AI Engineering Lead responsible for infrastructure and development of AI agents in product analytics. Managing tools, standards, and governance for a team supporting 60+ products.
About the role
- Data Manager leading data management activities for clinical trials at ClinChoice. Ensuring deliverables meet timelines and quality while collaborating with cross-functional teams.
Responsibilities
- Lead Data management activities and ensure study deliverables meet timelines and quality standards.
- Review of Clinical research documents (e.g. protocols, Case Report Forms).
- Create and review electronic Case Report Form (eCRF) specifications.
- Develop critical DM documents such as the Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, Data Entry Guidelines and Data Review Plan.
- Develop edit rules/checks, query logic and query messages.
- Develop User Acceptance Testing Plan and perform testing on data entry screens and edit checks.
- Create and provide training to the clinical team and sites.
- Perform ongoing data review/reconciliation activities and provide metrics and patient trackers to monitor data clean up.
- Perform database lock/unlock and freeze/unfreeze activities as appropriate for statistical review, interim analysis, and final database lock.
- Coordinate the archiving of study databases and related documents
- Create Data Transfer Specifications and perform external vendor reconciliation.
- Perform SAE reconciliation.
- Work to maintain/improve client satisfaction by ensuring high quality service, communication and management of clinical data.
Requirements
- Bachelor’s degree in clinical/pharmacy biological/mathematical sciences or related field or nursing degree.
- Atleast 3 years data management and/or related work experience in a pharmaceutical industry.
- Working knowledge of Clinical research and clinical trial process and related regulatory requirement and terminology.
- Strong knowledge and experience in several Electronic Data capture systems such as Medidata Rave, Oracle InForm, OpenClinica and Medrio.
- Perform duties in compliance with SOPs, GCP and ICH guidelines.
- Ability to prioritize and to adapt quickly in fast-paced and changing industry conditions.
- Ability to lead a study or data management team independently.
- Proactively drive quality and efficiently to meet timelines and milestones to deliver high quality data management deliverables.
- Excellent verbal and written communication skills.
- Proficient in the use of Microsoft office(Outlook, word, excel, powerpoint, etc)
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