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TMF Specialist

Job Description

Title: 19-07986 / TMF Specialist
Location: San Rafael, CA
Industry: Biotechnology / Pharma
Position Type: Initial 12-month contract

Local residents who submit a cover letter will be viewed first

A chance to work for an amazing company, who likes to try before they buy! This mid-size company is leading the pack in their unique therapeutic area (that tugs at the heart strings)!

TOP SKILLS NEEDED:
1. TMF experience
2. Attention to detail
3. Communication
4. ability to do very monotonous work!
 
Summary- this is a JR level position (must have 1-2 years within the Pharma/Drug development industry). MUST have direct experience with working with Trail Master Files (TMF) and this must be noticeable in your resume! Other key words in your resumé are: eTMS, Veeva Vault, QMS Systems, Pharma, Drug Development. 

This role is heavy in document processing and this is not considered a 'clinical' role. 

 
Job Duties:
  • Facilitate the creation of the enterprise and study specific TMF management tools
  • Maintain TMF Management Plans and TMF Content Lists; work with the Study Teams to check and verify the plans and communicate the importance of each document to the Study Team based on risk level
  • Coordinate creation of the TMF filing locations within the company based on the study specific TMF Content List
  • Participate in the Quality Control of documents (paper and electronic) submitted to the TMF or eTMF
  • Facilitate the review and submission of TMF records to Records Management personnel
  • TMF-Related Collaboration & Support
  • Support the coordination of the transfer of study-specific trial master files from the CRO
  • Participate in Study Team meetings and provide/present regular TMF metrics updates
  • Maintain awareness of study events and the associated documentation requirements through collaboration with Study Team
  • Support Study Teams and designated Study Team Content owners in understanding their TMF-related responsibilities, requirements and expectations; act as an ad-hoc member of the Study Team
  • Act as point person for Study Team TMF questions and manage close-out of TMF related issues
  • Support the Study Team in TMF document retrieval during Audits and Inspections (paper and electronic)
  • Manage the TMF content list and TMF Comprehensive Review tracker
  • Provide TMF metrics: completeness and quality of TMF documentation and content, including the percent completeness and the risk level of outstanding items on a periodic basis or as requested by DevSci management
  • Participate in the conduct of quality review of the TMF for each assigned study on an annual basis per the time points captured in the study-specific TMF Plan
  • Identify any corrective actions which must be addressed and assigned
  • Support the submission of documented evidence of the TMF Quality Review to the TMF
  • Support the management of TMF documentation issues throughout the lifecycle of an assigned study
  • Participate in the implementation of standards and processes for DevSci records management to verify compliance with relevant regulations
  • Support and carry out the processes associated with the storing, archiving, indexing, scanning and classifying records
  • Process records (e.g., track, scan, archive) in compliance with DevSci Records SOPs
  • Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to the management of records in DevSci Records
  • Provide guidance on best practices for record handling, retrieval and archival procedures
  • Provide archived DevSci records to users (e.g. internal staff and/or Auditors) for review
  • Oversee the provision of the required documents at the time of Regulatory Authority Inspection or internal Audits
  • Respond to TMF and non-TMF internal and/or external information inquiries related to DevSci records
    Systems Development
  • Participate in the development, implementation, and maintenance of classification and filing systems per administrative, research, regulatory, legal and financial requirements
  • Manage the off-site storage of DevSci records and the contract with the storage vendor, including vendor oversight
  • Participate in the development, implementation, and maintenance of internal databases used to manage records
Qualification/Education:
  • BA/BS in life sciences or technical area; experience in lieu of education may be considered
  • 2+ years of relevant pharmaceutical industry experience
  • Demonstrate foundational technical skills in Regulations and Good Practices, as well as Quality Management
Preferred Skills/Experience:
  • Relevant certification, such as Registered Quality Assurance Professional, Certified Quality Auditor, CCRA or CCRC, Certified Clinical Research Professional, or Regulatory Affairs Certification
  • Understanding of key regulatory agencies and regulatory inspection processes
  • Understanding of the objectives/purpose and key milestones/filings of each drug development phase (Pre-Clinical, phases I-IV)
  • Understanding of GxP principles, their importance, and how they apply to operational activities currently being performed
 
*Those authorized to work in the U.S. are encouraged to apply / Unable to Process H1B visa at this time / Unable to work on a C2C basis for this role* 

Job Requirements

 

Job Snapshot

Location US-CA-San Rafael
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Clinical & Scientific, Other
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Company Overview

Ascent

The Ascent Services Group (ASG) is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. ASG’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Learn More

Contact Information

US-CA-San Rafael
Bonnie Galley
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Snapshot
Ascent
Company:
US-CA-San Rafael
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Clinical & Scientific, Other
Store Type:

Job Description

Title: 19-07986 / TMF Specialist
Location: San Rafael, CA
Industry: Biotechnology / Pharma
Position Type: Initial 12-month contract

Local residents who submit a cover letter will be viewed first

A chance to work for an amazing company, who likes to try before they buy! This mid-size company is leading the pack in their unique therapeutic area (that tugs at the heart strings)!

