Reporting to the Senior Director of Clinical Operations, based in Foster City, the Clinical Trial Manager (CTM) responsibilities will include managing and meeting clinical trial milestones in compliance with applicable clinical and regulatory standards with the alignment of business needs.
The CTM is accountable for clinical trial management, including Clinical Research Organization (CRO), vendor, and/or cross-functional team meeting management and representation as a study lead. This position works in a cross-functional environment to contribute to corporate goals to progress the company’s portfolio of products. This work is accomplished with moderate supervision and requires a motivated individual who takes initiative and can work independently with minimal supervision upon project assignment.
Primary Duties and Responsibilities
- Manage study start-up, maintenance, and closure activities. Monitor subject enrollment metrics.
- Management of designated activities outsourced to CROs and vendors.
- Interface with cross-functional leads to ensure clinical trial progress, including project management of cross-functional meetings and issue escalation.
- Participate in the development of Investigator’s Brochures clinical trial protocols, amendments, informed consent forms, annual progress reports, clinical study reports and other documents as needed or requested.
- Develop and review required clinical documents, including Monitoring Plans, Case Report Forms, Protocol Deviation Management Plans, and other documents as needed.
- Review monitoring visit reports ensuring clinical trial site performance, quality, and compliance. Identify, troubleshoot and resolve issues pertaining to site monitoring.
- Conduct pre-study qualification, site initiation, interim monitoring, and close-out visits as needed to ensure appropriate training, clinical quality, and data integrity.
- Perform clinical trial-specific tasks such as contract negotiation and review of regulatory documents for site activation and investigational product release.
- Provide support for medical monitoring, data management, safety, and biostatistics as necessary. Review and evaluate clinical trial data on an ongoing basis to ensure subject safety and protocol compliance.
- Vendor and/or clinical trial site invoice tracking, review, and approval.
- Ensure that clinical trials are in compliance with relevant procedures and industry guidance, e.g., Code of Federal Regulations (CFRs), International Conference of Harmonization (ICH) Guidelines, and Good Clinical Practices (GCP), and appropriate industry standards.
- Ensure clinical trial audit readiness at all times, including ongoing Trial Master File development and review.
- Participate in the development of clinical and corporate procedures.
- Regular communication with executive management.
- Perform other duties as assigned by management.
- Minimum Bachelor’s Degree in a scientific field of study.
- Minimum of 6 years of clinical trial experience or relevant experience in the medical / scientific area, including demonstrated skills and competency in study management and monitoring.
- Thorough working knowledge of FDA and international regulations, including CFRs, ICH Guidelines, GCP and the clinical trial strategy.
- Experience with clinical protocol design, clinical trial operations, and clinical trial logistics.
- Understanding of data management, manufacturing, regulatory, safety, and statistical programming sufficient to communicate effectively with cross-functional team members.
- Understanding of clinical trial vendor and site contracts, invoicing and payments.
- Comfort in a start-up environment. Thrives in a fast-paced, highly collaborative, multi-disciplinary team setting.
- Ability to travel up to 10% domestically and internationally.
- Ability to manage, prioritize, and organize clinical trial projects with minimal supervision.
- Ability to train and mentor junior staff.
- Strong attention to detail.
- Strong written, oral, and interpersonal communication skills.
- Computer skills, including Microsoft Office Suite.
Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to eradicate cancer globally. The company’s existing pipeline consists of five development-stage assets including two novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and three targeted therapies against uncontrolled growth signaling pathways.