TMF Manager

12 hours ago

Cambridge, United States Beacon Hill Life Sciences - Boston Full time
Job DescriptionJob Description

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. 
Company DescriptionBeacon 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.

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 DescriptionBeacon 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.\r
\r
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/\r
\r
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.

  • TMF Manager

    6 days ago

    Cambridge, United States Integrated Resources, Inc ( IRI ) Full time

    About the Role - This position reports into a Sr. Manager or Associate Director of Clinical Operations (or above). This role maintains 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...

  • TMF Manager

    6 days ago

    Cambridge, United States Integrated Resources, Inc ( IRI ) Full time

    About the Role - This position reports into a Sr. Manager or Associate Director of Clinical Operations (or above). This role maintains 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...

  • TMF Manager

    6 days ago

    Cambridge, United States Integrated Resources, Inc ( IRI ) Full time

    Title: TMF Manager-Clinical Operations Location: Cambridge, MADuration: 7 months+What will you do? This position reports into a Sr. Manager or Associate Director of Clinical Operations (or above). This role maintains TMFs ensuring they are current and inspection-ready for internal and external entities. The right candidate will possess an understanding of...

  • TMF Manager

    6 days ago

    Cambridge, United States Integrated Resources, Inc ( IRI ) Full time

    Title: TMF Manager-Clinical Operations Location: Cambridge, MADuration: 7 months+What will you do? This position reports into a Sr. Manager or Associate Director of Clinical Operations (or above). This role maintains TMFs ensuring they are current and inspection-ready for internal and external entities. The right candidate will possess an understanding of...

  • TMF Manager

    3 days ago

    Cambridge, United States Planet Pharma Full time

    What will you do?This position reports into a Sr. Manager or Associate Director of Clinical Operations (or above).This role maintains the company'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...

  • TMF Manager

    3 days ago

    Cambridge, United States Planet Pharma Full time

    What will you do?This position reports into a Sr. Manager or Associate Director of Clinical Operations (or above).This role maintains the company'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...

  • TMF Manager

    3 days ago

    Cambridge, United States Proclinical Staffing Full time

    TMF Manager - Contract - Cambridge, MAProclinical is partnered with a biotech company seeking a TMF Manager for a contract role in Cambridge, MA. Primary Responsibilities:The successful candidate will maintain Trial Master Files (TMFs) to ensure they are current and inspection ready. They will need a strong understanding of clinical trial conduct, TMF...

  • TMF Manager

    3 days ago

    Cambridge, United States Proclinical Staffing Full time

    TMF Manager - Contract - Cambridge, MAProclinical is partnered with a biotech company seeking a TMF Manager for a contract role in Cambridge, MA. Primary Responsibilities:The successful candidate will maintain Trial Master Files (TMFs) to ensure they are current and inspection ready. They will need a strong understanding of clinical trial conduct, TMF...

  • TMF Manager

    6 days ago

    Cambridge, United States The Steely Group Full time

    TMF Manager - Contractor Pay Rate: $70-95 per hourLocation: Hybrid, Cambridge7 month contract to extensions/conversionWork Authorization : Green Card, US CitizenPreferred years of experience : 5+ YearsTravel Required : No travel requiredThis position reports into a Sr. Manager or Associate Director of Clinical Operations. This role maintains TMFs ensuring...

  • TMF Manager

    6 days ago

    Cambridge, United States The Steely Group Full time

    TMF Manager - Contractor Pay Rate: $70-95 per hourLocation: Hybrid, Cambridge7 month contract to extensions/conversionWork Authorization : Green Card, US CitizenPreferred years of experience : 5+ YearsTravel Required : No travel requiredThis position reports into a Sr. Manager or Associate Director of Clinical Operations. This role maintains TMFs ensuring...

  • TMF Specialist

    2 months ago

    Cambridge, United States Beacon Hill Life Sciences - Boston Full time

    Job DescriptionJob DescriptionPosition Summary:The Contract Trial Master File (TMF) Specialist will assist in and oversee all aspects of TMF Management. The role oversees the collection, quality assessment, processing and archiving of clinical trials documents from both external and internal sources. The TMF Specialist is responsible for ensuring standard...

  • Trial Master File

    6 days ago

    Cambridge, United States Integrated Resources, Inc ( IRI ) Full time

    Client is a global precision therapy company that invents life-changing therapies for people with cancer and hematologic disorders. Applying an approach that is both precise and agile, we create medicines that selectively target genetic drivers, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research...

  • Trial Master File

    6 days ago

    Cambridge, United States Integrated Resources, Inc ( IRI ) Full time

    Client is a global precision therapy company that invents life-changing therapies for people with cancer and hematologic disorders. Applying an approach that is both precise and agile, we create medicines that selectively target genetic drivers, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research...

  • Planet Pharma | TMF Manager | cambridge, ma

    3 days ago

    cambridge, United States Planet Pharma Full time

    What will you do?This position reports into a Sr. Manager or Associate Director of Clinical Operations (or above).This role maintains the company'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...

  • Proclinical Staffing | TMF Manager

    3 days ago

    cambridge, United States Proclinical Staffing Full time

    TMF Manager - Contract - Cambridge, MAProclinical is partnered with a biotech company seeking a TMF Manager for a contract role in Cambridge, MA. Primary Responsibilities:The successful candidate will maintain Trial Master Files (TMFs) to ensure they are current and inspection ready. They will need a strong understanding of clinical trial conduct, TMF...

  • The Steely Group | TMF Manager

    6 days ago

    cambridge, United States The Steely Group Full time

    TMF Manager - Contractor Pay Rate: $70-95 per hourLocation: Hybrid, Cambridge7 month contract to extensions/conversionWork Authorization : Green Card, US CitizenPreferred years of experience : 5+ YearsTravel Required : No travel requiredThis position reports into a Sr. Manager or Associate Director of Clinical Operations. This role maintains TMFs ensuring...

  • The Steely Group | TMF Manager

    5 days ago

    cambridge, United States The Steely Group Full time

    TMF Manager - Contractor Pay Rate: $70-95 per hourLocation: Hybrid, Cambridge7 month contract to extensions/conversionWork Authorization : Green Card, US CitizenPreferred years of experience : 5+ YearsTravel Required : No travel requiredThis position reports into a Sr. Manager or Associate Director of Clinical Operations. This role maintains TMFs ensuring...

  • Trial Master File

    3 weeks ago

    Cambridge, United States Bicycle Therapeutics Full time

    Job DescriptionWe are looking for a Trial Master File (TMF) Specialist to support our growing TMF Operations Department. The right candidate will have experience in TMF study management. They will work with Bicycle study teams and with our CRO partners to ensure that our eTMF is inspection ready throughout the conduct of the study.  This role will support...

  • Integrated Resources, Inc

    4 days ago

    cambridge, United States Integrated Resources, Inc ( IRI ) Full time

    About the Role - This position reports into a Sr. Manager or Associate Director of Clinical Operations (or above). This role maintains 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...

  • Integrated Resources, Inc

    4 days ago

    cambridge, United States Integrated Resources, Inc ( IRI ) Full time

    About the Role - This position reports into a Sr. Manager or Associate Director of Clinical Operations (or above). This role maintains 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...