Clinical Research Project Manager

Job Description

The Clinical Research Project Manager leads and manages clinical trials through study execution and closeout, ensuring compliance with protocol requirements, institutional standards, and regulatory guidelines. This role provides operational oversight of research activities, including participant recruitment and retention, data and specimen management, and regulatory compliance. The Project Manager collaborates with the Study Start-Up team to support study initiation and ensure a smooth transition into study conduct. The role may also supervise research staff, drive process improvements, and provide guidance on clinical research operations and compliance.

Job Description Oversees clinical trial operations from study activation through closeout, including participant screening, recruitment, enrollment, consenting, data and specimen management, and preparation for monitoring visits, ensuring compliance with GCP and applicable regulations. Partners with the Study Start-Up team to support feasibility assessments, study planning, and activation readiness. May supervise, train, and mentor research staff, ensuring adherence to protocols, regulatory requirements, and institutional policies. Maintains study documentation, regulatory submissions, financial tracking, and quality control processes to ensure data integrity and audit readiness. Supports departmental research operations, contributes to process improvements and SOP development, and serves as a resource on clinical research processes and compliance.

Skills and Requirements

Bachelor's degree with 5+ years of clinical research experience OR Master's degree with 3+ years of clinical research experience Experience supporting patient-facing interventional drug trials Experience overseeing clinical trial operations, including protocol development, study management, and coordination across the study lifecycle Experience collaborating with Study Start-Up teams and supporting trials from initiation through closeout Direct experience working with research participants/patients Prior people management experience, including coaching, performance reviews, and team development Strong knowledge of Adverse Events (AEs), Serious Adverse Events (SAEs), Good Clinical Practice (GCP), and regulatory compliance Oncology experience

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].