Senior Associate I, TMF Operations

at  Worldwide Clinical Trials

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.

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.

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
  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 https://www.worldwide.com/ or connect with us on LinkedIn.
  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

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