Senior TMF Specialist

Senior Trial Master File Specialist



Emmes Services Pvt. Ltd , ("Emmes") is searching for Senior Trial Master File Specialist in Clinical Research located in our Bangalore, India office. Emmes provides flexibility for office location preference, dependent upon position.

EMMES Services Pvt. Ltd, Bangalore, a fully owned subsidiary of The Emmes Company, LLC. Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over seven hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, 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 are dedicated to providing 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.

Primary Purpose

The Senior Trial Master File (TMF) Specialist is responsible for the overall management, quality, and maintenance of essential clinical trial and other designated documents, including the set up and maintenance of the TMF, with a strong focus on ensuring that routine document management operations are performed with adherence with SOPs (Project and Corporate) and ICH/GCP/TMF guidelines. This position plays a key role in both paper and electronic global 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.



Responsibilities

· Performs key Senior TMF Specialist 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, regarding ICH Guidelines for Good Clinical Practice, Good Documentation Practices and the TMF Reference Model

· Ensures that all new and updated record information is accurately entered in the appropriate records management databases and is maintained in accordance with the company eTMF and/or other electronic data room storage SOPs, processes, and data structure for inspection readiness under minimal supervision

· Ensures customer requests for TMF retrieval, reproduction, and re-filing of requested records or electronic images (e.g. PDF, jpeg) are met in a timely manner

· SME for project staff on TMF related questions; determines methods and procedures for new assignments and provides guidance or supervision to other personnel and subcontractors, including the oversight of day-to-day activities

· Performs quality checks on junior staff's work and provides re-training to the project team, as necessary

· Classify and add metadata to uploaded documents (Site Level docs uploaded by iCRA; Country level docs uploaded by SME, and Study/Trial level docs uploaded by SME); may upload documents as required

· QC review and approve documents to ensure that all new and updated documents are accurately entered in the appropriate records management databases for inspection readiness

· Leads project staff in tracking that essential documents are received and maintained across assigned studies and sites under minimal supervision

· 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 under minimal supervision

· Runs project specific metrics, identifies risks, escalates non-compliance, and provides regular feedback to project teams including actionable metrics

Provides project specific Veeva training for internal and external collaborators

· Manages activities for transfer, delivery and, off-site archival of TMF records as required by Sponsor

· May lead audit/inspection preparation with minimal supervision and participate in audits/inspections as required

· Leads review of project TMF Plans, Filing Guidance, Work Instructions, and company SOPs; suggests changes in project or corporate activities as appropriate and implements changes, as needed

· May assist in site activation and maintenance activities, including collecting and reviewing essential documents from clinical sites and provide guidance on document requirements as TMF SME

· Collaborates with project team to ensure all appropriate documents have been filed prior to specific study milestones (e.g., site activation, amendments, close-out and TMF delivery)

· May be responsible for tasks associated with posting studies to ClinicalTrials.gov

· Other duties as assigned

Experience



· Bachelor's degree required, preferably in scientific discipline

· Master's degree preferred

· 3-5 years or more of experience with electronic Trial Master Files (eTMF)solutions highly preferred

· Experience working with Veeva Vault is a mandate

· Experience with coordinating document management activities performed by third parties, such as clinical vendors

· Experience in mentoring less experienced Trial Master File staff.

· Extensive knowledge of clinical research concepts and able to work in a team environment

· Awareness of Good Clinical Practices (GCP) and TMF governing regulations, such as TMF Reference Model

· Broad understanding of records management requirements in Drug Development

· Ability to access technical information and read study materials such as protocols, MOPs, and User Guides critically and identify areas of inconsistency and other quality issues and make recommendations for improvement

· Ability to build and maintain positive relationships with management, peers, and subordinates and able to work in a team environment

· Excellent organizational and planning skills, including strong attention to detail

· Excellent written and verbal skills required

· Display strong analytical and problem-solving skills

· Strong capacity to synthesize information from one protocol/ technical task to another on the same project

· Mentor and role model for new personnel and may be involved in interviewing potential project staff



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The Emmes Company, LLC 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.