Associate Trial Manager File Specialist (Full-time or Part-time)

Emmes Services Pvt. Ltd, ("Emmes") is searching for Associate 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.

The Associate Trial Master File 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 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 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.

Key Accountabilities/Duties/Responsibilities

• Performs key Associate 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.).

• Assists with 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, as required.

• Ensures that all new and updated record information is accurately entered in the appropriate records management databases, such as RTS and eTMF Veeva Vault, 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

• Assists project staff in tracking that essential documents are received and maintained across assigned studies and sites, including interfacing directly with sites to complete all document collections and check for accuracy.

• Verifies receipt, reviews for identification and consistency, sorts, separates, photocopies, prints, scans, indexes, labels, and files a variety of clinical, TMF and other non-clinical documents, as assigned.

• Collaborates with CRAs to ensure support for the collection and tracking of documents.

• 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.

• Responsible for tasks associated with posting studies to ClinTrials.gov.

• Assists with activities for off-site archival of clinical and TMF records.

Physical Demands The physical demands of this job are that of a normal Emmes office environment.

Travel May travel between corporate locations.

Required Education and Experience

• Bachelor's degree preferred. • 1-2 years of experience in Clinical Operations.

Required Skills/Abilities

• Knowledge of clinical research concepts and able to work in a team environment.

• Excellent organizational and planning skills.

• Ability to build and maintain positive relationships with management, peers.

• Ability to access technical information and read study materials such as protocols, MOPs, and User Guides, and understand the overall purpose and objectives of the documents.

• Excellent written and verbal skills required.

• Display strong analytical and problem-solving skills.

• Applies knowledge learned from one task to the next.

• Exercises judgment within defined procedures and practices to determine appropriate action.

• Brings QC observations to the attention of 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.

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