Aktuelle Jobs im Zusammenhang mit Sponsor Dedicated Start up Specialist based in Germany - München - Fortrea
-
Sponsor-dedicated Cra Germany
vor 1 Woche
München, Deutschland Syneos - Clinical and Corporate - Prod Vollzeit**Description** Sponsor-dedicated CRA Germany Syneos Health® is a leading fully 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. Our Clinical Development model brings the customer and the patient...
-
München, Deutschland Fortrea VollzeitMake a meaningful impact in clinical research by joining our sponsor-dedicated team as a **Clinical Research Associate (CRA)**. This role offers the opportunity to monitor regionally around **Cologne, Heidelberg, or Frankfurt**, while working on cutting-edge studies that shape the future of healthcare. **Key Responsibilities**: - Identify and assess new...
-
Clinical Scientist
Vor 2 Tagen
München, Deutschland Syneos - Clinical and Corporate - Prod Vollzeit**Description** Clinical Scientist (EMEA, NA, LATAM) - Sponsor - dedicated Syneos Health® is a leading fully 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. Our Clinical Development model brings...
-
Internship Program Germany- 2025
Vor 6 Tagen
München, Deutschland Fortrea VollzeitAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development and technology solutions across more than 20 therapeutic areas. With over 18,000 staff conducting...
-
Developer Community Programs Specialist, Germany
Vor 2 Tagen
München, Deutschland Grafana Labs VollzeitCommunity and open-source software are at the heart of everything we do at Grafana Labs. As a Developer Community Programs Specialist, you will support our team’s engagement with the open-source and developer communities. In this role, you will help implement and execute programs that empower community members to be successful with Grafana Labs projects....
-
Senior) Payroll Support Specialist
vor 2 Wochen
München, Deutschland Personio SE & Co. KG Vollzeit**Payroll Sales & Operations** - Full Time - Munich, Berlin, Dublin, Amsterdam, London, Remote Germany - Personio's intelligent HR platform helps small and medium-sized organizations unlock the power of people by making complicated, time-consuming tasks simple and efficient. Our growing team of 1,800+ Personios across Europe and the US are building...
-
Associate Director
vor 2 Wochen
München, Deutschland UniCredit bank Vollzeit**Allgemeine Informationen**: - Job Id - 34495 - Unternehmen - HypoVereinsbank - UniCredit Bank GmbH - Competence Line - Client Solutions - Funktionsbereich - Investment Banking Products - Standort - München - Land - Deutschland - Kontakt - Besetzungsdatum - 01.05.2025 - Jobniveau - Professional - Vertragsart - Unbefristet - Arbeitszeitmodell -...
-
Specialist Cyber Insurance
vor 2 Wochen
München, Deutschland Zync Group VollzeitI am proud to be partnered with a forward-thinking technology company dedicated to delivering innovative solutions in cybersecurity and IT services. With a strong commitment to excellence and customer satisfaction, they are hiring for a Cyber Risk Sales Specialist to help grow their network and footprint throughout Germany. With modern offices and colleagues...
-
Single Sponsor Senior Clinical Medical Writer
Vor 2 Tagen
München, Deutschland Syneos - Clinical and Corporate - Prod Vollzeit**Description** Single Sponsor Senior Clinical Medical Writer - (fully home based) 6 month FTC Syneos Health® is a leading fully 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. Our Clinical...
-
Qm Associate
Vor 6 Tagen
München, Deutschland Brainlab Vollzeit**Company Description** Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2400 dedicated and inspiring individuals in 25...
Sponsor Dedicated Start up Specialist based in Germany
vor 2 Wochen
Join Our Team and Drive Clinical Research Success
At Fortrea, we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist, you will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed efficiently. Your expertise will help bring life-changing treatments to patients faster.
In this role, you will be part of our FSPx team and work directly with one of our renowned key sponsor to advance the development of innovative, life-changing medications.
Key Responsibilities:
In this role, you will:
- Serve as the primary contact for investigative sites during start-up and maintenance activities.
- Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority).
- Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.
- Prepare and submit regulatory documents, including country-specific application forms and informed consent forms.
- Track submission timelines and proactively address potential delays.
- Collaborate with internal and external stakeholders, including vendors, clinical teams, and regulatory authorities.
- Ensure all documentation is audit-ready and systems are consistently updated.
- Assist in the negotiation of site contracts and budgets, if applicable.
- Provide mentorship and training to new hires and less-experienced colleagues.
Required Qualifications:
To succeed in this role, you should have:
- University/College degree (life sciences preferred) or certification in a related allied health profession.
- Minimum 2 years of experience in clinical research, regulatory submissions, or site activation.
- Strong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes.
- Ability to review and adapt patient informed consent forms to meet local and protocol-specific requirements.
- Experience interacting with regulatory authorities and site start-up teams.
- Excellent organizational, problem-solving, and communication skills.
- Proficiency in Microsoft Office and document management systems.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Fluency in German and English
What We Offer:
- Competitive salary and performance-based incentives.
- Flexible work arrangements (remote/hybrid options).
- Professional growth opportunities in a collaborative and innovative environment.
- The opportunity to work on cutting-edge clinical research projects.
Ready to Make an Impact?
Join us in shaping the future of clinical research. Apply today
Applications are reviewed on a rolling basis—don't miss this opportunity
LI-GQ1 #RemoteLearn more about our EEO & Accommodations request here.
