Clinical Documents and Study Administrator
This is an exciting opportunity to work within a fast paced environment at AnaptysBio, which is a clinical-stage antibody development company advancing therapeutic antibody product candidates focused on unmet medical needs. As a Clinical Documents and Study Administrator you will be responsible for the application of metadata and quality control review of documents submitted to Trial Master Files, participate in periodic audits of the TMFs (internally and externally), and drive the resolution of issues discovered during those audits. Additionally, this role will assist the clinical development teams in ensuring the most effective and efficient conduct of clinical development studies by providing administration and project tracking support.
These may include, but are not limited to, the following; other duties may be assigned:
• Supervise the study TMF set-up: internally and externally with CRO TMF Lead.
• Drive creating, writing, approving the TMF plan acceptable to Project Study Team
• Monitor the completeness and quality of the TMF and provide metrics and TMF progress reports to the Clinical Team, organizing TMF readiness checks
• In case of compliance issues with the process or missing documents, is accountable for defining/implementing remediation plans in collaboration with the Clinical sites, CROs and Clinical team members.
• Provide support and expertise to the Clinical Trial Team members on the TMF Management.
• Lead the harmonization /improvement of TMF or Clinical Documentation processes including SOP development and revisions as necessary.
• Contribute to activities related to the maintenance or evolution of any TMF-related tool (user requirements, User acceptance testing, etc.).
• Represent the platform on committees and working groups within Clinical Development as requested
• Educate clinical teams or stakeholders on TMF processes as requested
• Provide general administrative support to the Clinical Operations Department
• Assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
• Supports the Clinical Operations teams with ongoing conduct of studies such as coordinating and tracking trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate.
• Set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
• Contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.) if requested.
• Support scheduling project team meetings and generate meeting minutes.
• Bachelor’s in related scientific/healthcare field or RN is preferred
• Very good knowledge of the clinical development process: 5 years experience in clinical research
• Very good knowledge of the TMF regulations, ICH, etc and TMF platforms.
• Strong knowledge of Essential Documents and FDA/ICH guidelines
• Experience working with ClinicalTrials.gov
• Ideally previous experience as a Records Manager or CRA.
• Fluent English communication skills, verbal and written
• Very good interpersonal skills - ability to work with individuals at different levels
• Clinical Trial Management skills including good organizational skills, ability to manage multiple tasks and meticulous attention to detail.
• Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook.
• Position may require less than 10% domestic and/or international travel