The Emmes Company, LLC ("Emmes") is searching for a TMF Manager
. 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 eight 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 TMF Manager is responsible for the overall management and operational activities for the TMF Group, which supports Emmes' mission of shedding light on important human health problems through scientific partnerships that result in innovation solutions. This is accomplished by ensuring that Emmes provides the highest possible quality and efficacy of focused monitoring to Emmes projects and its corresponding sponsors that create value to the projects. Responsibilities Essential Document Management:
Provide Corporate and project-specific eTMF (Veeva Vault) support:
- Develops, maintains, and oversees usage of standardized document descriptions for TMF components and other essential documents, including contract deliverables, generated during product development and clinical trial conduct, based on best practices and Emmes procedures and in conjunction with Subject Matter Experts
- Develops, maintains, and oversees applicable SOPs (Project and Corporate) and templates to ensure that routine document management operations are performed in adherence with ICH/GCP/regulatory guidelines and best practices
- Establishes and oversees document mapping from project team folders to archival systems, including the eTMF and other controlled electronic media, and establishing standardized document naming conventions
- Coordinates and oversees document management activities, including archiving, performed by third parties, such as vendors, clinical sites, collaborators, as well as other internal and external team members, as required
- Acts as an administrator of the Veeva Vault eTMF system, setting up and maintaining the system in conjunction with the Clinical Systems Manager
- Establishes and maintains company guidelines and work instructions for eTMF (e.g., TMF set-up, quality management, reports and metrics, TMF quality control (QC)/ quality assurance (QA) activities, etc.)
- Leads user training (internal and external) and train-the-trainer training sessions, establishing and maintaining user reference materials for all user types and tracking trained users, user access and eTMF permissions
- Collaborates with the Associate Director and Proposal Manager to create timelines and budgets for eTMF deployment, ensuring project resources are utilized appropriately given their site activation / close-out processes
- Oversees and supports eTMF implementation at the corporate and project levels, establishing user roles and cross-functional governance to ensure optimal utilization. Assists with optimal eTMF utilization and close out by assisting with the drafting and maintenance of paper to eTMF mapping documents responding to questions, advising on document placement, and troubleshooting as needed
- Collaborates with the SOP Manager to develop and maintain eTMF and TMF SOPs and templates according to the TMF reference model
- Ensures optimal use of eTMF functionality by analyzing project and industry best practices and transferring manual processes into automated workflows, as possible
- 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 contact proposals
CONNECT WITH US!!
- Bachelor's degree required, preferably in a scientific discipline
- Master of Science preferred
- Incumbent typically will possess 3-5 years of Clinical Operations experience and at least 3-5 years with lead or supervisory experience
- Thorough knowledge of GCP and TMF governing regulations, such as the TMF Reference Model required
- Prior experience managing staff and/or in a mentorship role required
- Experience in NIH-sponsored clinical programs is a plus
- Strategic thinking, leadership skills, assertiveness, strong technical background, good business judgment, integrity, and excellent negotiation and project management skills as evidenced by past performance within a clinical operations group
- Excellent organizational, planning, analytical, and problem-solving skills. Attention to detail required.
- Ability to build and maintain positive relationships with management, peers, and subordinates
- Excellent verbal and written presentation and communication skills are necessary. Highly motivated, results driven with unyielding predisposition to detail, accuracy and clarity
- Consistently exercises sound judgement and effectively prioritizes competing tasks in a fast-paced and dynamic environment
- Demonstrate increasing levels of trial management responsibilities
- Experience with study start up, timeline planning and management and financial management of clinical trials including vendor oversight required
- Possess high degree of initiative and the ability to work independently
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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.