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Our client a leading pharmaceutical company is looking to engage with a Consultant responsible for executing global clinical trial disclosure activities, including registration, maintenance, and results posting across public registries such as ClinicalTrials.gov, EudraCT, and EU CTR under guidance from Global Clinical Trial Disclosure Managers. The position involves hands-on authoring of basic results, compliance with global transparency regulations, and cross-functional collaboration with study teams under guidance of Disclosure Managers. The individual ensures timely, accurate, and high-quality disclosure of trials and results in alignment with regulatory requirements and internal standards.
Key Responsibilities
Submit global clinical trial registration and updates on public registries.
Ensure compliance with global transparency regulations (FDAAA 801, Final Rule, EU CTR) and internal SOPs.
Monitor disclosure milestones (FSFV, PCD, LSLV) and manage risks to timelines, escalate risks and issues to manager.
Support maintaining audit-ready documentation and support internal/external inspections.
Collaborate with cross-functional teams (clinical, regulatory, legal) to align disclosure activities.
Author, review, and finalize clinical trial basic results for registries (ClinicalTrials.gov, EudraCT/CTIS).
Work closely with programmers and statisticians to collect required source documents, datasets, and tables that support the authoring of basic results.
Transform statistical outputs into registry-compliant tables and narratives.
Track milestones for results posting and ensure adherence to regulatory requirements.
Support process improvements and system enhancements for disclosure and results reporting.
Support clinical trial internal and external data sharing commitments including operational execution and compliance:
o Communicate with study teams for information sharing purposes for ParticipantData Return (PDR) and be point of contact for study teams.
o Use reports to identify studies due to return data, contacting study teams to engage in PDR (Compliance)
o Identify process improvement opportunities based on input from study teams
o Project Manage identified process improvement projects for PDR and data sharing
Duration- 6 months
Capacity- Full time
Location- Mumbai, Hybrid (1-2 day office)
-Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field.
- Experience: 5 years in the pharmaceutical industry with strong knowledge of clinical trial operations, disclosure regulations, or medical writing.
- Project management and organizational skills.
- Understanding of global disclosure regulations and guidelines.
- Excellent communication and stakeholder management abilities.
- Analytical and critical thinking skills with attention to detail.
- Ability to work cross-functionally, managing ambiguity and conflicting priorities.
- Strong interpersonal skills.
- Flexibility to work across therapeutic areas and development phases.
- Medical research background with breadth and depth of knowledge of clinical trial disclosure preferred
- Experience with Xogene Prime application is a plus.
- Ability to work effectively across cultures and time zones.
Leading pharmaceutical and biotechnology corporation
Pharmaceuticals, Healthcare Providers & Services (Hospitals, clinics, diagnostics)
5+ years
1
Pharmaceuticals
6 months
5+ years
Hybrid
Government
6 months
4+ years
On-Site
Professional Services - Data Analytics
6 months
2+ years
Remote
Professional Services - Data Analytics
6 months
1+ years
Remote
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