Head of Clinical Trial Monitoring (m/f/d)

Ihre Aufgaben

• Accountable for the successful conduct of site monitoring activities across assigned studies, from site identification and selection to site close-out

• Ensures clinical trials are conducted in compliance with Good Clinical Practice, local regulations, study protocols, and SOPs

• Authors or reviews Clinical Monitoring Plan(s) to ensure agreement with protocol, Standard Operating Procedures, and Good Clinical Practice

• Collaboratively establishes action plans to address findings works in partnership with Study Management Team members to ensure that site monitoring activities support the overall study plan

• Maintains strong relationships with CROs and investigative sites

• Responsible for direct management of internal monitoring personnel (e.g., Lead Clinical Research Associates), including hiring, onboarding, and performance management

• Reviews proposed CRO monitoring staff against the established qualifications

• Represents the site monitoring function at SME meetings.

• Performs other tasks as needed for successful study execution and as requested by management,

• An exciting field of activity in a challenging clinical environment

• An independent area of responsibility

• Active participation in an international clinical team

• Intensive training with mentoring program

Ihr Profil

• Bachelor's degree in scientific discipline required; master's degree or higher preferred

• At least 8 years' experience monitoring clinical sites and/or managing Clinical Research Associates in clinical operations in biotech / pharma companies and/or CRO experience managing or monitoring Phase I-III clinical trials or medical device trials

• Demonstrated expertise in Good Clinical Practice; experience with site or sponsor regulatory inspection(s) highly desirable

• Experience with clinical systems, including eCRFs and eTMFs

• Willingness to be an individual contributor or hands-on leader, according to project demands

• Preferred Experience:

• Experience in cardiac and endovascular procedures strongly preferred

• Excellent problem-solving skills and an appropriate sense of urgency

• Experience with Risk Based Monitoring is a plus

Kontakt

Ina Müller, jobs.europe@artivion.com, T: 07471 922 441 JOTEC GmbH, a wholly owned subsidiary of Artivion, Inc., Lotzenäcker 23, 72379 Hechingen www.artivion.com