Senior TMF Specialist

Location
Rockville, Maryland
Salary
Competitive
Posted
Sep 15, 2020
Closes
Oct 03, 2020
Ref
2551
Function
Other
Industry
Science
Hours
Full Time
The Emmes Company, LLC ("Emmes") is searching for a Senior TMF Specialist based out of our Rockville, Maryland or Frederick, Maryland offices. Emmes provides flexibility for the office location or work remote preference dependent upon position.

Emmes is a 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 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 Trial Master File Senior 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.

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
  • Provide support in the review of Informed Consents (ICF) on a project-by- project basis. May share this responsibility with Regulatory Affairs depending on legacy or future contract proposals
  • 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
  • Will assist in the reviewing of junior specialist's work
  • 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
  • Responsible for tasks associated with posting studies to ClinTrials.gov
  • 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
  • Leads project staff in tracking that essential documents are received and maintained across assigned studies and sites under minimal supervision
  • 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
  • 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 TMF records
  • May assist in the review of functional area SOPs and suggests changes in project or corporate activities as appropriate. Implements SOP revisions as appropriate
  • As a project or technical lead, 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
  • Collaborates with CRAs to ensure support for the collection and tracking of documents
  • Other duties as assigned.

Experience
  • Bachelor's degree required, preferably in scientific discipline
  • Master's degree preferred
  • Minimum 3-5 years or more of experience with electronic Trial Master Files (eTMF) solutions highly preferred
  • Awareness of Good Clinical Practices (GCP) and TMF governing regulations, such as DIA Reference Model
  • Broad understanding of records management requirements in Drug Development
  • Experience with coordinating document management activities performed by third parties, such as clinical vendors
  • Extensive knowledge of clinical research concepts and able to work in a team environment
  • Experience in mentoring less experienced Trial Master File 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
  • Is a staff mentor and role model for new personnel and may be involved in interviewing potential project staff
  • Has strong capacity to synthesize information from one protocol/ technical task to another on the same project.


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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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