[Hiring] Senior Associate II, TMF Operations @Worldwide Clinical Trials

Role 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.

Qualifications

• 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.

Requirements

• 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

• 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.