Senior Director, TMF

4 weeks ago

Ahmedabad, Gujarat, India Emmes Full time

Overview

Senior Director, TMF (Trial Master File)

India Remote/Ahmedabad/Bengaluru/New Delhi

Emmes is a global Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. Our culture is driven by five key values: 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.

Primary Purpose

The Senior Director, TMF supports Emmes' mission by leading the Trial Master File (TMF) Department in delivering high-quality, inspection-ready TMFs for projects and clients via implementation of industry best practices for TMF management.

Responsibilities

  • Responsible for TMF quality and compliance across Emmes studies, ensuring TMFs follow ICH E6 Good Clinical Practices (GCP), applicable SOPs, other regulatory requirements, and quality standards.
  • Develops and implements an industry-leading TMF strategy, including TMF metrics, continual process improvement programs, and the evaluation and adoption of new technology.
  • Leads the global TMF team and is accountable for the global performance of staff, including staff training, staff development, resource management, and staff engagement activities.
  • Directly supports regulatory inspections and audits, representing TMF, and serves as a subject matter expert on TMF management, providing guidance and support to cross-functional teams and internal and external stakeholders.
  • Oversees eTMF systems' configuration and configuration changes through established change control processes, including prioritization, implementation, data migration, training/retraining on system, and collaboration with stakeholders.
  • Reviews, communicates, and mitigates risks/deficiencies of TMF deliverables based on performance trend analyses and metrics.
  • Leads the overall TMF department performance and addresses quality findings in collaboration with QA representatives, including CAPA, audit findings, and internal quality review findings.
  • Collaborates with other Clinical Operations and department Directors/Leaders on the implementation of new processes and continuous review of current processes/agreed process improvements within the organization.
  • 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.
  • Communicates corporate goals to the TMF team and models corporate culture through vision, action, and learning.
  • Holds direct reports and staff accountable for high performance while promoting engagement and fostering a value-based culture of accountability.
  • Ensures regional TMF job descriptions and career paths are aligned globally, maintained, and communicated.

Required Attributes

Vision and Strategy

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

Team Building

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

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

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

Credibility and Integrity

Developing 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.

Continuous Improvement/Change Management

Promptly takes the required corrective action when necessary.

Communication

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

Supervisor Responsibilities

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

Qualifications

  • 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.
  • At least 5 years of experience managing a global team. Past participation in regulatory inspections.
  • Experience in developing, implementing, and measuring success in departmental strategic plans.
  • Thorough knowledge of and experience using electronic TMF application(s) for major non-proprietary system(s), TMF management metrics, and clinical trial management systems.
  • Thorough knowledge of all sections of the TMF Reference Model (CDISC).
  • 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), and Good Documentation Practice (GDP) principles.
  • Ability to work modified schedule to attend meetings with staff and clients in EU, India, and US time zones.

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