Senior Associate II, Trial Master File (TMF) Operations (LATAM/Remote)

Requisition Number: 6221

Position Title: Senior Associate II, TMF Operations

External Description:

Who we are 

Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.

Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.   

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What the Senior Associate II does at Worldwide 

The Senior Associate II, 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 practice. The Senior Associate II will support the delivery of department objectives in ensuring the management essential documents. This is a global role and will require working with Worldwide Project Team members and Quality Assurance. 

What you will do 

• Perform RMC Lead Activities for 3-7 Studies, manage complex studies or Sponsor portfolio of studies 
• Deputize for RMC Oversight where required 
• Support TMF set-up, coordinate ‘Requests for Sites to be added in eTMF’ between Project. Teams (PT) and eTMF administrators; review eTMF access and coordinate updates as necessary. Provide Subject Matter Expert (SME) support for Project Teams and Sponsor 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. 
• 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. 

What you will bring to the role 

• Excellent written and verbal communication skills to clearly and concisely present information to internal and external parties. 
• Ability to exercise sound judgment and ability to identify decisions. 
• Proficiency in Microsoft Word and Excel 
• Leadership skills 

Your experience 

• University Degree preferred (Life Science desirable)   
• Combination of education plus 2-4 years of relevant experience 
• Knowledge of working within a highly regulated industry or experience of CRO/Pharmaceutical Company industry  

Why Worldwide 

We love knowing that someone is going to have a better life because of the work we do. 

To view our other roles, check out our careers page at www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

 

 

 

 

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Employment Type: Regular

Community / Marketing Title: Senior Associate II, Trial Master File (TMF) Operations (LATAM/Remote)

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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