Covance is searching for the Study Start Up Specialist II to be preferebly located in Munich office based. Candidates from other European countries with fluent or good German language skills are also very welcome.
Primary contact with more challenging sites or those hosting complex studies. The jobholder, working in a cross functional team, facilitates delivery of the site start-up (SSU) component of assigned studies within a country, including full accountability for delivery to time, cost and quality for assigned activities with minimal supervision.
The jobholder operates within the boundaries of assigned budget, provides guidance to internal and site staff around process and other operational issues. Submits regular reports to Start-up Country Manager (SUCM) and project team regarding progress and challenges.
Develops and implements strategies for the earliest possible approval of regulatory submission by reducing the hours allocated to activate sites, maximizing the time for patient enrolment and actively seeking local efficiencies within global processes.
Essential Job Duties:
University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 4 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered
Minimum of 4 years of experience in clinical development or regulatory process.
Significant experience of applying strong knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites Significant experience of issue escalation and resolution.
Proven track record of effective communication and problem solving.
Experienced in creating and maintaining good business relationships
Proven ability to work under pressure with multiple internal clients with competing goals