Trial Master File (TMF) Director

The Emmes Company, LLC (“Emmes”) is searching for a Trial Master File (TMF) Director located in our Rockville, Maryland, or Frederick, Maryland office.

Emmes provides flexibility for office location preference, dependent upon position.

Emmes is a Contract Research Organization (CRO).

Headquartered in Rockville, Maryland, Emmes employs over seven hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, 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 Director supports Emmes’ mission of shedding light on important human health problems through scientific partnerships that result in innovative solutions.

This is accomplished by successfully leading the TMF group to ensure that Emmes provides the highest possible quality and efficiency of focused monitoring to Emmes’ projects and its corresponding sponsors that create value to the projects.

Responsibilities Communicates corporate goals to the TMF group and models corporate culture through vision, action, and learning Provides direct supervision to TMF Associate Directors, Clinical Systems Manager, and SOP/Training Manager who are responsible for providing the support of the infrastructure of the TMF group Attends TRU monthly meetings Holds direct reports and staff accountable for high performance while promoting engagement and fostering a value-based culture of accountability Responsible for overseeing the creation and maintenance of TMF SOPs and Work Instructions that accurately reflect the standards of activities falling under the responsibilities of TMFs.

Will work to ensure cross collaboration with the other ClinOps verticals to maintain consistency Promotes quality standards and adherence to regulations and ICH guidance’s for improvement of member performance Ensures CAPA resolution for all TMF activities in a timely fashion and communicating proactively with QA representatives regarding ongoing resolution activities Establishes internal and external training standards and manages the training budget Ensures TMF operations job descriptions and career paths are created, maintained, and communicated to the TMF members through the Managers Creates high group engagement metrics (through Gallup and other means) across clinical operations for TMF staff Identifies and tracks OKRs for TMF ClinOps group Ensures timely and comprehensive performance evaluations with direct reports, and for all staff within the TMF group in conjunction with their TMF Managers and the associate directors Ensures internal and external TMF identification and Project assignments meet project needs for current and future work, in collaboration with Talent Department and in conjunction with TMF Managers Provides the support required to the Proposal and Pricing Department to appropriately resource and price new business opportunities for tasks within the TMF purview Experience Bachelor’s degree, preferably in a scientific discipline, with at least 10 years of experience within pharma and/or CRO Thorough knowledge of electronic TMF application(s), for major non-proprietary system(s) and ability to prioritize related tasks based on project goals Thorough knowledge of all sections of the DIA Reference Model (current version) Thorough knowledge of documents from various functional areas and their appropriate e/TMF filing requirements Thorough knowledge of International Council for Harmonisation (ICH) Good Clinical Practice (GCP) as well as Good Documentation Practice (GDP) principles Time spent directly in a medical environment (e.g.

as a Study Site Coordinator) is also considered relevant Participates in and directs activities related to department staff operations such as interviewing and selection, professional development, training, performance management, and employee counseling and separations Prior supervisory experience is required Management level expertise required, including history of providing strategic oversight of vision and execution for a large, complex team Proven history of leading and building effective teams across broad groups or functions within the organization; demonstrated team player with a work history of interacting with others respectfully and cordially Professional maturity and wisdom to work through challenges in an expedient manner and push through issues to reach mutual outcomes across teams Demonstrated strong problem solving and analytical skills, combined with sound business judgment Proven ability to effectively collect, analyze, and provide metrics to ensure delivery of services that exceed customer expectations across defined groups or functions within the organization Knowledge of directing recruitment, hiring, supervision, coaching and evaluation of staff.

Ability to work proactively and effectively, with creative problem-solving skills Demonstrated leadership skills and ability to effectively interface with executives Highly motivated with ability to work independently and as part of a multi-disciplinary team Strong project management and time management skills 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.