Senior Clinical Operations Manager

2 days ago

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Description

• Serve as the primary point of contact for industry sponsored clinical trials and assigned projects • Work closely with the Head of Research and Community Health Operations and Head of Endpoint and Specialty Services • Oversee clinical operations management activities when delegated to a Clinical Trial Manager (CTM) • Manage site identification, evaluation, initiation, contracting/budget negotiation, and site monitoring processes • Prepare central IRB submissions; oversee site IRB approvals and ensure collection of all new or expiring Investigator regulatory documents • Oversee the development of project-specific essential documents for site oversight • Review and finalize monitoring visit reports and follow-up letters with Clinical Research Associates (CRAs) • Manage and approve site payments as applicable • Contribute to process improvement and development of SOPs • Define and monitor project scope, timelines and deliverables

Requirements

• A Nursing or BA/BS in a scientific field (or equivalent knowledge/experience) • 5 years of experience in a clinical research setting (required) • 3 years of sponsor or CRO clinical research project/clinical operations management experience • Demonstrated ability to successfully execute all aspects of sponsor/CRO clinical trial management • Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials • Proficiency in Microsoft Office, particularly Outlook, Word and Excel • Excellent communication and organizational skills • Great attention to detail • Exemplary skills leading and managing multi-disciplinary teams in a clinical research setting • Ability to organize, instruct and supervise staff, while promoting group effort and achievement • Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively • Willingness to travel 20-25%

Benefits

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) • Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) • 11 paid holidays • 15 - 25 vacation days based on years of service • Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) • In-suite exercise and relaxation room • Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics) • Flexible and remote work schedules