Senior Associate I, TMF Operations - fixed-term - Europe - Home-based

Multiple Locations: Poland • England, UK • Serbia • Croatia • Romania

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Requisition Number: 7712

Position Title: Senior Associate I, TMF Operations

External Description:

Who we are

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 you will do

  • Perform RMC Lead Activities for 1-3 Studies.
  • 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.
  • Prepare, maintain, and share TMF metrics and spreadsheets for assigned studies with Project Teams and Sponsors. Review TMF Key Performance Indicators (KPIs) and makes sure that TMF KPIs are in compliance.
  • 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
  • Strong interpersonal skills
  • Ability to 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 )
  • 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.

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Employment Type: Fixed Term

Community / Marketing Title: Senior Associate I, TMF Operations - fixed-term - Europe - Home-based

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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 Worldwide Clinical Trials does not accept unsolicited resumes from 3rd party vendors

© Worldwide Clinical Trials 2023

We only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from employment agencies will not be considered and Worldwide is not responsible for any fees related to unsolicited resumes.