What are the responsibilities and job description for the CLINICAL TRIAL TRANSPARENCY SPECIALIST position at Daiichi Sankyo?
Employment as a Contingent Worker aligns well with individuals seeking career flexibility and non-traditional work arrangements, while also being motivated to produce exceptional results in prominent roles. Magnit Direct Source is a service provided by Magnit Global that connects top-tier talent directly to an industry-leading company. Daiichi Sankyo, Inc. and Magnit Global, in collaboration, offer flexible contingent assignments across diverse projects creating opportunities for engaging work. As a Contingent Worker, you will not be employed Daiichi Sankyo, Inc. You will be employed by our Managed Service Provider, Magnit Global, which oversees the majority of our temporary contract recruitment.
Job Schedule: Candidate can work 100% remote for duration of contract. Highly prefer candidate to be EST/CST based; HM is open to candidates in other time zones as long as they're able to work/support EST/CST hours.
Job Title: CLINICAL TRIAL TRANSPARENCY SPECIALIST
Job Schedule: Candidate can work 100% remote for duration of contract. Highly prefer candidate to be EST/CST based; HM is open to candidates in other time zones as long as they're able to work/support EST/CST hours.
The Clinical Trial Transparency Specialist is responsible for the planning, execution, and oversight of global clinical trial transparency and disclosure activities to ensure compliance with applicable regulatory, legal, and company requirements. The role serves as a subject matter expert for United States and European Union clinical trial transparency regulations, including ClinicalTrials.gov, the EU Clinical Trials Regulation (CTR), CTIS, and EMA Policy 0070 requirements. The specialist manages end-to-end transparency workflows, provides oversight of external vendors and CRO partners, and coordinates cross-functional activities to ensure timely, accurate, and compliant study registrations, results disclosures, document redactions, and public disclosure activities while protecting participant privacy and commercially confidential information.
Responsibilities
Regulatory Expertise and Compliance
- Serve as the subject matter expert for U.S. and EU clinical trial transparency and disclosure requirements, including ClinicalTrials.gov, FDAAA 801, EU CTR/CTIS, and EMA Policy 0070 requirements.
- Monitor evolving transparency regulations and industry best practices and assess operational impact on disclosure activities.
- Provide regulatory guidance to study teams and functional stakeholders regarding registration, results disclosure, plain language summaries, redaction, and publication requirements.
- Ensure compliance with applicable disclosure timelines and regulatory obligations across assigned studies and programs.
Vendor Oversight and Management
- Serve as the primary operational liaison for transparency and disclosure vendors, consultants, and CRO partners.
- Oversee vendor performance to ensure quality, compliance, productivity, and adherence to contractual expectations and disclosure timelines.
- Review vendor deliverables, identify quality issues, and implement corrective actions as needed.
- Support vendor onboarding, training, process alignment, and continuous improvement initiatives.
Internal Workflow Management and Operational Oversight
- Own and manage the internal transparency and disclosure workflow from study startup through final disclosure activities.
- Develop and maintain disclosure plans, milestone tracking, and activity dashboards to ensure timely completion of all required deliverables.
- Facilitate cross-functional reviews and approvals and proactively identify risks that may impact compliance or disclosure timelines.
- Establish and maintain operational processes, job aids, tracking tools, and metrics to support efficient execution of transparency activities.
- Drive continuous process improvements to enhance quality, consistency, compliance, and operational effectiveness.
- 5 or more years Experience as a transparency specialist with project management experience at pharmaceutical company or equivalent
- Clinical Trial Transparency Subject Matter Expertise
- Regulatory Compliance Management
- Vendor and CRO Oversight
- Workflow and Process Management
- Cross-Functional Leadership
- Stakeholder Engagement
- Quality and Compliance Focus
- Risk Identification and Mitigation
- Continuous Improvement Mindset
- Strong Communication and Organizational Skills
- Proficiency in Microsoft Office, Adobe Acrobat, and TMF/EDMS systems
Required: Completed Bachelor’s degree in a relevant scientific field
Hourly Pay Rate Range (dependent on location, experience, expectation)
The pay range that Magnit reasonably expects to pay for this position is: $ 60-70/hr
Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met)
#REMOTE
QUALIFICATION/LICENSURE
Work Authorization : US Citizen
Preferred years of experience : 1 years
Travel required : No travel required
Shift timings :
Benefits:
Health Insurance, 401K Plan, Dental InsuranceSalary : $60 - $70