Clinical Trial Manager

BACK

Rain Therapeutics is committed to building a passionate team of core business leaders to execute on our vision to identify, and execute on the development, of novel therapeutic avenues for the treatment of cancer.  The personality of Rain will always be focused on entrepreneurs with autonomy to build their respective teams in a flat organizational structure.

Summary:

Responsible for supporting the clinical trial management team with the implementation and conduct of clinical trials, focusing on the areas of trial planning, enrollment, site monitoring, data quality, and study reporting for Rain’s programs, beginning with tarloxotinib (Tarlox) in a Phase 2 trial for patients with EGFR / HER Exon 20 insertion mutations in non-small cell lung cancer (NSCLC). Responsibilities include implementing trial set-up, execution, oversight and reporting for clinical studies while ensuring the trials are conducted in compliance with the protocol, ICH/GCP, and applicable regulatory requirements. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The position will report to the Vice President of Clinical Operations.

Critical Job Skills:

  • Manages the operational aspects of clinical trials
  • Participates in protocol, CRF development, Clinical Study Report preparation, as appropriate
  • Prepares metrics and updates for management, as assigned
  • Proactively identifies potential study issues/risks and recommends/implements solutions
  • Participates in and facilitates CRO/vendor selection process for outsourced activities
  • Manages CRO interactions, including sponsor oversight of operational function activities (e.g., study management, monitoring, site management, trial master files)
  • May work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
  • Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Study Manuals, and CRF-Completion Guidelines)
  • Reviews site study documents for accuracy and completeness (e.g., informed consent template, study tools/worksheets, monitoring visit reports and letters, data listings, etc.)
  • Recommends and implements innovative process ideas to impact clinical trials management
  • Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
  • Participates in the development, review and implementation of departmental SOPs and processes
  • May be assigned other projects and duties as required

Preferred Education and Experience:

  • At least 5+ years of clinical trial management experience in the pharmaceutical or biotechnology industry
  • Bachelor’s Degree, Master’s Degree or higher in science, nursing, medical field, or business management
  • Experience in oncology-focused drug development organization is desired
  • Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring
  • Knowledge of FDA Regulations, ICH Guidelines, and GCP governing the conduct of clinical trials
  • Management of international clinical studies preferred
  • Experience managing vendors, including performance assessments and total financial management (invoice review, change order management, budget reforecasting, etc.)
  • Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
  • Perform initial review of CRO and other third-party study vendor invoices to ensure that work is performed in accordance with scope of work
  • Requires proven project management skills and study leadership ability
  • Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks
  • Work without close supervision both independently and as part of a team
  • Ability to multi-task and shift priorities quickly
  • Able to solve problems under pressure
  • Travel domestically and internationally as required to carry out responsibilities.
  • Must have excellent interpersonal, written and verbal communication skills
  • Strong computer experience and demonstrated proficiency in MS Office (Outlook, G-Suite, MS Word, Excel, PowerPoint)