Senior Manager, TMF Operations

Location: North Carolina, United States

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Requisition Number: 1215

Position Title: Manager, TMF Operations

External Description:

Worldwide Clinical Trials is seeking Manager/Senior Manager or Associate Director, TMF Operations to join our team!

This role can be based in the US or Europe.

The Senior Manager 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 Senior Manager will assist to guide the strategy and lead the delivery of department objectives in ensuring the management of the essential documents.  They will assist the Department Head in implementing the strategic objectives. This is a global role and will require working with Worldwide Project Team members, Sponsors, the 3rd Party CROs, regulatory agencies, Worldwide Senior Leadership and Quality Assurance.
 
RESPONSIBILITIES:
 
Tasks may include but are not limited to:

  • 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 with limited input from line managers
  • 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
  • Lead resourcing requirements within the department using appropriate project management tools/systems
  • Have good understanding of all other roles within Records Management Compliance
  • 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
  • Review and create 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
  • Provide regular updates on the TMF Programme direct to Sponsors
  • Develop, then implement strategic solutions to good TMF Management
  • Line Management of Senior roles/Managers

 Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
                                                                                                                                                            
 
OTHER SKILLS AND ABILITIES: 

  • People management, 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 and implement decisions within limited supervisory approval
  • Handle multiple, highly detailed tasks with exceptional accuracy
  • Develops solutions to technical problems of high 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
  • Strategic thinker with experience in change management
  • In depth understanding of clinical research principles and processes

 
REQUIREMENTS:

  • Associate Degree (Science preferred) plus 6-9 years relevant experience or
  • Bachelor’s Degree (Science preferred) plus 4-7 years relevant experience or
  • Combination of education plus 8-11 years of relevant experience
  • In depth knowledge of ICH GCP
  • Experience 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)
  • Ability to provide compliance and quality oversight of TMF processes 

#LI-HD1

City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Senior Manager, TMF Operations

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Morrisville, North Carolina US

CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.

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