TMF Manager
Company: The Emmes Company, LLC
Location: Rockville
Posted on: February 22, 2021
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Job Description:
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: *
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 * 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 CONNECT WITH US!! Follow us on Twitter - @EmmesCRO
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.
Keywords: The Emmes Company, LLC, Rockville , TMF Manager, Executive , Rockville, Maryland
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