TMF Support Analyst

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TMF Support Analyst (SA)

Levels: I, II, III

Location: REMOTE

LMK Clinical Research Consulting is a division of the family of companies that form TransPerfect.

At LMK, we believe the Trial Master File (TMF) is the foundation of every clinical trial, and a strong foundation is key to the overall health and stability of any clinical program. LMK offers a variety of services bespoke to our clients’ unique needs--from implementation to archival. This may comprise short-term staff augmentation or complete maintenance of the TMF environment by a team of our industry experts. Ensuring TMF quality is the single most important deliverable of a clinical trial and LMK supports our clients becoming the first-to-market through speed and readiness of the TMF.

LMK’s TMF Support Analyst is the Quality Control Expert and ensures accuracy and completeness of all clinical documentation within the TMF. The clinical trial documentation must be consistent with the Trial Master File Specifications, submission/inspection readiness criteria and comply with LMKs (or clients) SOPs and regulatory requirements.

Dependent on assignment, LMK’s TMF SAs may:

• Perform TMF Quality Reviews
• Remediate findings resulting from TMF Quality Reviews
• Perform document level Quality Checks
• Index and/or activate documents in an eTMF
• Migrate Paper/Electronic TMFs
• Provide Audit/Inspection support
• Author and maintain TMF Management Plans
• Generate reports and metrics
• Serve as a TMF Subject Matter Expert (SME)
• Other activities as directed by the Project Lead

There are three (3) tiers of TMF Support Analysts reflecting increased experience and responsibility with each subsequent level:

Level I: TMF Associate Support Analysts (ASA)

• Performs tasks with support

Level II: TMF Support Analysts (SA)

• Performs tasks independently

Level III: TMF Senior Support Analysts (SSA)

• Performs tasks independently
• Provides support to subordinate tiers to perform tasks

Your experience includes:

• Bachelor’s Degree or equivalent
• 2 years of TMF Experience or professional equivalent
• Capability to self-supervise/work remotely
• Capability to work in a global environment with internal and external partners
• Fluency in English; strong written and verbal communications skills
• Travel as required (<5%)
• Proficiency in MSOffice Suite (i.e., Outlook, Word, PowerPoint, Excel)
• Familiarity with Smartsheet preferred
• GCP Certification preferred

Successful candidates will also possess unwavering integrity, irreproachable attention to detail, and impeccable record keeping.

Whether you continue your career at LMK or venture into another department at TransPerfect, there are numerous growth opportunities. All departments offer career growth and development that can combine your skills, interest and experience. We encourage our employees to have a continuous dialogue with management about growth oppportuinties throughout your tenure with the company.

LMK Clinical Research Consulting is a recognized leader in Trial Master File (TMF) document management services and solutions for the life sciences industry. Since our founding in 2015, our innovation and tailored approach has set trends across the industry. We were the first—and remain the only—provider of accredited TMF Professional certifications. In 2021, we joined forces with another industry leader to leverage global infrastructure and exponential growth.

For more than 25 years, Transperfect has honed a culture where all kinds of ideas are shared and new ventures are not only welcomed, but also encouraged. In this fast-paced environment, employees are intellectually stimulated so they can grow alongside the organization. From Intern to President, we believe that every single employee should have a voice and contribute to the amazing services we offer our clients.

We also offer a comprehensive benefits package including medical, dental, and vision insurance, 401k matching, membership to child-care providers, and other TransPerks. You even get your birthday off because let's face it, we're stoked that you were born.

TransPerfect provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law

For more information on the TransPerfect Family of Companies, please visit our website at www.transperfect.com or jump to LMK directly at www.lmkclinicalresearch.com.