Clinical Trial Manager

Clinical Waltham, Massachusetts


Description

Position Summary:

The Clinical Trial Manager is accountable for the management of clinical trial activities including monitoring oversight and ensuring accurate data and document collection. The CTM proactively identifies, resolves/mitigates and escalates risks and/or issues and may be responsible for clinical trial activities for multiple studies.

Responsibilities:

  • Ensure trial adherence to ICH/GCP/local regulations.
  • Assisting with the development of high-quality monitoring report templates and plans
  • Ensure country and site selection meet study requirements.
  • Reviewing monitoring reports and escalating monitoring and/or data integrity issues as appropriate
  • Ensure accuracy and timeliness of vendor and site payments.
  • Ensuring the validity, correctness, and completeness of clinical data reviewed and collected as dictated by study plans and the protocol
  • Ensure availability of clinical/non-clinical supplies.
  • Provide input for clinical trial plans and documents as required
  • Ensure internal and external systems are updated in a timely manner (CTMS, clinicaltrials.gov).
  • Maintain and oversee the Trial Master File.
  • Identify, address, and communicate quality and compliance concerns.
  • Ensure inspection readiness internally and externally.
  • Provides regular study activity status updates as requested.
  • Communicate effectively with internal and external study personnel (investigative site staff, monitors, Project Managers).
  • Other duties and responsibilities as required.

Qualifications:

  • Bachelor’s Degree required.
  • Experience in rare disease or ophthalmology not required but preferred.
  • 2+ years’ experience working in a biotech, pharmaceutical or medical device environment.
  • Study management experience is a plus.

Skills, Knowledge & Abilities:

  • Excellent verbal and written communication skills.
  • Experience in a start-up environment preferred.
  • Must be pro-active team player, flexible, and open to change.
  • Knowledge of GCP and ICH.
  • Experience developing monitoring plans and report templates
  • Experience in multiple phases of research preferred.
Other:

Applicants must be authorized to work in the U.S.

Apellis is…

A clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.