Senior Associate I - Mexico

Requisition Number: 6221

Position Title: Senior Associate I, 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, 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 a Senior Associate I, TMF Operations does at Worldwide Clinical Trials

The Senior Associate, TMF Operations is responsible for maintaining Trial Master Files inspection readiness in compliance with the relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices. The Senior Associate I will support the delivery of department objectives in ensuring the management of essential documents. This is a global role and will require working with Worldwide Project Team members and Quality Assurance. 

RESPONSIBILITIES: 
Tasks may include but are not limited to: 

• Perform RMC Lead Activities for 1-3 Studies. 
• Support TMF set-up, and coordinate ‘Requests for Sites to be added in eTMF’ between Projects. Teams (PT) and eTMF administrators; review eTMF access and coordinate updates, as necessary.  
• Maintain Sciforma resources and tasks up to date. 
• Communicate directly with multiple Project Team members to assess project needs relevant to the TMF. 
• Provide Subject Matter Expert (SME) support for Project Teams and sponsors related to TMF. 
• Oversee the QC process and makes sure the RMC is on track (compliant with timelines and documentation) and follow up on non-compliance accordingly. 
• Prepare, maintain, and share TMF metrics and spreadsheets with Project Teams and Sponsors for assigned studies. Review TMF Key Performance Indicators (KPIs) and makes sure that TMF KPIs are in compliance. 
• Follow-up, raise, and escalate any TMF Quality issues and non-compliances in a timely manner to relevant parties. 
• Support Regulatory and Sponsor audits and audits finding resolution, where necessary. 
• Attend Internal and External Project Meetings and provide updates to agendas and Minutes. 
• Maintain the Study SharePoint for the Records Management Compliance-related items and ensure documentation related to TMF Processes is filed accordingly. 
• Organize TMF dedicated Meetings. 
• Support the training organized by Records Management Compliance Training Team and act as a mentor to junior members of the team 
• Assist in the development of project-specific TMF Quality Management Documents 
• Support TMF Final Reconciliation and generation of Final List of queries 
• Support communication with Study Team and Sponsor related to TMF Final Reconciliation and TMF Closure and Return 
• If required: 
• Prepare periodic TMF Quality Control checklists for review by the Project Team review. 
• Fulfill the "TMF QC Reviewer" role as defined by the relevant Standard Operation Procedure(s) (SOP). 
• Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.  

OTHER SKILLS AND ABILITIES:  

• Possess data collection, indexing, and editing skills, including the ability to adhere to standardized document naming conventions 
• Possess excellent written and verbal communication skills to clearly and concisely present information to internal and external parties 
• Work independently and with teams (internal and external) and handle multiple, highly detailed tasks with exceptional accuracy 
• Ability to work under pressure 
• Display strong interpersonal skills in a fast-paced, deadline-oriented, rapidly changing environment 
• Exercise sound judgment and ability to identify decisions  
• Develops solutions to technical problems of high complexity 
• Deliver advice to Project Team members on key TMF issues 
• Demonstrate strong planning and organizational skills 
• Demonstrate proficiency in Microsoft Word and Excel 
• Deep understanding and adherence to corresponding Worldwide and sponsor standard operating procedures 
• Proficient understanding of clinical research principles and processes 

REQUIREMENTS: 

• University Degree preferred (Life Science desirable)   
• Combination of education plus 1-3 years of relevant experience 
• Knowledge of working within a highly regulated industry or experience in CRO/Pharmaceutical Company

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: Senior Associate I - 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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