27 applicants

Company

Original Job Post

Exelixis · 2 days ago

Associate Trial Master File Director

King of Prussia, PA

Full-time

Onsite

Director

$143K/yr - $203K/yr

9+ years exp

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BiotechnologyHealth Care

H1B Sponsorship

Hiring Manager

Jodie Donaldson

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Responsibilities

Delivers Project Management principles within the team to track, monitor and deliver on all TMF-related work.

Manages the Veeva roadmap for the integration of Veeva Platforms with eTMF.

Designs and implements RPA technology within TMF Management to streamline processes.

Ensures internal audits and Health Authority inspections are set-up appropriately in Veeva eTMF.

Represents TMF Management for all Veeva releases and enhancements.

Develops Zone Owners based on the TMF Reference Model to increase efficiencies and user base.

Ensures reports and dashboards are developed and available for teams in Veeva eTMF.

Provides oversight to TMF Management team in developing eTMF educational sessions for the user community.

Helps develop a TMF Governance structure to support key decisions and actions around eTMF.

Ensures TMF compliance with industry standards and regulations for Inspection Ready studies.

Oversees clinical trial document quality control activities to ensure study TMFs are inspection ready.

Supports overall goals and objectives of the function and company.

Leads additional initiatives for TMF, Clinical Compliance & Risk Management or Development Operations as needed.

Provides mentorship, leadership, and guidance to junior level staff or contract employees.

Contributes to the design, development, and deployment of eTMF in a collaborative teamwork setting.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

TMF knowledgeETMF systemsVeeva Vault ClinicalTechnical standardsProblem solvingCommunicationAttention to detailCritical thinkingOrganizational skillsTime managementProject managementLeadershipChange managementRecords ManagementBusiness ProcessesProblem-Solving

Required

BS/BA degree in related discipline and a minimum of eleven years of related experience; or,

MS/MA degree in related discipline and a minimum of nine years of related experience; or,

Equivalent combination of education and experience.

10+ years of experience working in a pharmaceutical or other highly regulated corporate environment, including 5+ year in experience with electronic document management systems, with progressive experience managing active, inactive, and archived records, analyzing business processes, and developing and implementing Records Management policy and procedures.

Expert knowledge of TMF for set-up and maintenance.

Knowledge of eTMF systems are desirable but experience in Veeva Vault Clinical is required.

Good communication skills both oral and written are a must. Applies strong analytical and business communication skills.

Excellent attention to detail, strong critical thinking, and problem solving.

Excellent organizational, time management, and project management skills.

Applies technical standards, principles, theories, concepts, and techniques.

Demonstrates experience leading in the matrix environment to deliver projects, develop clinical plans and manage change.

Preferred

Broad understanding of business processes in a wide variety of functional areas within a large, international pharmaceutical company, and the ability to translate the records management needs of those business processes into clear and concise terminology, logical and hierarchical arrangements of records types and series, and clear and effective procedures for filing and managing both records and non-records.

Benefits

401k plan with generous company contributions

Group medical, dental, and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus program

Sales-based incentive plan (for field sales staff)

Opportunity to purchase company stock

Receive long-term incentives

15 accrued vacation days in the first year

17 paid holidays including a company-wide winter shutdown in December

Up to 10 sick days throughout the calendar year

Company

Exelixis

Glassdoor

2.1

Exelixis works is focused on discovering, developing and commercializing therapies for the treatment of cancer and other serious diseases.

Founded in 1994

Alameda, California, USA

1,001-5,000 employees

http://www.exelixis.com

H1B Sponsorship

Exelixis has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

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2021 (26)

2020 (19)