Remote Clinical Documentation & TMF Specialist

Spectraforce Technologies; Raleigh (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Spectraforce Technologies is seeking a Clinical Studies Specialist for a 100% remote, two-year assignment focusing on TMF/clinical documentation management. You will ensure real-time inspection readiness, manage eTMF artifacts, and support transfer from CROs.

The role requires a Bachelor's degree or international equivalent and at least 4 years of relevant experience; 6 years if no BS. You will collaborate with cross-functional teams, generate metrics, and participate in inspections.

Qualifications

• Bachelor's degree or international equivalent preferred.
• Minimum 4 years relevant industry experience in clinical document management or equivalent.
• If no BS, a total of 6 years professional clinical research relevant work experience.
• Proven analytical and critical thinking skills.
• Proficient knowledge of clinical documentation business procedures and compliant processes.
• Capable of working autonomously with limited oversight.
• Proven oral and written communication skills; ability to facilitate cross-functional team meetings.

Responsibilities

• Performs key operational activities across the Clinical Documentation Center for master files through life cycle.
• Collaborates with Master File Owners to support inspection readiness of clinical documentation / master files.
• May be aligned by Therapeutic Area but expected to work across all areas of the organization.
• Applies critical thinking to ensure real-time inspection readiness of clinical documentation by investigating and proactively resolving issues.
• Runs and performs review of reports and dashboards within eTMF; produces eTMF metrics.

Skills

Analytical thinking

Autonomy

Communication skills

Education

Bachelor's degree or international equivalent

Job description

Spectraforce Technologies is seeking a Clinical Studies Specialist for a 100% remote, two-year assignment focusing on TMF/clinical documentation management. You will ensure real-time inspection readiness, manage eTMF artifacts, and support transfer from CROs.

The role requires a Bachelor's degree or international equivalent and at least 4 years of relevant experience; 6 years if no BS. You will collaborate with cross-functional teams, generate metrics, and participate in inspections.