Manager, Trial Disclosure, Medical Writing Operations
Crinetics Pharmaceuticals
2 months ago
Remote friendly (United States)
United States
$130,000 - $154,000 USD yearly
Operations
Position Summary
- Manage clinical trial transparency and disclosure activities, including initial trial postings, results postings, document redaction, and plain language summary development.
- Ensure accurate, compliant public release of clinical trial information in collaboration with cross-functional teams.
- Ensure redacted documentation complies with company confidential information (CCI) and the General Data Protection Regulation (GDPR).
Essential Job Functions and Responsibilities
- Ensure compliance with clinical trial transparency laws using FDAA 801 and Final Rule, and CTR 536/2014.
- Collaborate with cross-functional teams to develop content for trial and results postings and post approved materials per regulations.
- Develop and implement internal procedures, processes, templates, and tools for clinical trial disclosure.
- Develop and maintain CCI documents (process owner).
- Prepare redacted documents for postings, identifying CCI and personal protected information (PPI) under GDPR and other privacy laws.
- Apply logic, attention to detail, critical thinking, good judgment, and follow-up to deliverables.
- Maintain a customer-service mindset when working with cross-functional stakeholders.
Required Qualifications
- Bachelor’s degree required; advanced degree in life sciences/public health/regulatory science or related discipline preferred (MS, MPH, PharmD, PhD).
- 7+ years’ experience in Trial Disclosure (or closely related combined experience in clinical operations/regulatory affairs).
- Experience managing CT.gov for trial disclosure and results reporting timelines.
- Experience posting trial results to CTIS per regulatory timelines.
- Ability to translate clinical protocols into accurate disclosure postings and interpret clinical study reports for results postings (e.g., CT.gov, CTIS).
- Experience managing processes for development/review/approval of redacted documents (red box/black box) covering CCI and personally identifiable information.
- Cross-functional collaboration across scientific and operational disciplines.
- Strong project management skills; ability to manage multiple overlapping regulatory timelines.
- Experience with controlled electronic document management systems.
- Ability to incorporate/automate technologies to reduce manual processes.
- Excellent English verbal and written communication.
- Preferred: experience as process owner for CCI documentation.
Travel
- Up to 5%.
Benefits (if explicitly stated)
- Discretionary annual target bonus, stock options, ESPP, 401k match.
- Medical, dental, vision, and basic life insurance.
- 20 days PTO, 10 paid holidays, and a winter company shutdown.
- Salary range: $130,000–$154,000.
- Manage clinical trial transparency and disclosure activities, including initial trial postings, results postings, document redaction, and plain language summary development.
- Ensure accurate, compliant public release of clinical trial information in collaboration with cross-functional teams.
- Ensure redacted documentation complies with company confidential information (CCI) and the General Data Protection Regulation (GDPR).
Essential Job Functions and Responsibilities
- Ensure compliance with clinical trial transparency laws using FDAA 801 and Final Rule, and CTR 536/2014.
- Collaborate with cross-functional teams to develop content for trial and results postings and post approved materials per regulations.
- Develop and implement internal procedures, processes, templates, and tools for clinical trial disclosure.
- Develop and maintain CCI documents (process owner).
- Prepare redacted documents for postings, identifying CCI and personal protected information (PPI) under GDPR and other privacy laws.
- Apply logic, attention to detail, critical thinking, good judgment, and follow-up to deliverables.
- Maintain a customer-service mindset when working with cross-functional stakeholders.
Required Qualifications
- Bachelor’s degree required; advanced degree in life sciences/public health/regulatory science or related discipline preferred (MS, MPH, PharmD, PhD).
- 7+ years’ experience in Trial Disclosure (or closely related combined experience in clinical operations/regulatory affairs).
- Experience managing CT.gov for trial disclosure and results reporting timelines.
- Experience posting trial results to CTIS per regulatory timelines.
- Ability to translate clinical protocols into accurate disclosure postings and interpret clinical study reports for results postings (e.g., CT.gov, CTIS).
- Experience managing processes for development/review/approval of redacted documents (red box/black box) covering CCI and personally identifiable information.
- Cross-functional collaboration across scientific and operational disciplines.
- Strong project management skills; ability to manage multiple overlapping regulatory timelines.
- Experience with controlled electronic document management systems.
- Ability to incorporate/automate technologies to reduce manual processes.
- Excellent English verbal and written communication.
- Preferred: experience as process owner for CCI documentation.
Travel
- Up to 5%.
Benefits (if explicitly stated)
- Discretionary annual target bonus, stock options, ESPP, 401k match.
- Medical, dental, vision, and basic life insurance.
- 20 days PTO, 10 paid holidays, and a winter company shutdown.
- Salary range: $130,000–$154,000.