Lead TMF Specialist

Overview:

The Emmes Company, LLC (Emmes) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our Character Achieves Results culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee from entry level through top executive to contribute to our clients success by sharing ideas openly and honestly.

Responsibilities:

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, regarding ICH Guidelines for Good Clinical Practice, Good Documentation Practices and the TMF Reference Model, as required.
Performs quality checks on junior staff's work.
Ensures that all new and updated record information is accurately entered in the appropriate records management databases, such as RTS and eTMF eeva 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.
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.
Leads project staff in tracking that essential documents are received and maintained across assigned studies and sites.
Provide support in the review of Informed Consents (ICFs) on a project-byproject basis. May share this responsibility with Regulatory Affairs depending on legacy or future contract proposals.
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.
Attends and presents at outside conferences to assure currency of knowledge and shares information learned at project or corporate role meetings.
May contribute to scientific manuscripts and presentations.
Collaborates with CRAs and CSMs to provide updates and support on an as needed basis.
Other duties as assigned

Qualifications:

Bachelor's required, preferably in scientific discipline.
Master's degree preferred.
7 years or more of experience with electronic Trial Master Files (eTMF) solutions highly preferred
Extensive 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.
Universal knowledge of clinical research concepts and able to work in a team environment.
Experience in line-management and/or 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.
Has strong capacity to synthesize information from one protocol to another on the same project. Applies knowledge learned from external meetings to improve project or corporate activities.
Works on complex problems of diverse scope in which analysis of situations or data requires an evaluation of intangible variables.