MedFocus Clinical Document Mgmt Spec IV in United States

Job Description: Reporting to the Data Management Team Lead, and working in collaboration with the clinical study Data Management Leads, the Clinical Document Management Specialist (CDMS) is responsible for assisting the Lead Data Managers with the management and oversight of Trial Master File (TMF) records.

Focusing on inspection readiness, supports preparation of documentation required for regulatory agency inspections and internal audits including loading study documentation into the sponsor's electronic trial master file system according to the TMF roadmap. May be required to scan or to arrange for scanning of paper TMF to convert to electronic format or to obtain electronic copies of documents from CRO providers as directed by the Lead Data Managers.

Minimum requirements:

  • Associates/Bachelor’s degree or equivalent preferred

  • Minimum 2 years of pharmaceutical industry experience

  • Records management/TMF experience

  • Familiarity with various aspects of clinical trials and regulatory submissions. Current awareness of regulatory requirements for clinical trials (ICH/GCP).

  • Sufficient knowledge of regulatory requirements and ICH-GCP guidelines to support records management

  • Demonstrated ability to work independently, take initiative, complete tasks to deadlines

  • Requires strong attention to detail, document organization skills

  • Previous experience with Data Management Documentation in a Data Management role is highly desirable.

  • Experience with use of Electronic Document Management Systems and electronic learning systems.

  • Advanced computer proficiency

Min Salary: $0.00

Max Salary: $0.00

State: MA