Executive – Regulatory Affairs
Sun Pharma
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Job Description
Company: Red Nucleus
Category: Associate / Senior Associate, Clinical Data Management
Location: Remote, India
Introduction
The RN Associate / Senior Associate, Clinical Data Management is responsible for delivering and overseeing clinical and patient reported data within electronic data capture (EDC) platforms, including iTakeControl. Activities include monitoring databases and video evidence, maintaining data quality, and database integrity for research studies from conception to closeout. The role will work closely with the Clinical Operations, Product Management and Technical Delivery teams and is responsible for detailed specification development, documentation, and supporting clinical operations, project management and delivery activities for Clinical and iTakeControl (iTC) product client projects.
Role & Responsibilities
- Be the point of contact, maintain daily interactions and lead calls with internal and external stakeholders with supervision.
- Manage data management timelines, milestones and adhere to deadlines with supervision.
- Provide data management support including project, sponsor, site and vendor management with supervision.
- Understand real world protocols, data collection processes, and GxP processes.
- Maintain data integrity.
- Understand study requirements, EDC and or EHR systems, user needs, and logical business requirements with guidance.
- Understand ePRO systems for patient-centric research, data collection, and patient engagement with guidance.
- Perform clinical and/or ePRO data review (including video data), query generation and data reconciliation with supervision.
- Manage data transfer, export, extraction, migration process as needed per client requirements with supervision.
- Develop documentation including Data Management Plan and EDC supporting documentation such as CRF Specifications, eCRFs, etc. with supervision.
- Develop and manage required support documentation including training content, caregiver/site manuals, etc.
- Participate in Site Initiation Visits (SIV) and site/central rater training as needed.
- Support UAT and product launch requirements.
- Adhere to quality and compliance (e.g., SOPs, etc.) and regulatory requirements.
- Prioritize and manage project schedules and effectively report and communicate progress.
- Work closely with customers and other-cross functional team members, from biotech clients to technical developers.
- Explore options for remote data monitoring of research site source data.
- Perform literature searches to assist in addressing requests by the team or clients.
- Well organized, obsessed with details, and capable of juggling multiple projects.
- Be confident and comfortable asking questions in a time of need.
- Support external audits and assist in audit response efforts.
- Willing and eager to learn new technology and work with iOS and Android applications.
- Assist with quality control testing to requirements.
- Support team members.
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Educational Qualification
- Undergraduate degree from an accredited University.
- 0-10 years professional experience.
- Rare diseases, gene therapy, long term follows up.
- Previous experience working with central or specialty labs/vendors.
- Experience with data management per clinical study protocols, amendments, observational research and/or registries.
- Experience with data migrations, reporting and transfers.
- Experience with health data collection, compliance standards, such as FDA 21 Part 11, Annex 11, and other privacy policies and practices.
- Professional experience within biopharma or pharmaceutical industry, contract research organization (CRO), clinical study site, or consulting.
- Knowledge of GCP, ICH, HIPAA, GDPR, and FDA requirements for human subject research and their application to clinical operations.
- Knowledge of registries and/or clinical drug development pathways, including Phase 1-3 studies.
Location
Remote, India
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