Clinical Trial Manager (CTM)

 

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.  If this sounds like you, keep reading!

 

Role Summary

We are seeking a Clinical Trial Manager (CTM) to join the Clinical Operations team. In this role you will be accountable for the operational management and execution of global clinical trial programs (Phases I-III). The individual will be responsible for ensuring adherence to Good Clinical Practices (GCP), SOPs, and all regulatory agency guidelines, as well as study operational planning and execution. A key focus will be the oversight of and partnership with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that the quality of data is suitable for regulatory submission/inspections. The CTM will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries.

Key Responsibilities

• Oversee study scope, quality, timelines, and budget with the internal functional leads, CRO, and vendors to ensure overall project objectives are met
• Initiate and build strong relationships with key opinion leaders and clinical site staff
• Partner with the CRO to ensure robust patient enrolment strategies are developed and effectively implemented, on time and within budget
• Partner with the CRO to ensure robust ongoing data monitoring strategies are developed and effectively implemented to ensure delivery of high-quality data
• Proactively identify and manage study related risks
• Develop and manage clinical trial documents, including but not limited to protocols, Case Report Forms (CRFs), consent documents, and confidentiality agreements
• Review and manage study related plans and processes, including Investigator agreements (CTA), CRFs, CRF guidelines, monitoring plan, data management plan, Trial Master File (TMF) plan, protocol deviation management plan, and safety monitoring plan
• Review CRO and vendor contracts/work orders and specifications to align with study objectives
• Review and approve essential document packages to enable timely site activation
• Work closely with Apogee CRA team in the following areas to ensure sites within respective regions are committed to quality and patients’ safety as well as meeting enrolment expectations. Duties include, but are not limited to:   
  • Understand site issues, protocol deviations, noncompliance, and items raised in the monitoring visit reports​
  • Review of monitoring and oversight trip reports
  • Periodic visits to clinical sites to build relationships
  • Direct investigator performance and adherence to protocol, and proactively address conduct issues and enrollment problems, as necessary
• Oversee the TMF maintenance for inspection readiness, and ensure completeness at the end of the study
• Perform periodic QC of the TMF
• Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
• Ensure the study is always “inspection ready”
• Oversee and coach the functional activities of Clinical Trial Associates assigned to the project

Ideal Candidate

• Bachelor’s degree in life science or equivalent
• 5+ years of clinical project management experience in Immunology & Inflammation or Gastrointestinal therapeutic areas
• Must have experience conducting international clinical trials in a sponsor Pharma/Biotech organization
• Prior phase II and III experience