Senior Associate II, TMF Operations

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

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 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 

• 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 to assess project needs relevant to the TMF. 
• 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

What you will bring to the role 

• Data collection, indexing and editing skills, including ability to adhere to standardized document naming conventions 
• Excellent written and verbal communication skills to clearly and concisely present Information to internal and external parties 
• Ability to work independently and with teams (internal and external) and handle multiple, highly detailed tasks with exceptional accuracy 
• Strong planning and organizational skills 

• Proficiency in Microsoft Word and Excel

Your experience 

• 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 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.