Associate Manager, TMF Operations (Mexico)

Requisition Number: 6126

Position Title: Associate Manager, TMF Operations

External Description:

Who we are 

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. 

 

We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. 

 

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.  

What you will do as an Associate Manager, TMF Operations

The Associate Manager, of TMF Operations is responsible for that TMF is set up, maintained, finalized, “returned” to the Sponsors, and archived in compliance with relevant Standard Operational Procedures, country regulations, and industry best practices.

The Associate Manager, of TMF Operations is responsible for supporting the implementation of process improvement initiatives related to TMF Operations and establishing governance within the department. This is a global role and will require working with Worldwide Project Team members, Quality Assurance, Worldwide Records Management Compliance Team responsible for Quality, System and Training tasks, Sponsors, 3rd Party CROs, Regulatory agencies, and Worldwide Senior Leadership.
The Associate Manager, TMF Operations provides leadership and direction for his/her direct reports.
 
RESPONSIBILITIES:
Tasks may include but are not limited to:

• Perform the role of the "TMF Process Owner" as necessary
• Deputize as Designated Archivist as necessary
• Deputies for Senior TMF Operational Management where required
• Perform RMC Oversight Activities where required
• Execute Financial Oversight
• Plan Resource utilization
• Oversee that the Project Management tool is up to date
• Responsible for TMF Operational management by supporting the negotiation of clear objectives and targets with Sponsor, Worldwide Therapeutic Area Leads, and Worldwide Functional Leads
• Organize and/or Oversee TMF set up, maintenance, finalization, “return” to the Sponsors, and archiving
• Organize and/or Oversee the QC process and makes sure that the QC is ongoing in compliance with Project Specific TMF Management Plans
• Organize and/or Support TMF Final Reconciliation and lead related communication with Worldwide Global Project Lead and Sponsor
• Ensure TMF Compliance Milestones are adhered to during the entire study
• Ensure the key TMF documents (i.e. SIRAF, TMF Plan, Annotated TMF Structure, QC Certificates) are generated and filed in compliance with a relevant Standard Operational Procedures
• Suggest and support Process Improvement related to TMF
• Manage/Mentor junior team members responsible for operations (Team Leads where possible)
• Monitor team progress on goals and objectives quarterly
• Provide support in identifying key risks and risk mitigation 
• Assist in the development of TMF Quality Management Document Templates
• Develop or oversee that Project Specific TMF Quality Management Documents are developed in compliance with relevant Standard Operational Procedures
• Contribute to Company QMD development to make sure that items related to TMF are up to date and in line with Regulatory, ICH GCP, and Industry standards
• Work closely with Functional Leads to support TMF process improvement in the Company where needed
• Work closely with TMF Quality Team and communicate TMF issues and non-compliance 
• Support TMF Audits and Inspections and resolution of Audit/Inspection findings and management of any corrective and preventative actions
• Support Training organized by RMC Training Team
• Serve as subject matter expert on TMF aspects and TMF processes
• Support implementation and Monitor TMF quality metrics, Key Performance Indicators, and Quality Threshold Limits related to quality, timeliness, and TMF completeness to minimalize any potential Audit and Inspection findings
• Support Internal and External Teams where needed
• Communicate trends and training needs that require training support
• Provide leadership and support in promoting TMF Compliance and continual Inspection readiness
• Support Escalation Process and attend Project Specific calls if there are issues and escalations
• Escalate issues and lead the implementation of solutions, corrective, and preventative actions
• Attend Relevant Meetings (i.e Portfolio Level calls, TMF Specific calls, Sponsor JOC and Governance, Lunch Meetings)
• Ensure that trial documentation is stored by relevant guidelines and requirements of both Worldwide and Sponsor companies
• 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:

• Line management of staff or ability 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 and implement decisions within limited supervisory approval
• Able to work independently and with limited support from the line manager
• Able to identify roadblocks to a deliverable completion and effectively brings them to line managers for resolution
• Handle multiple, highly detailed tasks with exceptional accuracy and excellent attention to detail
• Develops solutions to technical problems of moderate complexity
• Demonstrate strong planning and organizational skills
• Develop proficiency in the use of an electronic document repository or eTMF Solutions
• Understanding and adherence to corresponding Worldwide and sponsor standard operating procedures
• General understanding of clinical research principles and processes
• Excellent oral and written communication skills
• Strategic thinker capable of identifying decisions requiring escalation or management approval when necessary
• Planning and organizational skills with effective time management
• Able to interpret data in a logical and precise manner
• Working knowledge of FDA and EU Directives and regulations, ICH Guidelines, and local regulatory requirements
• In the role of RMC Oversight manage complex studies or Sponsor portfolio of studies

REQUIREMENTS:

• Associate Degree (Science preferred) plus 3-6 years relevant experience or
• Equivalent work experience (5-8 years) instead of an Associate Degree
• Bachelor’s Degree (Science preferred) plus 2-4 years relevant experience or
• Equivalent work experience (4-7 years) instead of an Bachelor’s degree

and

• In-depth knowledge of ICH GCP
• Experience supporting GCP inspections (e.g., FDA, PMDA, EMA, Bfarm, MHRA, etc.)
• Experience in 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
• Domestic and international travel required (approximately 10-30%

 

Why Worldwide 
 

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.   

 

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers! 

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Employment Type: Regular

Community / Marketing Title: Associate Manager, TMF Operations (Mexico)

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.

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