What are the responsibilities and job description for the Clinical Documentation Specialist Consultant (6 months) position at Biomea Fusion?
Position Summary:
Biomea Fusion is hiring a Clinical Documentation Specialist who will be responsible for supporting various TMF related activities such as assisting with TMF close-out reviews and TMF transfer and archival. This role is on-site at least 3-days a week; remote employees will not be considered.
Essential Responsibilities:
- TMF Completeness Reviews
- TMF QC Reviews
- Supporting the transfer of TMFs as needed
- Supporting the archival of TMFs as needed
- Uploading documents into the TMF
- Running reports and following up with stakeholders to ensure timely resolution of any outstanding Quality Issues
- Working directly with functional area content owners as needed
Ad Hoc Responsibilities:
- Participating in Periodic TMF QC review cycles
- Participating in Completeness Checks and ensuring accuracy of the Expected Document Lists (EDLs)
- Assisting with Oversight Reviews of CRO-owned TMFs
- Supporting management with TMF activities as needed
- Participating in audits and assisting with inspection readiness activities as needed
Education and Experience Requirements:
- Bachelor’s degree from an accredited institution or equivalent practical experience of at least 3 years
- Fundamental understanding of filing systems and organization tools
- Familiarity with the CDISC Master File Reference Model structure
- Experience with Veeva Vault Clinical (eTMF) and WingSpan (eTMF) preferred
- Detail oriented
- Collaborative, team-oriented mindset with strong verbal and written communication skills
- Knowledge and understanding of GCP/ICH and CFR Regulations
- Proficiency with Microsoft Office Products - Word, Excel, Powerpoint, Sharepoint
Industry:
- Biotechnology
Employment Type:
- Consultant
Equal Employment Opportunity: At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
Compensation:
The anticipated hourly range for fully qualified candidates applying for this role is from $35.00 to $50.00 per hour.
Salary : $35 - $50
