Senior Clinical Trial Manager / Clinical Program Manager, Clinical Operations

Location
94404, Foster City
Posted
Jan 26, 2021
Ref
ClinOps012621
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

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.

Senior Clinical Trial Manager / Clinical Program Manager, Clinical Operations

Based in Foster City, reporting to the Sr. Director, Clinical Operations, the Senior Clinical Trial Manager (SrCTM) or Clinical Program Manager (CPM) will be responsible for managing and meeting clinical trial milestones in compliance with applicable clinical and regulatory standards with alignment of business needs.

The Sr. CTM/CPM is accountable for clinical trial management, including Clinical Research Organizations (CROs), vendors, 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 minimal 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.
  • Function as Global Lead and/or Regional Lead in EU and other territories as needed.
  • 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 to ensure clinical trial site performance, quality, and compliance. 
  • Identify, troubleshoot, and resolve issues pertaining to site monitoring and other outsourced CRO activity.
  • May conduct co-monitoring, CRO oversight visits, pre-study site 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.
  • Develop, review, and maintain trackers of enrollment, dataflow, safety and deviations among others.
  • Provide regular tracking and project update communication for Clinical Operations and executive management.
  • Perform other duties as assigned by management.

Qualifications

  • Minimum Bachelor’s Degree in a scientific field of study.
  • Minimum of 6 years clinical trial experience or relevant experience in the medical/scientific area, including demonstrated skills and competency in study management and monitoring.
  • Clinical trial experience must include lead CTM or above role for a clinical trial. Preferably more than several trials and from start-up to closeout phase.
  • 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.
  • Solid understanding of data management, manufacturing, regulatory, safety, and statistical programming to sufficiently communicate effectively with cross-functional team members.
  • Experience in TMF development and maintenance.
  • Understanding of clinical trial vendor and site contracts, invoicing, and payments.
  • Comfortable in a start-up environment. Thrives in a fast-paced, highly collaborative, multi-disciplinary team setting.
  • Ability to travel, domestically and internationally, at least 10% of the time.
  • 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.
  • Oncology, rare disease or other extremely complex clinical trial experience.
  • Project Management experience within small biotech is a plus.
  • Project Management training or certification is a plus.
  • International clinical trial management experience is a must.