TMF Specialist (Remote – PST Based Required)

Advanced Clinical; California (MO); Remote; USD 80,000 - 110,000; Full time

Benefits offered by this job

Flexible work schedules

Supportive work environment

Career advancement opportunities

Job summary

A leading clinical development organization is seeking a TMF/Sr. TMF Specialist for a remote position in California. The role involves ensuring adherence to regulatory requirements and maintaining the Trial Master Files (TMF) inspection readiness. The ideal candidate will have 3-5 years of TMF experience, strong Veeva Vault eTMF skills, and a Bachelor's degree. This position offers a chance to make significant contributions to clinical trials in a fast-paced environment.

Qualifications

• Minimum of 3-5 years of TMF experience required.
• Hands-on Veeva Vault eTMF experience.
• Oncology experience preferred.
• Experience with global clinical trials is desirable.
• Subject Matter Expert knowledge of clinical trial documentation.

Responsibilities

• Monitor adherence to ICH/GCP Guidelines for TMF.
• Ensure TMF documents are inspection-ready.
• Work with study team on TMF Plan adherence.
• Conduct quality reviews of the TMF content.
• Collaborate with teams to upload Essential Documents.

Skills

Quality review

Regulatory compliance

Collaboration

Risk assessment

Project management

Education

Bachelor’s Degree

Tools

Veeva Vault eTMF

Job description

Overview

We are currently searching for a skilled professional to join a well-known client’s team in California as a TMF/Sr. TMF Specialist. This remote role will provide primary support to ensure inspection readiness of Trial Master Files (TMF). Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

Responsibilities

• Monitor the adherence to ICH/GCP Guidelines, regulatory requirements, and client policies as it relates to the completeness/accuracy of the TMF
• Ensure the required documents reside in the TMF as per the Study-Specific Master TMF Plan and Master TMF Index and are always inspection-ready
• Work with the study team to adhere to the TMF Plan and to update the Study Master TMF Index
• Collaborate with team members to ensure the timely uploading of all Essential Documents in the TMF
• Perform risk-based quality reviews of the TMF content
• Follow up with the appropriate functional group or document owner to mitigate, as per the established review schedule
• Resolve noncompliance to improve the accuracy of the TMF
• Identify TMF trends and escalate concerns to management
• Generate, organize, and deliver on TMF performance metrics at the site, country, and study level
• Ensure the TMF is ready to be archived at study completion
• Assist in overall change management and build collaborative relationships with cross-functional teams and third-party vendors
• Provide support to TMF implementation, internal audits, and regulatory inspections

Experience

• Minimum of 3-5 years of TMF experience in study start-up, maintenance/closeout, and performing quality/completeness reviews required
• 3+ years of hands-on Veeva Vault eTMF experience required.
• Oncology experience preferred but not required. (Please list therapeutic areas on CV)
• Experience in a start-up with global clinical trials is highly desirable.
• Demonstrated experience in independently managing/handling concurrent tasks in a fast-paced environment and delivering results within tight timelines desired
• Subject Matter Expert (SME) knowledge of clinical trial documentation, DIA Reference Model, clinical trial activities, and related terminology

Education

• Minimum of a Bachelor’s Degree required

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services, including CRO, Functional Support, Quality and Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent and Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available