Senior Associate II – TMF Operations, EMEA/LATAM

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• 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.

🎯 Requirements

• 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. • 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

🏖️ Benefits

• culture of collaboration and innovation • diverse and inclusive environment • professional development