Summary of the Position:
The TMF Specialist I is responsible to deliver controlled and quality trial master file documents for the purposes of regulatory and health authority inspections; and to ensure compliance as delegated by trial sponsors and under applicable institutional policy.
Essential Functions:
- Responsible for paper Trial Master File (TMF) set-up, maintenance, update, archival and destruction (if applicable) in accordance with FHI Clinical processes, Sponsor requirements, and applicable regulations.
- Responsible for comprehensive review and approval of TMF/eTMF Management plans.
- Responsible for assessing training needs of staff regarding TMF/eTMF document delivery and implementing training (individual and/or departmental).
- Responsible for maintaining systems and tools for evaluating, tracking, and transmitting trial master file documents.
- Ensure adequate set-up of master files including proper and timely filing of all relevant study documents.
- Maintain documents master files according to regulatory and company-defined standards.
- Conduct detailed and appropriate quality checks on TMF/eTMF documents at defined timepoints, including any paper originals required.
- Conduct TMF/eTMF content reviews and provide TMF/eTMF content reports on a regular basis.
- Ensure that FHI Clinical privacy and security standards are met and adhered to. Ensure that documents are maintained in accordance with FHI Clinical retention practices.
- Assist in routine internal and external master file audits to ensure compliance with applicable work instructions, Standard Operating Procedures (SOPs), Policy & Procedures, FDA and ICH GCP guidelines.
- Participate in organizational process improvements as required.
- Assists with maintaining up-to-date study status tracking and other tracking tools (as assigned)
Knowledge, Skills and Abilities:
- Ability to work well with people and establish effective relationships across all levels of the organization.
- Strong computer skills (MS Office), SharePoint, and Acrobat.
- Ability to format and publish large documents and create and maintain tracking systems and spreadsheets.
- Ability to coordinate review and finalization of documents with multiple stakeholders. Aptitude to learn additional software programs and databases quickly.
- Ability to handle multiple tasks simultaneously; manage and prioritize workload in a proactive manner.
- Ability to work effectively under pressure of deadlines.
- Demonstrated ability to make decisions involving conflicts of interest.
- Excellent attention to detail.
- Knowledge of clinical trial design, execution, and operations.
- Must be able to read, write and speak fluent English
Position Requirements:
- Education: High school diploma required.
- Preferred Job-related Experience: 1-3 Years of documentation management and experience with FDA, ICH, and GCP guidelines. Experience with managing clinical study documents using FDA, ICH GCP guidelines and best practices pertaining to clinical trial document management and archiving. Prior experience working in a cross-matrix environment. Experience with clinical study electronic databases.
- Additional Eligibility Qualifications: Technology to be used: Personal Computer, e-mail, telephone, printer, calculator, copier, cell phones, and other handheld devices. Strong computer skills (MS Office), SharePoint, Acrobat and ability to work in FHI360databases.Ability to format and publish large documents and create and maintain tracking systems and spreadsheets. Ability to coordinate review and finalization of documents with multiple stakeholders
Physical Expectations:
- Typical office environment.
- Ability to sit or stand for extended periods of time.
- Ability to move 5-50 lbs
Travel Requirements:
The expected travel time is less than 10 % for this position.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.
FHI Clinical, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.
This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.
FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.
FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.
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More Information
- Job City Centurion, South Africa
