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Senior Associate II, TMF Operations

Remote: 
Full Remote
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

University Degree preferred, 2-4 years of relevant experience, Knowledge of regulated industry, Proficiency in Microsoft Word and Excel.

Key responsabilities:

  • Support TMF set-up and coordination
  • Oversee QC process and compliance
Worldwide Clinical Trials logo
Worldwide Clinical Trials Large http://www.worldwide.com
1001 - 5000 Employees
See more Worldwide Clinical Trials offers

Job description

Who We Are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

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 Records Management Compliance Department Does At Worldwide

TMF Operations handles the processing, maintenance and archiving of all essential documents in strict accordance with pertinent Standard Operating Procedures, country-specific regulations, and industry best practices. Throughout Worldwide Clinical Trials, our culture of collaboration and innovation is what propels us in our pursuit of excellence in clinical research and making a meaningful impact on every patient's life. Roles within our TMF Operations department have a global scope, with the opportunity to regularly collaborate with members of the Worldwide Project Team.

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 2-4 years of relevant experience
  • Knowledge of working within a highly regulated industry or experience of CRO/Pharmaceutical Company industry

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 Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Teamwork
  • Planning
  • Communication
  • Organizational Skills

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