Sr. Clinical Trials Transparency & Disclosure Specialist
About The Position
The Sr. Clinical Trials Transparency & Disclosure Specialist is responsible for supporting and executing Celldex Therapeutics' global clinical trial transparency and disclosure activities. This role ensures compliance with applicable regulatory requirements and company policies related to clinical trial registration, results disclosure, and public dissemination of clinical trial information. Working collaboratively with Clinical Operations, Regulatory Affairs, Biostatistics, Medical Writing, Legal, and other cross-functional stakeholders, the Clinical Trials Transparency & Disclosure Specialist serves as a subject matter expert for transparency and disclosure requirements across the development portfolio. The role is accountable for the timely and accurate registration of clinical studies, submission of clinical trial results, maintenance of disclosure records, oversight of transparency-related processes, and continuous improvement of compliance practices. This position supports Celldex's commitment to regulatory compliance, scientific integrity, and public trust.
Requirements
- Bachelor's degree in Life Sciences, Public Health, Regulatory Affairs, Clinical Research, or a related discipline; or an equivalent combination of education, training, and relevant professional experience.
- 3–5 years of experience in clinical research, clinical operations, regulatory affairs, clinical disclosure, or a related pharmaceutical/biotechnology function.
- Experience working in a GCP-regulated environment.
- Understanding of clinical trial processes and clinical development.
- Knowledge of clinical trial transparency and disclosure requirements.
- Excellent attention to detail and commitment to accuracy.
- Strong written and verbal communication skills.
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- Proficiency with Microsoft Office applications and clinical systems.
- Accountability and ownership of assigned deliverables.
- Proactive and solutions-oriented approach.
- Commitment to compliance, quality, and continuous improvement.
- Ability to build collaborative relationships across departments and with external partners.
- High level of professionalism, integrity, and attention to detail.
Nice To Haves
- Experience working with ClinicalTrials.gov, CTIS, EudraCT, or similar clinical trial registries preferred.
- Familiarity with global clinical trial disclosure requirements, including FDAAA, EU Clinical Trial Regulation (CTR), and other applicable transparency requirements.
Responsibilities
- Manage the planning, execution, and oversight of global clinical trial registration and results disclosure activities in accordance with applicable regulations and company policies.
- Ensure timely and accurate registration, maintenance, and updating of clinical trial records in public registries, including ClinicalTrials.gov, CTIS, and other applicable regional registries.
- Coordinate the preparation, review, and submission of clinical trial results disclosures in accordance with applicable regulations and company timelines.
- Monitor evolving global disclosure regulations and industry guidance, assessing impact on company processes and compliance requirements.
- Maintain complete and inspection-ready disclosure documentation, records, and compliance metrics.
- Partner with cross-functional teams to gather required information and ensure accurate and consistent public reporting of clinical trial information.
- Provide strategic guidance and operational support for transparency and disclosure activities throughout the clinical development lifecycle.
- Support audits, inspections, and internal compliance reviews related to clinical trial transparency obligations.
- Develop, implement, and continuously improve standard operating procedures (SOPs), work instructions, and training materials related to transparency and disclosure.
- Track disclosure deadlines, identify compliance risks, and proactively implement mitigation strategies.
- Generate reports and metrics to communicate program status, compliance performance, and key disclosure milestones to management.
- Serve as a subject matter expert and resource for transparency and disclosure requirements across the organization.
Benefits
- annual discretionary bonus
- long term incentive
- 401(K) plan with employer contribution
- health care and other insurance benefits (for employee and family)
- paid holidays
- vacation
- sick days
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
