Senior Associate I, TMF Operations (LATAM/Remote)

Requisition Number: 7028

Position Title: Senior Associate I, 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 I does at Worldwide  

The Senior Associate I, 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 I 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.
• Maintain Sciforma resources and tasks up to date.
• Communicate directly with multiple Project Team members and Sponsors to assess project needs relevant to the TMF.
• Provide Subject Matter Expert (SME) support for Project Teams and Sponsor related to TMF. Prepare, maintain, and share TMF metrics and spreadsheets for assigned studies with Project Teams and Sponsors.
• Oversee the QC process and makes sure the RMC is on track (compliant with timelines and documentation) and follow up on non-compliance accordingly.

What You Will Bring To The Role

• Excellent written and verbal communication skills to clearly and concisely present information to internal and external parties
• Strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment
• Ability to deliver advise to Project Team members on key TMF issues
• Demonstrated strong planning and organizational 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 I, 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.

Location_formattedLocationLong: Mexican Federal District, MX

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