Associate Director, Clinical Records - Trenton, United States - Gilead Sciences

Gilead Sciences Trenton, United States

4 weeks ago

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Description

Associate Director, Clinical Records & Information Management

Associate Director, Clinical Records & Information Management

United States - California - Foster City, United States - New Jersey - Parsippany, United States - Washington - Seattle

Clinical Development & Clinical Operations

Regular
Job Description

At Gilead, we're creating a healthier world for all people.

For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.

We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

We empower our leaders to step up, share ideas, listen, learn, and lead.

We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged.

We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations.

Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

Join Gilead and help create possible, together.

Job Description

At Gilead, we're creating a healthier world for all people.

We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

We empower our leaders to step up, share ideas, listen, learn, and lead.

We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged.

We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations.

Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

Join Gilead and help create possible, together.

Job 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, $247, 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.
For more information about equal employment opportunity protections, please view the 'Know Your Rights'

poster.

NOTICE:

EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For jobs in France:

Conformément à la Loi « Informatique et Libertés » (06/01/78), nous vous informons du fait que les données personnelles renseignées pourront faire l'objet d'un traitement informatique par Gilead et pourront être transmises aux Organismes Sociaux.

Par ailleurs, vous disposez d'un droit d'accès, de rectification et de suppression des données vous concernant.

Vous pouvez exercer ce droit en contactant:

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Job Requisition ID

R0040280
Full Time/Part Time

Full-Time
Job Level

Associate Director
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