TMF Training Manager - Europe - Home Based
* SUMMARY: The Manager, TMF Operations is responsible for the processing, maintaining and archiving of all essential documents in compliance with the relevant Standard Operating Procedures, country regulations and industry best practice. The Manager will assist to guide the strategy and lead the delivery of department objectives in ensuring the management of the essential documents. *
* This is a global role and will require working with Worldwide Project Team members, Sponsors, 3rd Party CROs, regulatory agencies and Quality Assurance. *
* RESPONSIBILITIES: *
* Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles as defined by the relevant Standard Operation Procedure(s) (SOP)
* Perform role of the "TMF Process Owner"
* Deputize as Designated Archivist as necessary
* Will act as "RMC Lead" on a number of Project Teams
* Serve as subject matter expert on Records Management Compliance processes
* Ability to identify roadblocks to a deliverable completion and effectively brings them to line managers for resolution
* Process Trial Master File (TMF) documents for multiple studies both in an electronic and hard copy format
* Prepare periodic TMF Quality Control checklists for review by Project Team review
* Maintenance of TMF metrics and spreadsheets for assigned studies
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices
* Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents
* Ensure TMF Compliance Milestones are adhered to during the entire study
* Provide input into departmental resourcing requirements
* Communicate directly with multiple Project Team members to assess project needs relevant to the TMF
* Provide regular updates on TMF Compliance to Project Teams and Sponsors as necessary
* Act as a mentor to junior members of the team
* Prepare and transmit TMF and other critical documents to the Sponsor in accordance with the relevant instructions
* Review SOPs and supporting documents for compliance with relevant SOP, legislation, and industry best practice
* Lead TMF activities during regulatory inspections and Sponsor audits
* Provide leadership in promoting TMF Compliance and continual Inspection readiness
* Escalate issues and lead the implementation of solutions, corrective and preventative actions
* OTHER SKILLS AND ABILITIES: *
* Line management of staff or able to influence key personnel via a matrix organization
* Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
* Able to demonstrate resource management capabilities
* Manage within a budget
* Display strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing
* environment
* Exercise sound judgment and ability to identify decisions requiring supervisory approval
* Handle multiple, highly detailed tasks with exceptional accuracy
* Develops solutions to technical problems of moderate complexity
* Deliver advise to Project Team members on key TMF issues
* Demonstrate strong planning and organizational skills
* Demonstrate proficiency in Microsoft Word and Excel
* Develop proficiency in use of an electronic document repository
* Understanding and adherence to corresponding Worldwide and sponsor standard operating
* procedures
* General understanding of clinical research principles and processes
* REQUIREMENTS: *
* Associate Degree (Science preferred) plus 5-8 years relevant experience or
* Bachelor's Degree (Science preferred) plus 3-6 years relevant experience or
* Combination of education plus 5-8 years of relevant experience
* In depth knowledge of ICH GCP
* Experience in supporting GCP inspections (e.g., FDA, PMDA, EMA, Bfarm, MHRA, etc.)
* Experience of Document Management and/or eTMF solutions (e.g. Veeva, Trial Interactive, Documentum, etc.)
* Working knowledge of working within highly regulated industries (desirable)
* This is a global role and will require working with Worldwide Project Team members, Sponsors, 3rd Party CROs, regulatory agencies and Quality Assurance. *
* RESPONSIBILITIES: *
* Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles as defined by the relevant Standard Operation Procedure(s) (SOP)
* Perform role of the "TMF Process Owner"
* Deputize as Designated Archivist as necessary
* Will act as "RMC Lead" on a number of Project Teams
* Serve as subject matter expert on Records Management Compliance processes
* Ability to identify roadblocks to a deliverable completion and effectively brings them to line managers for resolution
* Process Trial Master File (TMF) documents for multiple studies both in an electronic and hard copy format
* Prepare periodic TMF Quality Control checklists for review by Project Team review
* Maintenance of TMF metrics and spreadsheets for assigned studies
* Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices
* Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents
* Ensure TMF Compliance Milestones are adhered to during the entire study
* Provide input into departmental resourcing requirements
* Communicate directly with multiple Project Team members to assess project needs relevant to the TMF
* Provide regular updates on TMF Compliance to Project Teams and Sponsors as necessary
* Act as a mentor to junior members of the team
* Prepare and transmit TMF and other critical documents to the Sponsor in accordance with the relevant instructions
* Review SOPs and supporting documents for compliance with relevant SOP, legislation, and industry best practice
* Lead TMF activities during regulatory inspections and Sponsor audits
* Provide leadership in promoting TMF Compliance and continual Inspection readiness
* Escalate issues and lead the implementation of solutions, corrective and preventative actions
* OTHER SKILLS AND ABILITIES: *
* Line management of staff or able to influence key personnel via a matrix organization
* Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
* Able to demonstrate resource management capabilities
* Manage within a budget
* Display strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing
* environment
* Exercise sound judgment and ability to identify decisions requiring supervisory approval
* Handle multiple, highly detailed tasks with exceptional accuracy
* Develops solutions to technical problems of moderate complexity
* Deliver advise to Project Team members on key TMF issues
* Demonstrate strong planning and organizational skills
* Demonstrate proficiency in Microsoft Word and Excel
* Develop proficiency in use of an electronic document repository
* Understanding and adherence to corresponding Worldwide and sponsor standard operating
* procedures
* General understanding of clinical research principles and processes
* REQUIREMENTS: *
* Associate Degree (Science preferred) plus 5-8 years relevant experience or
* Bachelor's Degree (Science preferred) plus 3-6 years relevant experience or
* Combination of education plus 5-8 years of relevant experience
* In depth knowledge of ICH GCP
* Experience in supporting GCP inspections (e.g., FDA, PMDA, EMA, Bfarm, MHRA, etc.)
* Experience of Document Management and/or eTMF solutions (e.g. Veeva, Trial Interactive, Documentum, etc.)
* Working knowledge of working within highly regulated industries (desirable)