TMF Manager - Clinical Operations
Beacon Hill Staffing Group, LLC

This role maintains client's TMFs ensuring they are current and inspection-ready for internal and external entities. The right candidate will possess an understanding of clinical trial conduct, TMF structure (DIA Reference Model), eTMF systems, and best documentation practices.

Responsibilities

• Responsible for managing clinical document quality/control/filing, and the Trial Master Files (TMFs).
• Performs set up activities, document filing and oversight of internal e/TMF applications
• Supports Clinical Operations Study Leaders in the QC and oversight of CROs' e/TMF applications
• Functional lead for specified e/TMF platform with vendor(s)
• Provide support and guidance to CROs and support staff to ensure accurate and timely eTMF filing and maintenance according to ICH GCP guidelines
• Provide training to eTMF users and external parties (CROs)
• Partner with management and others to support functional and organizational initiatives, to drive new procedures and ideas, and to function as an advocate for processes and decisions
• Supports the development and review of standard operating procedures and work instructions related to clinical document management, as appropriate
• Creates and maintains written instructions, SOPs, guidelines and plans as they relate to e/TMFs and document control
• Updates and maintains Naming and Filing Guide(s) for relevant e/TMF systems
• Work in collaboration with all applicable functional areas
• Work in collaboration with Clinical Operations Management to drive new procedures and processes within the department, as appropriate

Qualifications

• Bachelor's degree or equivalent combination of education/experience in science or health- related field
• Minimum 5 years of e/TMF experience for a pharmaceutical, biotechnology company, or contract research organization
• Thorough knowledge of all sections of the DIA Reference Model (current version)
• Thorough knowledge of documents from various functional areas and their appropriate e/TMF filing requirements
• Thorough knowledge of International Council for Harmonization (ICH) Good Clinical Practice (GCP) as well as Good Documentation Practice (GDP) principles
• Experience with eTMF system or software to include but not limited to development of SOPs, user training manual, performing UATs and validations, etc.
• Thorough knowledge of electronic TMF application(s), for major non-proprietary system(s) and ability to prioritize related tasks based on project goals

Additional Experience

• Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
• Creative problem solver with excellent communication and public speaking skills.
• Proficiency in developing and delivering educational materials, both written and oral
• Ability to engage in cross-functional interactions with internal and external staff
• Global trial experience
• Strong interpersonal and organizational skills are needed, with a high degree of attention to detail.

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

California residents: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/

Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

Company Profile:

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com .

We look forward to working with you!

Beacon Hill. Employing the Future™

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