Senior Director, TMF Lead

Overview

Senior Director, TMF Lead

The Emmes Company, LLC is a global 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.

Primary Purpose

The Senior Director, TMF Lead supports Emmes' mission of shedding light on important human health problems through scientific partnerships that result in innovative solutions. This is accomplished by leading the Trial Master File (TMF) Department in the delivery of high-quality, inspection-ready Trial Master Files (TMF) for projects and clients via implementation of industry best practices for TMF management.

Responsibilities

1. Responsible for TMF quality and compliance across Emmes studies. Ensures TMFs follow ICH E6 Good Clinical Practices (GCP), applicable SOPs, other regulatory requirements, and quality standards, and are delivered within expected timelines, budgets, and contractual requirements.
2. Develops and implements an industry-leading TMF strategy, including TMF metrics, continual process improvement programs, and the evaluation and adoption of new technology (e.g., AI, new eTMF software, etc).
3. Leads the global TMF team (employees and contractors) and is accountable for the global performance of staff, including staff training, staff development, resource management, and staff engagement activities.
4. Directly supports regulatory inspections and audits representing TMF; serves as a subject matter expert on TMF management, providing guidance and support to cross-functional teams, internal, and external stakeholders, as needed.
5. Oversees eTMF systems' configuration and configuration changes through established change control processes, including prioritization, implementation, data migration, training/retraining on the system, and collaboration with stakeholders.
6. Reviews, communicates, and mitigates risks/deficiencies of TMF deliverables based on performance trend analyses and metrics.
7. Leads the overall TMF department performance and addresses quality findings in collaboration with QA representatives, including CAPA, audit findings, and internal quality review findings.
8. Collaborates with other Clinical Operations and department Directors/Leaders in the implementation of new processes and continuous review of current processes/agreed process improvements within the organization. Works closely with cross-functional teams to identify knowledge gaps and developing training/interventions to address needs across the organization.
9. Supports business development in representing TMF and Emmes in new business opportunities, identifying and implementing solutions for client needs, and approves TMF proposals and budgets.
10. Communicates corporate goals to the TMF team and models corporate culture through vision, action, and learning.
11. Holds direct reports and staff accountable for high performance while promoting engagement and fostering a value-based culture of accountability.
12. Ensures regional TMF job descriptions and career paths are aligned globally, maintained, and communicated.
13. Performs other duties as assigned.

Required Attributes

Vision and Strategy

• Develops and presents a strong business case for the TMF department's strategic plan and initiatives.

• Sets objectives and key results for defined groups or functions in alignment with corporate strategy.

• Communicates and implements strategy at the operational level in defined groups or functions.

Team Building

• Leads and builds effective teams across broad groups or functions within the organization.

• Fosters collaborative relationships across broad groups or functions to ensure an integrated approach to providing services.

• Sets and holds direct reports accountable for achieving their objectives.

• Mentors the next generation of leaders.

• Leads change consistent with company objectives.

Problem Solving

• Demonstrated strong problem-solving and analytical skills, combined with business judgment.

Oversight

• Oversight of a broad group or function of the organization with responsibilities for successful operations and to deliver service or expertise internally or externally.

Metrics

• Collects, analyzes, and provides metrics to ensure delivery of services that exceed customer expectations across defined groups or functions within the organization.

Culture

• Sets the cultural tone for broad groups or functions in alignment with Emmes values and provides inspirational leadership through example rather than decree.

• Exemplifies Emmes values in all actions and behavior.

Credibility and Integrity

• Develops executive presence and the ability to establish credibility with employees and business partners, the ability to build consensus and achieve goals through influence versus direct line authority.

• Impeccable integrity as a leader and quickly seen as a role-model for leadership.

Continuous Improvement/Change Management

• Promptly takes the required corrective action when necessary.

• Continually assesses the operational effectiveness of structures in place to deliver service and reevaluates approaches and introduces innovations to change paradigms that are ineffective or outdated.

• Brings new ideas and innovative solutions where practical to drive efficiency, enhanced quality, and differentiating value to the client.

• Passion for improving human health.

Communication

• Continuously communicates up, down, and across the company to share progress and solutions and future vision.

• Listening skills that embrace cognitive diversity.

• Ability to communicate with highly scientific client-management teams.

• Stays informed and communicates to others in a supportive manner regarding corporate activities.

Supervisor Responsibilities:

• Manages and develops direct reports, helps individuals craft their career development plans, and provides on-job training opportunities for the TMF team.

• Sets clear goals and expectations for direct reports using the performance review process and holds the team accountable for performance.

• Manages and evaluates day-to-day performance of direct reports through to PIP's and terminations if required.

Qualifications

1. Bachelor's Degree and 15+ years OR master's degree and 12+ years of experience in Clinical Operations and TMF in CRO/pharmaceutical/biotechnology industry.
2. At least 5 years of experience managing a global team. Past participation in regulatory inspections.
3. Experience in developing, implementing, and measuring success in departmental strategic plans.
4. Thorough knowledge of and experience using electronic TMF application(s) for major non-proprietary system(s), TMF management metrics, and clinical trial management systems.
5. Thorough knowledge of all sections of the TMF Reference Model (CDISC).
6. Thorough knowledge of documents from various functional areas and their appropriate e/TMF filing requirements.
7. Thorough knowledge of International Council for Harmonisation (ICH), Good Clinical Practice (GCP), and Good Documentation Practice (GDP) principles.
8. Ability to work modified schedules to attend meetings with staff and clients in EU, India, and US time zones.