains study timelines
- Manage escalation of study related issues and establishes appropriate course of action
- Proven track record of anticipating potential study issues and preparing contingency plans with minimal oversight
- Responsible for the conduct of training and kick-off meetings with sites and vendors
- Analyze and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sites and vendors
- Minimum 5 yrs. [senior CRA] and 6-8 yrs. [manager level] experience of biotech / pharmaceutical clinical operations experience
- Experience in managing the execution of complex phase 1-3 clinical trials from the biotech / pharma side in clinical operations
- Strong experience oversight / management of CRO and vendors to support clinical trials
- Strong knowledge of FDA regulations and GCP / ICH guidelines regarding clinical trial management
- Ability to “roll up your sleeves” and individually contribute results to clinical operations and company-wide goals
- Demonstrated skills in writing/reviewing clinical study protocols, CRF, and study documentation development, CSR’s, regulatory documents (including IND, CTA documents and annual/periodic updates).
- Bachelor’s degree in health sciences or related field, required; Master’s preferred.
- Superior verbal and written communication and interpersonal skills, including a positive and professional attitude to tasks and projects
- Demonstrated ability to meet short-term deadlines and multi-task in a very fast-paced work environment with little direct supervision
- Demonstrated computer skills using MS Office Suite (Word, Excel, PowerPoint, Outlook and Project) software
- Ability to travel domestically and internationally
- Position is office based in Cambridge, MA.