Regulatory eTMF & Publishing Specialist
The EMMES Corporation, established in 1977, is a privately-owned Contract Research Organization (CRO). Headquartered in Rockville, Maryland Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.
Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We provide statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.
The Regulatory eTMF & Publishing Specialist is responsible for the overall management and quality maintenance of essential clinical trial and other designated documents, including the set up and maintenance of the Trial Master File (TMF), with a strong focus on ensuring that routine document management operations are performed with adherence with SOPs (Project and Corporate) and ICH/GCP/regulatory guidelines. This position plays a key role in both paper and electronic TMF system management, by filing, organizing and maintaining paper and/or digital records and coordinating the document management activities performed by third parties, such as vendors, clinical sites, collaborators, as well as other internal and external team members, as required.
This position will where needed perform publishing of other regulatory documents in the eCTD format. This will involve tasks such as hypertext linking, bookmarking, converting documents to PDF, and submitting to agencies via the FDA’s electronic gateway.
Performs key TMF system administrator role and duties in accordance with the company guidelines and work instructions (e.g., TMF set-up, quality management, reports and metrics, TMF quality control (QC)/ quality assurance (QA) activities, etc.)
Accountable for the overall TMF quality and completion, including appropriate document filing and maintenance, cross-functional document coordination, including third party documents and TMF tracking and reporting to internal and external customers
Ensures the TMF file structure follows applicable company approved TMF configuration, with reference to ICH Guidelines for Good Clinical Practice, Good Documentation Practices and the DIA TMF Reference Model, as required
Ensures that all new and updated record information is accurately entered in the appropriate records management databases, such as TMF, for inspection readiness and highest quality of document governance
Ensures that all assigned records are maintained in accordance with the company eTMF and/or other electronic data room storage SOPs, processes and data structure
Performs advanced searches and develops routine and complex management reports and metrics, as requested
Assists project staff in tracking that essential documents are received and maintained across assigned studies and sites
Verifies receipt, reviews for identification and consistency, sorts, separates, photocopies, prints, scans, indexes, labels, and files a variety of clinical, regulatory and other non-clinical documents, as assigned
Ensures customer requests for retrieval, reproduction, and re-filing of requested records or electronic images (e.g. PDF, jpeg) are met in a timely manner
Manages activities for off-site archival of clinical and regulatory records
Actively participates and may lead vendor evaluation and selection process (e.g., Off-site Storage, Printing, etc.)
Represent Regulatory Document Management at team meetings, may lead teams and participates in collaborative efforts and plays an important cross-functional role, cross-department role in records and document management
Develops and maintains company’s digital records/TMF training materials and guidelines and performs training and/or coaching of new and existing staff as required
May supervise and/or mentor less experienced Regulatory Document Specialist personnel
Participates on department teams or task forces to improve company’s processes and procedures
Participates on department teams or task forces to establish publishing timelines
Prepare regulatory documents in the eCTD format
Prepare documents for publishing by creating external hypertext links, bookmarks, and convert documents to PDF
Bachelor’s degree from a university is preferred; however, the combination of experience and training will be taken under consideration
Minimum 3 years’ industry experience with 3 years’ relevant document management experience (e.g, Records Information Management, library sciences, etc.)
1 year or more of experience with electronic Trial Master Files (eTMF) solutions highly preferred
Working knowledge of Good Clinical Practices (GCP) and TMF governing regulations, such as DIA Reference Model
Thorough understanding of records management requirements in Drug Development
Experience with coordinating document management activities performed by third parties, such as clinical vendors
Prior publishing experience preferred
Experience with publishing tools preferred
Knowledge of clinical research concepts and able to work in a team environment
Experience in line-management and/or mentoring less experienced staff
Excellent organizational and planning skills
Ability to build and maintain positive relationships with management, peers, and subordinates
Excellent written and verbal skills required
Display strong analytical and problem solving skills
Attention to detail required
Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs
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The EMMES Corporation is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.