Trial Master File Associate Director - Remote

Trial Master File Associate Director

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 the 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 client's success by sharing ideas openly and honestly.

Primary Purpose

Reporting to TMF Senior Director, and a member of the TMF Service Group, which supports Emmes' mission of shedding light on important human health problems through scientific partnerships that result in innovative solutions. This is accomplished by ensuring that Emmes provides the highest possible quality and efficiency of management of the TMF for Emmes' projects and its corresponding sponsors that create value for the project.

Responsibilities

• Communicates corporate goals to the TMF group and models corporate culture through vision, action, and learning.
• Provides direct supervision to TMF Managers and to TMF Specialists, who are responsible for resource management, training, quality of service to projects, and supervising the career paths of TMF staff.
• Holds direct reports and staff accountable for high performance while promoting engagement and fostering a value-based culture of accountability.
• Responsible for the management of the TMF SOP lifecycle as well as Work Instructions that accurately reflect the 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 GCPs guidance for the improvement of member performance.
• Ensures CAPA resolution for all TMF activities in a timely fashion and communicates proactively with QA representatives regarding resolutions.
• Responsible for coordinating QA process audit responses assigned to the TMF group. Identifies any risks as a result of the audits and creates a risk mitigation plan. Implements appropriate resolutions and identify any additional training needs.
• Establishes ongoing training for inclusion in Emmes U, and monthly TMF group meetings for TMF managers and TMF Specialists. Coordinates TMF training needs with the ClinOps Director of Training and Development.
• Develops appropriate training budgets and monitors for compliance with department goals.
• Ensures TMF operations job descriptions and career paths are created, maintained, and communicated to the TMF Specialists and TMF Managers.
• Creates high group engagement metrics (through Gallup and other means) across clinical operations for TMF staff.
• Identifies and tracks progress on corporate goals for TMF ClinOps group.
• Ensures timely and comprehensive performance evaluations with direct reports, and for all staff within the TMF group as well as TMF Managers.
• Presents at client kick-off meetings as well as acts as leads for the sponsor operational meetings.
• Ensures internal and external TMF identifications and project assignments meet project needs for current and future work, in collaboration with Talent Department and in conjunction with TMF Managers and TMF Specialists.
• Maintains the TMF project planning capacity tracker in coordination with the PMO group.
• Provide supervision for staff assigned to report clinical trials and their results to ClinTrials.gov, meeting all regulatory reporting requirements.
• Provides the support required to the Proposal and Pricing Department to appropriately resource and price new business opportunities for tasks within the TMF purview.
• Provides global leadership for projects using TMF staff from Canada and India and any other geographical location based on project and sponsor needs.
• Other duties as assigned

Experience

• Bachelor's degree required, preferably in a scientific discipline, Masters degree preferred
• Incumbent typically will possess at least 5-7 years of progressive clinical operations supervisory e/TMF experience within a pharmaceutical, biotechnology, or contract research organization performing clinical operations functions
• Comprehensive knowledge of GCP, GDPs, and TMF governing regulations, such as the TMF Reference Model and ICH E6 (R3).
• Experience in NIH-sponsored clinical programs is a plus.
• Excellent organizational, planning, analytical, and problem-solving skills.  Attention to detail is required.
• Prior experience with Veeva Vault Clinical Suite is required.
• Excellent verbal and written presentation and communication skills are necessary. 
• Highly motivated, results-driven with an unyielding predisposition to detail, accuracy, and clarity.
• Consistently exercises sound judgment and effectively prioritizes competing tasks in a fast-paced and dynamic environment.
• Possess a 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

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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.