Associate Director, Clinical Affairs

The Position:

The Associate Director, Clinical Affairs (Europe) oversees the full lifecycle of clinical studies, ensuring compliance with European regulations and standards. This includes protocol development, implementation, closeout, and reporting. The role manages study documentation, trains staff, monitors progress, ensures protocol and regulatory compliance, and oversees budgets, timelines, and vendor relationships. The position also maintains study metrics, contributes to scientific publications and regulatory submissions, and serves as the clinical affairs representative on cross-functional teams.

About 25% travel will be required for this role, most travel will take place in Europe. This individual may need to be available for occasional meetings that take place virtually in the United States. We are in search of a candidate based in Norway; however, we are open to considering candidates based in Central and Western Europe.

Key Responsibilities

• Regulatory Compliance:

• Ensure all clinical studies are conducted in accordance with EU Clinical Trials Regulation (EU CTR No. 536/2014), ICH-GCP, ISO 20916, Veracyte SOPs, and relevant national requirements.
• Oversee submissions to Ethics Committees (ECs) and Competent Authorities via the Clinical Trials Information System (CTIS).
• Maintain compliance with GDPR for data protection and patient privacy.
• Ensure adherence to In Vitro Diagnostic Regulation (IVDR, EU 2017/746) for relevant studies.

• Study Management:

• Lead planning, execution, and oversight of clinical studies, ensuring delivery on time, within budget, and in compliance with European and global standards.
• Develop essential study documents (protocols, informed consent forms, case report forms, training manuals, monitoring plans, SOPs).
• Coordinate selection and oversight of CROs, vendors, clinical sites, and investigators across Europe.
• Facilitate IRB/EC submissions and ensure regulatory compliance throughout the study lifecycle.
• Manage study conduct, including site training, communications, initiation, monitoring, and close-out visits.
• Maintain Trial Master Files (TMFs) and ensure documentation integrity.

• Cross-Functional Collaboration:

• Collaborate with Medical Affairs, Product Development, Managed Care, Commercial, Regulatory Affairs, and Market Access teams to implement clinical development strategies aligned with product goals.
• Build and maintain scientific relationships with key investigators, institutions, and consortia in Europe.
• Communicate evolving priorities and study updates across clinical and cross-functional teams.
• Flexibility of work hours to accommodate collaboration with US-based colleagues

• Data Quality & Reporting:

• Review and support execution of data management and statistical analysis plans.
• Ensure data quality through monitoring plans, data reviews, and process control checks.
• Oversee adverse event reporting in accordance with European regulatory and SOP requirements.
• Contribute to process improvements and stay informed on trends in clinical study design and execution.

• Leadership & Mentoring:

• Mentor and oversee clinical research staff as needed.
• Develop and manage detailed project plans and provide regular study status updates.

Who You Are:

• Education & Experience:

• A minimum of 8 years of experience in clinical research, preferably in diagnostics or medical devices, and direct experience in clinical study management.
• Bachelor’s degree in a Science or STEM field required; advanced degree preferred.

• Skills & Knowledge:

• Expertise in IVD assay and instrumentation product development, including design control processes.
• Proven ability to lead and contribute effectively within cross-functional teams.
• Experience managing diverse study types, including sponsored trials, research collaborations, and investigator-initiated studies.
• Strong research background in clinical study design and implementation, with working knowledge of biostatistics.
• Familiarity with regulatory frameworks including EMA, FDA, IVDR, and other international guidelines relevant to clinical studies and submissions.
• Ability to manage multiple studies and programs simultaneously with precision and efficiency.
• Highly self-motivated, detail-oriented, and skilled in prioritizing tasks to meet critical deadlines while balancing project risks and timelines.
• Demonstrated strengths in critical thinking, problem-solving, and negotiation.
• Excellent interpersonal, verbal, and written communication skills, including presentation delivery.
• Proficient in essential software tools for communication, task management, tracking, and document development.
• Hands-on experience with clinical trial management systems (CTMS), electronic data capture (EDC), and electronic trial master files (eTMF).
• Familiarity with clinical databases and sample biobanking software.

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