PTC Therapeutics - Remote, OR
posted about 2 months ago
The Contract, Clinical Operations role is pivotal in providing the scientific and operational expertise necessary for leading the execution of clinical trials throughout their complete life cycle. This position requires adherence to regulatory requirements for various indications across therapeutic areas. The incumbent will work as an integral member of the clinical team, managing clinical trials from study design through to closeout. This role involves cross-functional collaboration with internal departments and external resources to address Clinical Operations-related issues, ensuring compliance with relevant regulatory requirements and company Standard Operating Procedures (SOPs). In this position, the individual will perform a variety of essential functions, including leading, directing, and contributing to the planning, execution, and reporting of clinical trials. Responsibilities include estimating clinical project timelines, writing protocols, designing Case Report Forms (CRFs), selecting study sites, forecasting study drug needs, managing sites and Clinical Research Organizations (CROs), reviewing data, and reporting study outcomes. The role also involves interacting with both external and internal project team members to develop clinical strategies, trial designs, and project deliverables. The incumbent will meet with investigators and PTC scientific and clinical staff to gather direction and feedback, and will assist in evaluating scientific literature and investigator advice to inform clinical strategy and protocol development. The role requires the preparation of investigational site lists, participation in the review and approval of investigational sites, and negotiation of contracts and budgets with sites and vendors. The incumbent will also plan, coordinate, and conduct investigator meetings, responding to inquiries from sites and trial monitors regarding trial conduct. Managing clinical study timelines and developing budgets for clinical trial programs are key responsibilities, along with presenting project progress reports at internal team meetings and investigator meetings. The individual will facilitate regulatory submissions and communications, writing assigned portions of reports for submission to regulatory agencies, institutional review boards, scientific journals, and conferences. Ongoing review of clinical trial data is essential to ensure timely, consistent, and accurate data, assisting in the interpretation of clinical data for clinical study reports and regulatory submissions. Overall, this position requires a proactive approach to managing clinical trials, ensuring compliance with regulatory standards, and contributing to the successful execution of clinical research initiatives.