TOP SKILLS NEEDED:
1. TMF experience
2. Attention to detail
3. Communication
4. ability to do very monotonous work!
 
Summary- this is a JR level position (must have 1-2 years within the Pharma/Drug development industry). MUST have direct experience with working with Trail Master Files (TMF) and this must be noticeable in your resume! Other key words in your resumé are: eTMS, Veeva Vault, QMS Systems, Pharma, Drug Development. 

This role is heavy in document processing and this is not considered a 'clinical' role. 

 
Job Duties:
  • Facilitate the creation of the enterprise and study specific TMF management tools
  • Maintain TMF Management Plans and TMF Content Lists; work with the Study Teams to check and verify the plans and communicate the importance of each document to the Study Team based on risk level
  • Coordinate creation of the TMF filing locations within the company based on the study specific TMF Content List
  • Participate in the Quality Control of documents (paper and electronic) submitted to the TMF or eTMF
  • Facilitate the review and submission of TMF records to Records Management personnel
  • TMF-Related Collaboration & Support
  • Support the coordination of the transfer of study-specific trial master files from the CRO
  • Participate in Study Team meetings and provide/present regular TMF metrics updates
  • Maintain awareness of study events and the associated documentation requirements through collaboration with Study Team
  • Support Study Teams and designated Study Team Content owners in understanding their TMF-related responsibilities, requirements and expectations; act as an ad-hoc member of the Study Team
  • Act as point person for Study Team TMF questions and manage close-out of TMF related issues
  • Support the Study Team in TMF document retrieval during Audits and Inspections (paper and electronic)
  • Manage the TMF content list and TMF Comprehensive Review tracker
  • Provide TMF metrics: completeness and quality of TMF documentation and content, including the percent completeness and the risk level of outstanding items on a periodic basis or as requested by DevSci management
  • Participate in the conduct of quality review of the TMF for each assigned study on an annual basis per the time points captured in the study-specific TMF Plan
  • Identify any corrective actions which must be addressed and assigned
  • Support the submission of documented evidence of the TMF Quality Review to the TMF
  • Support the management of TMF documentation issues throughout the lifecycle of an assigned study
  • Participate in the implementation of standards and processes for DevSci records management to verify compliance with relevant regulations
  • Support and carry out the processes associated with the storing, archiving, indexing, scanning and classifying records
  • Process records (e.g., track, scan, archive) in compliance with DevSci Records SOPs
  • Prepare and maintain manuals, training materials, policies and procedures and other quality documents as they apply to the management of records in DevSci Records
  • Provide guidance on best practices for record handling, retrieval and archival procedures
  • Provide archived DevSci records to users (e.g. internal staff and/or Auditors) for review
  • Oversee the provision of the required documents at the time of Regulatory Authority Inspection or internal Audits
  • Respond to TMF and non-TMF internal and/or external information inquiries related to DevSci records
    Systems Development
  • Participate in the development, implementation, and maintenance of classification and filing systems per administrative, research, regulatory, legal and financial requirements
  • Manage the off-site storage of DevSci records and the contract with the storage vendor, including vendor oversight
  • Participate in the development, implementation, and maintenance of internal databases used to manage records
Qualification/Education:
  • BA/BS in life sciences or technical area; experience in lieu of education may be considered
  • 2+ years of relevant pharmaceutical industry experience
  • Demonstrate foundational technical skills in Regulations and Good Practices, as well as Quality Management
Preferred Skills/Experience:
  • Relevant certification, such as Registered Quality Assurance Professional, Certified Quality Auditor, CCRA or CCRC, Certified Clinical Research Professional, or Regulatory Affairs Certification
  • Understanding of key regulatory agencies and regulatory inspection processes
  • Understanding of the objectives/purpose and key milestones/filings of each drug development phase (Pre-Clinical, phases I-IV)
  • Understanding of GxP principles, their importance, and how they apply to operational activities currently being performed
 
*Those authorized to work in the U.S. are encouraged to apply / Unable to Process H1B visa at this time / Unable to work on a C2C basis for this role* 

Job Requirements

 
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