Study Monitor for Nonclinical Safety Studies / Outsourcing Manager

The Position

Join a highly impactful role at the interface of science, outsourcing strategy, and global collaboration, where you will drive the successful delivery of nonclinical safety studies with external partners. As Study Monitor for Nonclinical Safety Studies / Outsourcing Manager, you will play a key role in ensuring high-quality, compliant study execution while shaping partnerships with international CROs. This position offers a unique opportunity to combine scientific expertise with strategic oversight in a dynamic, cross-functional environment.

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This position is part time eligible with 80 %.

Tasks & responsibilities

  • You lead the outsourcing and monitoring of external nonclinical safety studies (general toxicology, safety pharmacology), ensuring timely and fit-for-purpose delivery for Global Non-clinical Safety Science (NCS).
  • As the Sponsor’s Study Monitor, you oversee end-to-end study execution, aligning CRO performance with internal expectations and managing scope, milestones, and risks.
  • In close collaboration with cross-functional teams, you coordinate the review and approval of study protocols, amendments, and final reports (administrative, logistical, and scientific inputs) and in addition to the Scientific Monitor ensure the scientific soundness of the studies.
  • You ensure full GLP compliance and inspection readiness by establishing clear communication channels, defined roles, and complete documentation with CROs and facility management.
  • Driving planning activities, you coordinate study schedules, resources, and portfolio priorities while proactively identifying capacity constraints and keeping stakeholders informed.
  • Additionally, as a Study Monitor you monitor the animal welfare aspects during the studies.
  • Acting as a key interface, you manage communication with CROs and internal partners, contribute to budget oversight, and support governance processes and outsourcing strategy implementation.

Requirements

  • Degree (Ph.D. preferred) in biology, toxicology, veterinary medicine, or a related field – substitutable by relevant practical work experience; postgraduate qualification in toxicology considered an advantage
  • Proven experience in nonclinical safety studies (general toxicology, safety pharmacology), ideally within a GLP-regulated environment and/or as Study Director or Principal Investigator
  • Strong understanding of nonclinical study design, regulatory requirements, and quality standards supporting drug development and submissions
  • Excellent organizational, coordination, and problem-solving skills with the ability to manage multiple priorities under time pressure
  • Strong communication skills in English (written and spoken) and ability to collaborate effectively in global, cross-functional teams
  • Structured, independent, and flexible working style, combined with intercultural competence and willingness to travel

As part of our commitment to transparency and fairness, salary information will be shared during the recruitment process. We also offer a comprehensive benefits and wellbeing package.

Applications from persons with severe disabilities are warmly welcomed. In cases of equal qualifications, such applicants will be given preferential consideration in the selection process. 

Ready to contact us?

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or via mail: hr.de@boehringer-ingelheim.com

Recruitment process:
Step 1: Online application - The job posting will be online until June 20, 2026. We reserve the right to take the posting offline beforehand. Applications up to June 16, 2026 are guaranteed to be considered.
Step 2: Virtual meeting - at the end of June to the beginning of July.
Step 3: On-site interviews – starting at the end of July.