Job Description

Job Title : Clinical Trial Disclosure Manager-EG 100 Division Research & Development Functional Area Description: Global Development Operations / Trial Delivery Support / Clinical Trial Transparency & Disclosure Location : Hyderabad (Hybrid) Key Skills/Key Words: Regulatory Medical Writing/Regulatory Medical Writer, CSRs/ CT Protocols/Document Redaction/Clinical Trial Disclosure Manager/Project Management/ Position Summary / Objective: The Clinical Trial Disclosure Manager will provide the operational support of Redaction of clinical trial documents in accordance with evolving global regulations. Key business partners are Clinical Development/Early Development Leads, Global Development Operations, Global Biostatisticians, Legal, Publications, Information Technology, Alliance Partners, Medical Writing, and Submission Managers. Position Responsibilities: Manage and coordinate projects related to the redaction of clinical documents in accordance with EU Clinical Trial Regulation (EUCTR), EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), and other global regulations Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements Perform quality control of redacted documents. Provide vendor oversight to support redaction of documents. Work with IT, as needed, to implement technology solutions related to clinical trial disclosure. Manage and track redaction book-of-work; compile and report on volume and performance metrics. Provide operational support to CT Results Managers, as required Assists in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements Communicates with internal and external stakeholders to improve on processes and manage unmet need. Develop training and drive change management for novel processes related to the EU Clinical Trial Regulation and other regulations. Train new staff and develop job aids, work instructions, and user guides, as needed. Degree Requirements: BA/BS or MA/MS in scientific or medical field Experience Requirements: 5+ years relevant work experience in scientific or medical field with BA/BS 2-3 years of work experience in redaction of clinical documents Key Competency Requirements: Project and stakeholder management experience. Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies (PhRMA/EFPIA principles for responsible data sharing etc Familiarity and comfortability working with and discussing scientific data. Demonstrated ability to work independently and seek out support when needed. Exceptional written and oral communication skills. Strong organizational skills with the ability to multitask and prioritize.

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