Associate Director, Clinical Records & Information Management

Description

The Associate Director, Clinical Records & Information Management will partner with cross functional teams as well as Clinical Research Organization (CRO and Functional Service Provider (FSP) to ensure timely and quality delivery of the TMF.

This role is a member of the Clinical Records leadership team to ensure optimum implementation of the TMF technical capabilities and oversight of standardization, training, quality, and timely clinical trial documentation across the clinical program.

The ideal candidate for this role will have extensive understanding of eTMF & CTMS process and systems, pervious experience with operational study and site management and a demonstrated track record of building and successful delivery of TMF operational quality oversight.

The ideal candidate will have a proven track record of innovation, a strong understanding of current technological challenges, limitations and creative solutions to deliver on business expectations, improve overall TMF Compliance and quality oversight capabilities.

PRIMARY RESPONSIBILITIES :

• Support TMF compliance through strategy, planning, and execution of metrics, Governance and oversight programs.
• Lead, monitoring, and reporting on expected Key Performance Indicators (KPIs), Service Level Agreements (SLA) with CROs, functions and suppliers.
• Lead risked based approach to TMF oversight and metrics.
• Lead team of TMF Quality Specialists, providing strategic direction, strategy and operationalization of TMF Quality programs
• Analysis of TMF data to proactively identify and alert the organization of TMF quality or compliance concerns. Manage and own escalation process if quality measures are not met e.

g., Functional QC, CRO Oversight QC etc.

• Develop, implement and manage TMF performance improvement plans when deficiencies are found.
• Champion the use of master data, integration, and strategic use of artificial intelligence to provide transformative capabilities to Gilead and Kite.
• Influence future TMF direction and capabilities by identifying and leading activities which build efficiencies, automation, standardization, and adoption of best practices across Gilead and Kite.
• Collaborate with key internal and external stakeholders to assess process alignment and prioritize procedural and TMF system changes to ensure continued improvements and compliance.
• Represent Clinical Records in cross-functional projects, initiatives, governance and compliance forums.
• Lead TMF Quality and Oversight via KPIs and process for on-going monitoring of vendor and Gilead TMF performance to KPIs
• Report TMF metrics trending analysis as appropriate with resolution plans to proactively identify issues.
• Review and responds to TMF content quality issues and identifies trends and alerts management of trends.
• May recruit, hire, mentor, and manage direct reports and support their professional development.
• Strong communication and influence skills and ability to create clear sense of direction is necessary.
• Excellent verbal, written, interpersonal and presentation skills are required.
• Extensive knowledge and understanding of FDA, EMEA, ICH, GCPs governing the maintenance of clinical TMF.

QUALIFICATIONS :

• BA or BS and 12+ years’ experience in compliance and trial master file in pharmaceutical / biotechnology industry.
• Excellent working knowledge of GCP regulations.
• Direct experience with Veeva Clinical Vault (eTMF / CTMS) Vault Admin Certification preferred
• Experience in deployment and management of Expected Document Lists (EDLs) and Milestones, preferably with Veeva Vault Clinical
• A passion for quality and compliance.
• Project management, resource management and planning
• Ability to analyze complex situations, develop multiple options / solutions within regulatory guidance.
• Strong change management skills and conflict resolution skills are essential. Ability to remain focused in high-stress situations.
• Background in delivering high levels of customer service
• Ability to work independent, within a broad regulatory framework
• Direct experience at the Sponsor level with TMF Governance and Metrics.
• Ability to build strong relationships to foster a collaborative approach to proactive compliance activities.
• Document Records Management experience using electronic TMF platforms.
• Strong verbal, written, communication, and interpersonal skills.

The salary range for this position is : $191,335.00 - $247,610.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.

These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit :

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States :

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.