At a Glance
- Tasks: Manage complex studies and ensure compliance in TMF Operations.
- Company: Join a global CRO dedicated to innovative clinical research.
- Benefits: Remote work, diverse culture, and opportunities for professional growth.
- Other info: Dynamic environment with a focus on collaboration and creativity.
- Why this job: Make a real impact on patients' lives while working with a supportive team.
- Qualifications: 2-4 years of relevant experience and strong communication skills.
The predicted salary is between 34650 - 42350 £ per year.
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.
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.
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 2-4 years of relevant experience.
- Knowledge of working within a highly regulated industry or experience of CRO/Pharmaceutical Company industry.
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.
Senior Associate II, TMF Operations - EMEA/LATAM- Fixed term- Remote employer: Worldwide
At Worldwide Clinical Trials, we pride ourselves on being an exceptional employer that fosters a culture of innovation and collaboration. Our remote work model allows for flexibility while our commitment to diversity and inclusion ensures that every team member can thrive and contribute meaningfully to our mission of improving lives. With ample opportunities for professional growth and a supportive environment, we empower our employees to take charge of their careers and make a real impact in the clinical research field.
