Sr. Clinical Trials Transparency & Disclosure Specialist

Role: Senior Clinical Trials Transparency & Disclosure Specialist supporting Celldex's global clinical trial transparency activities. Responsibilities: manage registration and results disclosure of clinical studies across public registries (e.g., ClinicalTrials.gov, CTIS), ensure compliance with evolving regulations (FDAAA, EU CTR), prepare documentation, monitor deadlines, and develop SOPs. Serve as SME on transparency requirements, provide strategic guidance, and support audits and training. Qualifications: Bachelor's in Life Sciences, Public Health, or related field; 3-5 years in clinical research, regulatory affairs, or clinical disclosure; experience with clinical trial registries and knowledge of GxP and global transparency regulations. HighValue: focus on clinical trial disclosure, regulatory compliance, GCP environment, experience with global registries, and understanding of clinical development processes.