Clinical Compliance Operations Manager

2 months ago


Remote, United States Beacon Hill Life Sciences - Boston Full time
Job DescriptionJob Description
  • Track and monitor progress of department action items related to inspection readiness activities
  • Contribute to activities related to department standardization of execution with Clinical Research Organization (CRO) partner(s)
  • Generate, review and share various Key Performance Indicators (KPIs), Key Quality Indicators (KQIs) and other metrics e with key department members
  • Assist with system access management activities for electronic Trial Master File (eTMF) system
  • Assist with identifying potential process gaps and opportunities for improved efficiencies and risk mitigations
  • Track the creation of new or revisions of existing controlled documents (e.g., SOP, Work Instructions)
  • Assist with eTMF report generation and conducting TMF completeness activities
  • Assess potential process updates based on ICH E6, r3 updates
  • Other department tasks, as needed

Requirements

  • BS/BA degreed discipline and 3 years of related experience
  • Knowledge of TMF-related activities, including CDISC-TMF Reference Model
  • Knowledge of the drug development process including Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) requirements
  • Understanding of the clinical trial stages, such as study start-up, maintenance, and closeout
  • Experience with a growing biotechnology company
  • Ability to work independently and collaboratively with internal teams in a fast-paced, multi-disciplinary team environment
  • Solid communication skills
  • Proficient in the use of the Microsoft Office Suite
  • Experience with PhlexTMF and Veeva QMS a plus

 

Company DescriptionBeacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/

Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.Company DescriptionBeacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.\r
\r
If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/\r
\r
Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

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