Manager, Trial Master File (Home-Based)

7 days left

Location
Rockville, Maryland
Salary
Competitive
Posted
Jul 23, 2022
Closes
Aug 22, 2022
Ref
3385
Function
Management
Industry
Science
Hours
Full Time
Trial Master File Manager

US Remote Worker

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.

Primary Purpose

The Manager, TMF 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:
  • 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

Provide Corporate and project-specific eTMF (Veeva Vault) support:
  • 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

Experience
  • 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
  • Strong familiarity with Veeva Vault eTMF system
  • 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


Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
  • Unlimited Approved Leave


  • Tuition Reimbursement


  • 401k & Profit Sharing Plan
  • Work From Home Anywhere in the US


  • Maternal/Paternal Leave


  • Casual Dress Code & Work Environment


CONNECT WITH US!

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Find us on LinkedIn - The Emmes Company, LLC

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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