Clinical Operations Manager

Job Description

Lumen is seeking a highly motivated, experienced, independent manager in clinical operations to join our fast-growing organization.  This key position will oversee clinical trials (pre-IND through Phase 1-4) and will help manage our clinical development program(s).

Essential Duties and Responsibilities 

The major tasks for this position are as follows:

  • Assisting with the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial execution
  • Interface with CROs and clinical site Investigators and staff to ensure optimal site relationships
  • Participate in clinical operations, including study management, site selection, budgets and timelines
  • Supervise data management, safety management, and study project plans
  • Assist with development/development or review externally developed clinical study protocols, informed consent forms, clinical study reports and other clinical documents
  • Assist with preparation of pre-IND, IND, BLA and other regulatory filings
  • Serve as monitor or co-monitor for studies, if needed
  • Plan and participate in site selection, site initiation visits, study meetings, and vendor meetings, as needed

Desired Qualifications and Requirements 

Education and Experience Required:

  • Bachelor’s degree in a scientific or healthcare discipline required; Masters preferred
  • Clinical Research Professional Certification (ACRP/SOCRA or equivalent) helpful
  • Minimum of 6 years of experience in clinical drug development in the pharmaceutical/biotech industry 
    • At least 2 years of early-phase clinical drug development required, and
    • At least 2 years of direct study management work preferred
  • Experience in the oversight of all operational aspects of clinical studies
  • Experience conducting/managing clinical trials, CROs, multiple vendors, budgets, and timelines
  • Experience monitoring clinical studies and conducting site visits, including Site Initiation Visits etc.
  • Experience writing clinical protocols, ICF, and CSR required Experience in oncology and biologics preferred Experience leading a team of collaborative clinical professionals

The successful candidate will have the following attributes:

  • Strong leadership skills and self-awareness, with proactive and positive management approach
  • Excellent oral, written, and medical communication skills 
  • Ability to thrive in a fast-paced and entrepreneurial environment
  • Ability to function at a high level in a team setting whether leading projects or contributing independently
  • Flexibility to adapt to changing needs in real time
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Strong attention to detail and organizational skills
  • High integrity and ethics
  • Commitment to quality and timely delivery of results

Physical Requirements

  • Sit for extended periods of time (2 or more hours)
  • Occasionally lift or carry up to 20 kg

Application Instructions 

Please submit a resume and cover letter to with the job title in the subject line.

This position is available immediately. Applications will be reviewed upon receipt. Only successful applicants will be contacted.