Senior Associate I, TMF Operations

Worldwide Clinical Trials; Brasil; Presencial; BRL 120 000 - 180 000; Tempo integral

Resumo da oferta

Worldwide Clinical Trials in Brazil is seeking a TMF Operations professional to manage trial master file processes and ensure regulatory compliance across studies.

You will collaborate with project teams, sponsor contacts and QA to maintain quality, generate KPIs, and support audits. A life sciences degree and 1–3 years in a regulated CRO environment are preferred.

Qualificações

• Proficient understanding of clinical research principles, industry standards and TMF regulations.
• Strong planning and organizational skills under pressure.
• Excellent written and verbal communication to internal and external parties.
• Ability to identify regulatory compliant solutions for complex situations.
• Experience in regulated CRO/pharma environment.

Responsabilidades

• Perform RMC Lead Activities, managing studies or Sponsor portfolio.
• Communicate with Project Team members and Sponsors to assess TMF needs.
• Oversee Quality Control, planning and non-compliance follow-up.
• Develop project-specific TMF Quality Management Documents.
• Prepare and present TMF KPIs and data trends to teams.
• Support Regulatory and Sponsor audits and audit findings resolution.

Conhecimentos

TMF management knowledge

Regulatory compliance

Planning & organization

Interpersonal communication

Problem solving

Attention to detail

Formação académica

University degree (Life Science desirable)

1-3 years relevant experience

Descrição da oferta de emprego

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.

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 records in strict accordance with pertinent Standard Operating Procedures, 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

• Perform RMC Lead Activities, managing a number of complex studies or Sponsor portfolio of studies.
• Communicate directly with multiple Project Team members and Sponsors to assess project needs relevant to the TMF and to provide Subject Matter Expertise (SME).
• Oversee the Quality Control process including planning, reporting and follow up on non-compliance accordingly.
• Assist in development of project specific TMF Quality Management Documents.
• Prepare, maintain, and present TMF Key Performance Indicators and underlying data analysis trends with Project Teams and Sponsors.
• Support Regulatory and Sponsor audits and audit finding resolution, where necessary.

What You Will Bring To The Role

• Proficient understanding of clinical research principles, industry standards and regulations applicable to TMF Management
• Demonstrate strong planning and organizational skills with ability to work under pressure
• Display strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment
• Possess excellent written and verbal communication skills to clearly and concisely present information to internal and external parties
• Ability to identify solutions and make decisions or have awareness to consult to find optimal regulatory compliant solutions including those required for complex technical situations.

Your Experience

• University degree preferred (Life Science desirable)
• A 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

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

We love knowing that someone is going to have a better life because of the work we do.

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.