TMF Project Manager

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Who We Are:

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.

Our team of TMF Professionals is composed of highly skilled and experienced individuals who are committed to elevating the role of the TMF in the clinical trial space and working collaboratively with our clients to ensure their TMF is working as a tool for success.

What You Will Be Doing:

LMK’s TMF Project Manager is the primary point of contact that liaises between the LMK Project Team and the client. Typically, the TMF PM is responsible for ensuring standardization of processes, training, quality across the LMK Project Team, as well as adherence to the scope, schedule, and budget. The TMF PM manages the clinical trial documentation and provides updates to leadership, as directed.  

LMK’s TMF PM will: 

• Review contractual documentation to understand project scope and expectations

• Provide any required Project Specific Training to Team Members 

• Assign and track Project Team activity 

• Provide support and guidance to assigned Project Team members

• Ensure adherence to all applicable Regulations, LMK processes, and client requirements

• Monitor project status and progress to ensure adherence to Project Schedule and Budget

• Identify and address issues that jeopardize Project Schedule and Budget

• Function as TMF Subject Matter Expert (SME) 

• Maintain any and all documentation to evidence the above

Additionally, dependent on the assignment, LMK’s TMF PM may: 

• Host client calls and provide Project updates to ensure client satisfaction

• Report on Project Status and progress to LMK Leadership

• Escalate issues to LMK Leadership, as appropriate

• Collaborate with Line Managers to identify performance issues

• Maintain any and all documentation to evidence the above

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

Level I: TMF Associate Project Manager (APM)

• Performs tasks with support

Level II: TMF Project Manager (PM)

• Performs tasks independently

Level III: TMF Senior Project Manager (SPM)

• Performs tasks independently

• Provides support to subordinate tiers to perform tasks

Who We Are Looking For:

Your experience includes:

• Bachelor’s Degree or equivalent 

• 5 years of TMF Experience or professional equivalent

• 2 years of Project Management Experience or professional equivalent

• Capability to self-supervise/work remotely

• Capability to work in a global environment with internal and external partners

• Demonstrating good judgment when managing competing priorities

• Fluency in English; excellent written and verbal communications skills 

• Professional demeanor interacting with/presenting to cross-functional stakeholders

• Working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations

• Understanding of clinical drug development and clinical trials operations 

• Travel as required (<10%)

• 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.

Where Your Career Is Going:

Whether you continue your career at LMK or venture into another department at TransPerfect, there are a lot of 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. 

Why LMK:

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, providers of accredited TMF Professional certification. In 2021, we joined forces with another industry leader to leverage a global infrastructure with 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.