Sr CRA, Oncology, FSP, home based, client dedicated

Sr CRA, Oncology, FSP, home based, client dedicated

Updated: December 5, 2024
Location: Europe-Germany
Job ID: 24006587

Sr Clinical Research Associate, Germany home-based, sponsor dedicated, perm

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world.

Here at Syneos Health we are currently recruiting for a Clinical Research Associate opening to work on a sponsor-dedicated role in Germany. Based on your experience, we have the flexibility to adjust the role to the level of the successful candidate. This role is part of our FSP 360 team (functional service provider), which is designed to successfully meet the individual needs and goals of the client you will be supporting.

Your responsibilities:

1. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
2. Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
3. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
4. Gains an in-depth understanding of the study protocol and related procedures.
5. Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
6. Participates & provides inputs on site selection and validation activities.
7. Performs remote and on-site monitoring & oversight activities using various tools to ensure:

1. Data generated at site are complete, accurate and unbiased
2. Subjects’ right, safety and well-being are protected

Qualifications

What we’re looking for:
• Min B.A./B.S. required with strong emphasis in science and/or biology coupled with relevant work experience
• Min. 2 years of direct site monitoring experience in Oncology, in a bio/pharma/CRO for CRA II level, and more accordingly for higher level (Sr CRA)
• Fluent in German and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands on knowledge of Good Documentation Practices
• Proven Skills in Site Management including management of site performance and patient recruitment
• Demonstrated high level of monitoring skill with independent professional judgment.
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
• Ability to understand and analyze data/metrics and act appropriately
• Willingness to perform an average of about 8 monitoring visits per month within Germany and you may get asked to cover the German part of Switzerland as well potentially from time to time.

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles.

Syneos Health is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against.

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