Clinical Trial Manager
2 weeks ago
CTM II Hybrid position | 2/3 days onsite located in San Diego, CA
Candidates are expected to manage and oversee all study-level vendor and site related activities and issues related to one or more clinical trials, as needed. The successful candidate must have experience managing Phase I-III trials and a good knowledge of clinical operations, GCP, and FDA regulatory environment.
Responsibilities
Manage all components of clinical trial(s), leading a cross-functional study team under the direction of the disease area lead.
Ensure clinical trial activities are completed on time, within budget and in a highly dynamic and complex environment in accordance with appropriate quality standards including ICH/GCP requirements and SOPs.
Lead the identification, evaluation, selection, and oversight of clinical trial sites.
Partner efficiently, effectively, and professionally with assigned Clinical Research Associates (CRA) and participating study sites to ensure smooth study conduct.
Author and implement operational plans to ensure efficient study enrollment and high-quality monitoring activities at clinical sites.
Review/approve vendor and site invoices and track study budget to forecast, working closely with finance and clinical business operations.
Responsible for implementation and oversight of Trial Master File for inspection readiness.
Drive overall process and provide support to cross-functional teams in the development of study documents including study protocols, consent forms and budget templates.
Serve as lead in the creation of project plans, logs, templates, newsletters, and other documents.
Review and approve site specific documents (such as informed consent forms, site budgets, monitoring reports) along with other relevant project team members.
Provide study updates and reports, inclusive of study risks and issues.
Lead internal and external meetings for assigned clinical trial(s), including Investigator Meetings, conferences, events, iDMC, and study management meetings.
Responsible for ongoing study data reviews and data cleaning activities.
Provide oversight of CTA and CRA activities such as site identification, qualification, selection, initiation, data quality, interim monitoring and close out activities.
Manage trial-level quality risk management.
Oversee study supplies management.
Support the development and complete the delivery of study training to investigators, site staff and internal staff on study processes.
Participate in the preparation and follow up of internal process audits, vendor, and study site quality audits as well as regulatory inspections.
Lead on-site/remote site booster visits.
Qualifications
B.S. degree with a minimum of 7 years of experience managing clinical trials in biotech, pharmaceutical, and/or CRO environment.
Oncology or autoimmune experience required.
Immunotherapy or cellular therapy experience preferred.
Strong working knowledge of clinical operations and experience with clinical study conduct from start-up through close-out, with global trials or CRO management experience preferred.
Management experience of project teams along with the ability to lead cross functional study teams.
Effective communication skills and professional demeanor; ability to work in a team environment with medical personnel, clinical monitors, statisticians, data managers, medical writers, and internal cross-functional team members.
Working knowledge of FDA/ICH guidelines and industry/technology standard practices including Good Clinical Practices; trial initiation and management practices and procedures.
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