Senior Cra

**Job Description Summary**:
**About the Role**

The Senior Clinical Research Associate (Sr. CRA) is responsible for activities associated with the preparation and execution of pre/-post-market clinical studies with BD medical devices. The Sr. CRA ensures that studies are performed in accordance with project timelines, company procedures and applicable regulations (EU MDR, CFR 21, ISO14155). Dedication to quality, attention to details, and excellent communication skills are essential to be successful in complex projects conducted by cross-functional BD teams and external partners.

**Key responsibilities**:

- Support site qualification and perform study initiation visits, including training of Investigators and Study Coordinators
- Perform regular Monitoring Visits at investigational sites ensuring patient safety and data integrity
- Ensure that clinical site staff complete tasks in accordance with study protocol and applicable national and international regulations
- Ensure proper documentation and timely reporting of adverse events and protocol deviations
- Active site management and collaboration with Project Managers, CRAs and vendors

Further responsibilities:

- Assist with development and maintenance of study-related documents and processes
- Assist with sponsor safety reporting, contracts and payments
- Develop sound knowledge about relevant disease states and BD products
- Train colleagues on BD SOPs and study-specific documentation
- Assist Project Managers with study submissions, team meetings and monitoring reports
- Assist with audits and inspections

**About You**:

- BSc/MSc/PhD in LifeSciences, Biomedical Engineering, Medicine or similar background
- 3 years of CRA experience managing investigational sites in an industry setting (sponsor, CRO)
- Knowledge of GCP/ISO14155 and current industry practices related to the conduct of clinical trials
- Excellent communication with site staff and internal BD teams
- English fluent (oral and written) and German or French
- Strong organizational skills and attention to detail
- Ability to manage multiple tasks and prioritize according to project needs
- Willingness to travel (30-60%, depending on project phase)
- Experience with CTMS/TMF software (e.g. Veeva) is an advantage

**Our Offer**
- Working in a global organization with highly motivated teams
- An innovative company with an environment where your input counts
- Office-/home-based position

**Primary Work Location**: DEU Karlsruhe