eTMF Manager
eTMF Manager
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Job Description
The Role:
Moderna Services Inc. seeks an eTMF Manager for its Cambridge Massachusetts location.
Heres What Youll Do:
Apply U.S. and international regulatory requirements to lead the execution of TMF Operations processes and strategy and assist with establishing and maintaining TMF monitoring and reporting for clinical trials.
Maintain effective communication with clinical study teams Contract Research Organization (CRO) staff and eTMF vendor personnel throughout study startup maintenance and closeout.
Work with crossfunctional study teams and partners to help analyze vendor system and process changes and impact to applicable internal processes.
Support TMF document filing into Moderna eTMF system performs quality checks of documents uploaded and respond to inquiries regarding TMF management and contents.
Author study TMF plans TMF Indexing work instruction manuals data capture guidelines and standard operating procedures.
Deliver Key Performance Indicator (KPI) reports eTMF reports to the study team manage expectations track ongoing KPI across the study team in conjunction with the Clinical Trial Managers and Clinical Project Leads and monitor the TMFs for completeness and trends.
Support system updates by participating in user acceptance testing and system enhancement discussions.
Complete other TMF documentrelated tasks as required by the study teams or functional groups in Clinical Development Operations.
Drive and support portfoliolevel initiatives including process change management and development.
Mentor and provide highlevel oversight of junior TMF positions within assigned portfolio.
Provide process subject matter expertise and support for TMF creation maintenance closure and transfer per company and CRO Standard Operating Procedures (SOPs) and standards.
Support CRO and partnership migration and integration activities TMF reporting and compliance.
Provide best practice guidance and support to ongoing and adhoc TMF projects and initiatives.
Provide process and planning support to the Clinical Trial Managers and Clinical Project Leads for TMF related remediation and process execution as needed.
Support integration of partnered or acquired clinical information including transfer of TMFs in compliance with applicable regulations and best practices.
Proactively stay current with best practices and recommend applications across portfolios to continuously improve TMF operations processes.
Lead projects in support of study or portfolio TMF objectives and attend standing crossfunctional meetings.
May telecommute 100% from anywhere in the U.S.
Heres What Youll Bring to the Table:
Minimum requirements:
Requires a Masters degree in Biology Pharmacy or related field and 3 years of experience in the position offered or as a TMF Lead Specialist Coordinator or related position within the pharmaceutical and biotech industry. Alternatively Employer will accept a Bachelors degree in the stated fields and 5 years of progressive postbaccalaureate experience in the stated positions.
Must have 3 years of experience with the following:
Applying U.S. and international regulatory requirements for TMF used in submission of a new drug approval;
Working with specialist functions within clinical trial teams to advise on acceptable records of clinical trial conduct;
Collaborating with clinical trial teams and vendors to resolve conflicts and escalate issues;
Providing TMF inspection readiness data and analysis to trial teams and management; and
Performing quality checks on documents to resolve high risk document issues.
Must have 2 years of eTMF document management experience.
May telecommute 100% from anywhere in the U.S.
Apply at (Job ID: R17746) or email resume and cover letter to with subject line: R17746.
#DNI
At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global wellbeing resources are designed to support youat work at home and everywhere in between.
- Bestinclass healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
- A holistic approach to wellbeing with access to fitness mindfulness and mental health support
- Lifestyle Spending Accounts to personalize your wellbeing journey
- Family planning and adoption benefits
- Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary yearend shutdown
- Savings and investment opportunities
- Locationspecific perks and extras
About Moderna
Since our founding in 2010 we have aspired to build the leading mRNA technology platform the infrastructure to reimagine how medicines are created and delivered and a worldclass team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission values and mindsets every day our people are the driving force behind our scientific progress and our culture. Together we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.
As we build our company we have always believed an inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70% inoffice structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.
Moderna is a smokefree alcoholfree and drugfree work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!
Moderna is committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable law.
Moderna is an EVerify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at . (EEO Employer)
#LITR2Required Experience:
Manager
Employment Type
Full-Time
