Clinical Research Project Manager - Oncology/Immunology
• Manage and approve study budgets.
• Develop and oversee study operational plans.
• Assist with protocol design and strategy and medical issue resolution for assigned protocols.
• Participate in study data review and assist with patient narrative writing and other data review activities as assigned.
• Contribute significantly to relevant study documentation including clinical protocols, statistical analysis plan, and clinical study reports.
• Proactively identify project risks and resolve with some supervision.
• Participate in the selection of investigators and vendors.
• Ensure assigned studies adhere to all applicable regulations and requirements relevant to the study phase, design and / or use of data.
• Assist with maintaining metrics such as patient status and timelines for various activities pertaining to the clinical development program.
• Maintain close communication with all clinical patient sites for follow-up on patients at all stages of the clinical trial process, answering questions and escalating items to appropriate parties as required.
• Responsible for collection, dissemination, and / or tracking of final regulatory documents into appropriate archive systems as required.
• Attend all site meetings and vendor meetings, phone and in person, associated with ongoing clinical trials ensuring that proper follow up activities are identified and followed through on. May facilitate these meetings as required as lead project manager on certain sites or protocols.
• Manage CROs contracted services (regulatory, site management, etc) to ensure quality, timely performance and accountability on agreed to responsibilities, timelines & budgets.
• Perform all responsibilities in accordance with SOPs, established guidelines and work instructions, and appropriate industry and GCP standards.
• Assist and participate in KOL meetings as appropriate.
• Assist with regulatory submission preparations as appropriate such as annual DSUR for FDA.
• Participate in interdepartmental activities as necessary.
• Undergraduate Degree in Science Discipline.
• GCP Training.
• 10+ years of clinical trial experience.
• 5+ years of project management experience.
• Basic understanding of clinical drug development and GCP and familiarity with regulatory requirements for conduct of clinical trials.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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