Clinical Studies Specialist (m/f/d)

Your satisfaction is at the center of our actions.

For over 30 years, Herrmann Personaldienste GmbH has specialized in the recruitment and placement of specialist personnel from the industrial and craft sectors.

Take advantage of our excellent contacts to industrial corporations and renowned medium-sized craft companies. We guarantee you competent and personal support as well as attractive conditions in our company.

OUR CUSTOMER

Our customer is a globally active biopharmaceutical company with a significant German location in Monheim am Rhein. The focus is on the research and development of innovative medicines and treatment options for people with serious illnesses. Scientific expertise, internationally networked structures, and high requirements for quality and responsible action characterize the company's activities.

At the Monheim location, central tasks of clinical development are located, among others. Here, clinical studies are accompanied from conception through data analysis to final reporting. Look forward to a demanding activity in a regulated working environment, clearly organized processes, and collaboration with various national and international departments.

WE OFFER YOU

• Attractive remuneration, aligned with your qualifications and previous professional experience
• Option, by arrangement, to work in the home office up to two days per week
• Responsible activity in the area of transparency and publication of clinical studies
• Collaboration with an internationally positioned team and various departments of clinical development
• Comprehensive induction into internal company processes, systems, and regulatory requirements
• Vacation and Christmas bonuses according to the applicable collective agreements
• Up to 30 vacation days per year as well as the possibility to take vacation even during the probationary period
• Personal care and individual support through fixed contact persons throughout the entire assignment
• Exclusive employee benefits via Corporate Benefits with discounts at numerous well-known brands and online shops
• Bonuses within the framework of our employee-refer-employee program

YOUR TASKS

• You develop the strategy for the registration of clinical studies and the publication of the associated study information and results
• You take the resulting transparency requirements into account already during the study conception, the creation of the study protocol, and later protocol amendments
• You carefully prepare all required information for global and regional study registries, check them for content, and submit them on time
• You keep the associated registry entries complete, correct, and up to date throughout the entire course of the study
• You coordinate the timely publication of study results and ensure compliance with regulatory and internal company specifications
• In daily business, you coordinate closely with Clinical Project Management, Biostatistics, Medical Writing, Regulatory Affairs, Patient Safety, Intellectual Property, and other specialist departments
• You reliably coordinate external service providers and monitor the agreed services, deadlines, and quality requirements
• In the case of complex issues or deviations from the intended processes, you coordinate further action with the responsible experts
• You document all registration and publication steps without gaps and provide the necessary evidence for internal and regulatory audits
• Furthermore, you contribute to ensuring data quality and the proper maintenance of the systems used

YOUR PROFILE

• You have successfully completed a university degree in Life Sciences, Natural Sciences, or a related field at least at Bachelor level
• You already have professional experience in clinical research, clinical study management, or a regulatory-oriented field of activity
• You are very familiar with the regulatory requirements for the registration of clinical studies and the publication of study information and results
• Ideally, you have already worked with international study registries and maintained and updated the study data contained therein
• You understand the processes during the entire lifecycle of a clinical study and know the associated professional interfaces
• Your very good English skills enable you to collaborate securely in writing and orally within an international team
• You communicate clearly and bindingly and coordinate confidently with different specialist departments and external service providers
• A careful, structured, and quality-conscious way of working characterizes you
• Even with several parallel processes, you reliably keep regulatory deadlines and necessary coordinations in view
• Initiative, sense of responsibility, and enjoyment of teamwork round off your profile

TO YOUR NEW JOB IN ONLY 2 MINUTES

Simply use our online form and upload your complete application documents (including an informative CV, references, certificates, etc.) – a cover letter is not required.

For questions, your personal contact persons in our company are happy to assist you in advance.

We look forward to meeting you!

IMPORTANT NOTE

A work permit for Germany is mandatory to perform this activity. We politely ask for your understanding that otherwise your application will not be considered