- Company Name
- Real Staffing Group
- Job Title
- Director, Clinical Trial Data Transparency & Disclosure
- Job Description
-
**Job Title:** Director, Clinical Trial Data Transparency & Disclosure
**Role Summary:**
Lead the global strategy and execution of clinical trial data transparency, ensuring compliance with U.S. and international regulations (FDA/ClinicalTrials.gov, EU CTR, EMA Policy 0070, Health Canada, Japan PMDA, Australia TGA, UK MHRA, WHO). Develop policies, governance frameworks, and cross‑functional processes to disclose trial information, results, and patient‑level data while maintaining privacy standards. Represent the organization in external forums and drive proactive updates to meet evolving regulatory requirements.
**Expectations:**
- 8‑10 years in regulatory affairs, clinical research, or medical writing with at least 5 years focused on clinical trial disclosure.
- Proven leadership of global teams and major transparency initiatives.
- Experience representing an organization in industry working groups (PhRMA, BIO, TransCelerate, CTTI).
- Deep knowledge of global disclosure regulations and data privacy laws (GDPR, HIPAA).
- Ability to develop and maintain effective governance frameworks, SOPs, and quality standards.
**Key Responsibilities:**
- Define and execute the global clinical data transparency strategy aligned with corporate objectives.
- Serve as subject‑matter expert for all major registries (ClinicalTrials.gov, EU CTR, EudraCT, EMA Policy 0070, Health Canada PRCI, PMDA, WHO).
- Anticipate regulatory changes and drive timely policy and process updates.
- Represent the organization in external industry forums, working groups, and regulatory discussions.
- Establish and maintain disclosure governance, SOPs, quality standards, and audit readiness.
- Oversee redaction, anonymization, and privacy‑compliant data‑sharing strategies.
- Provide guidance on plain‑language summaries and patient‑facing transparency deliverables.
- Direct registration, result posting, and updates across all global registries.
- Manage vendors, technology platforms, and disclosure service providers.
- Partner with Clinical Development, Operations, Medical Writing, Biostatistics, Data Management, Pharmacovigilance, Legal, Communications, Investor Relations, and Regulatory Affairs to ensure consistent, accurate disclosures.
- Deliver training and best‑practice guidance to internal teams.
- Foster a culture of accountability, quality, and innovation across R&D.
**Required Skills:**
- Leadership, strategic thinking, and change management.
- Strong written and verbal communication, stakeholder engagement, and collaboration.
- Expertise in global regulatory frameworks for clinical trial disclosure.
- Knowledge of data privacy law compliance (GDPR, HIPAA).
- Experience with data anonymization, redaction technologies, and patient‑level data‑sharing platforms.
- Ability to build and sustain governance frameworks and audit‑ready processes.
**Required Education & Certifications:**
- Bachelor’s degree in Life Sciences, Pharmacy, Biomedicine, or related field; advanced degree preferred.
- Regulatory Affairs or related certification (e.g., RAB, CRA‑P) is highly desirable.