Role Description

• The Sr. Clinical Research Manager is responsible for leading teams to execute on all aspects of clinical trial management across the study life cycle from planning to execution to closure. They work with cross-functional partners to implement process improvements, execute high-quality evidence, and drive our strategic partnership with clients and customers. They also leverage project management expertise to guide projects under their direct leadership.
• Develop strong customer and client relationships ensuring appropriate expectations are met and exceeded.
• Help develop talent, set goals, align on expectations and drive accountability with direct reports as well as identify future strategic direction across clinical operations portfolio.
• Maintain up-to-date knowledge of regulatory requirements related to study management.
• Track and follow-through on process improvement projects as well as studies we are supporting.
• Determine study objective, strategy, scope and schedule to meet business needs.
• Able to effectively influence cross-functional team members and external medical professionals to ensure project deliverables are completed on time/budget.
• Able to see multiple viewpoints and build consensus to reach resolutions.
• Support the development of the Clinical Investigational Plan and supporting documents (ICF, Monitoring Plan, Data Management Plan, etc.) in consultation with the cross-functional project teams.
• May provide clinical training of investigators, center staff, and internal team members.
• May evaluate, analyze and validate all clinical data per data management plan for ongoing analysis and publications throughout study execution.
• May participate in the selection and management of CRO vendors and contractors.
• May provide oversight/review of monitoring reports, CTMS/eTMF process implementation, and lead special projects for the portfolio.
• Develop a high level of professional scientific technical and clinical expertise through familiarity with relevant literature, by attending scientific meetings, and by interacting with various inside/outside experts or departments/institutes.
• May develop and manage budgets for assigned clinical research projects.
• Prepare outlines, summaries, status reports, etc. for distribution and communication with other departments and executive leadership.
• Follow and help iterate Clinical SOPs, systems and processes ensuring quality study management.
• Perform other duties as assigned.
• Qualifications
• Bachelor’s degree in a life science or related field.
• A combination of experience and/or education will be taken into consideration.
• Minimum of 8 years of experience within a Contract Research Organization (CRO), biotech, or pharmaceutical company with significant clinical research experience.
• Minimum 2 years of people management experience.
• Knowledge of GCP, FDA, and other regulatory requirements related to trial management.
• Strong attention to detail and organizational skills.
• Good communication, interpersonal skills, and talent management skills.
• Healthy disdain for the status quo.
• Ability to thrive in a fast-paced and dynamic early-stage company work environment.
• Requirements
• This is a remote position and may be performed anywhere within the United States of America.
• Regular domestic travel will be required for site visits, company meetings, audits, etc.

Company Description