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At Goldfinch, we are pioneering a new approach to discover and develop precision medicines for kidney disease. Where others see risk, we see opportunity to make an impact and redefine the standard of care for patients with kidney disease. We recognize the importance of collaboration, and strive to work alongside people with kidney diseases, their families and clinicians to develop innovative kidney disease treatments for conditions where no approved therapies exist.

We’re looking for teammates who relish the challenge, and are compelled to leave a positive mark on the lives of colleagues and the patients we serve alike. If this sounds like the community you want to grow with, we invite you to explore our current career opportunities below.

Sr./Clinical Trial Manager Toggle

Job Summary

The Sr./CTM will be responsible for successfully executing and delivering clinical trials of an excellent quality standard and for all aspects of daily study management, from protocol design, study setup, vendor management and data cleaning through to CSR generation. The Sr./CTM ensures completion of study deliverables and proactively identifies and resolves clinical study issues while communicating effectively across the study team and executive management. This role will provide operational management and leadership of assigned clinical trials in Goldfinch Bio’s expanding portfolio of kidney-focused therapies as part of a cross-functional team. The applicant must have a thorough knowledge of FDA requirements and ICH/GCP.

Job Responsibilities

The primary responsibility of the Sr./CTM will be to execute studies in a rare disease setting to a high standard with minimal oversight. Key responsibilities will include:

  • Manage selected vendors (e.g., CROs, central labs, biomarker and specialty laboratories, recruitment vendors, clinical drug supply vendors, and investigational study sites), ensuring contracts, performance and budget are in alignment with expectations. 
  • Develop and monitor key performance indicators, escalating issues as necessary.
  • Manage study timelines proactively identifying gaps, risks, and mitigation strategies to avoid significant delays.
  • Develop and manage key study oversight documents and plans including CRO/vendor oversight plans, risk/mitigation strategies, and periodic data quality reviews.
  • Prepare key study documents including study manuals, laboratory documents, template informed consent forms and training materials.
  • Oversee development of study systems (i.e. IRT, EDC).
  • Plan, execute, and lead study-specific meetings, preparing and presenting study updates as required.
  • Work effectively with cross-functional team members, ensuring deliverables and major milestone are met.
  • Collaborate in managing Site/Investigator relationships; serving as a liaison and resource.
  • Identify potential study issues, proactively recommending and implementing solutions or corrective actions, as needed.
  • Perform internal tracking and reconciliation of clinical data, sample collection, lab results, IMP, and other clinical supplies as necessary.
  • Provide guidance to CRO team, study monitors and investigative study sites to ensure consistency in interpretation of the protocol and study procedures.
  • Ensure maintenance/oversight of the TMF and associated files.
  • Support departmental objectives and assist in the development of departmental standards and procedures.
  • Provide study-specific training and oversight to internal clinical operations staff and other contract personnel.

Required Skills & Qualifications

  • A Bachelor's degree (or higher) in a clinical or scientific field 
  • At least 4-7 years of experience working on clinical trials within the pharmaceutical and/or biotechnology industry, with at least 2 years’ experience as a CTM or equivalent.
  • Prior experience managing contracted resources/CRO required.
  • Site monitoring and clinical data review experience highly preferred.
  • Experience working in rare disease indications preferred.
  • Ability to thrive in a rapidly paced environment within fixed, hard deadlines.
  • Expertise in planning and executing study protocol and strategies.
  • Basic understanding of scientific principles and methodology.
  • Advanced knowledge of GCP and current knowledge of CFR for IND clinical trials.
  • Outstanding communication, organizational, prioritization, problem-solving, conflict resolution, leadership and team-building skills required.