Job Details
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.