Kn678 Senior Associate Ii, Tmf Operations - Europe - Home Based

Senior Associate II, TMF Operations - Europe - Home based
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. 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 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 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.

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 ensure the RMC is on track (compliant with timelines).

What you will bring to the role Data collection, indexing, and editing skills, including the 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.

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