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Senior Clinical Data Manager I

2 months ago

Chennai, Tamil Nadu, India Allucent Full time
About the Role

We are seeking a highly skilled and experienced Senior Clinical Data Manager I to join our team at Allucent. As a key member of our Data Management department, you will be responsible for leading data management activities and ensuring the completeness, accuracy, and consistency of clinical data meets quality standards and regulatory requirements.

Key Responsibilities
  • Lead and serve as primary contact for Data Management with all relevant parties both internally and externally.
  • Plan and project resources required, including management of tasks, timelines, risk, and quality.
  • Monitor tasks against budget, forecasts, and manage changes of scope, budget, revenue recognition.
  • Develop, review, and maintain project-specific Data Management documents, including data management plans, eCRF specifications, data validation plans, and external data transfer agreements.
  • Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements.
  • Participate in the review of study documents, lead and coordinate the review of (electronic) case report forms (eCRFs).
  • Coordinate, oversee, and ensure the database User Acceptance Testing (UAT) related tasks are successfully completed.
  • Create training materials for EDC users and provide project-specific training as required.
  • Lead and oversee the review and validation of clinical data to ensure consistency, accuracy, integrity, and completeness.
  • Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock).
  • Perform and/or coordinate various data transfers and reconciliation activities, including (but not limited to) SAE, PK, and (other) external laboratory data.
  • Provide project metric reports, status updates, study progress, feedback, and advice to project team on site performance issues, data trends, and protocol non-compliance.
  • Organize and lead Quality Review activities during study.
  • Assist in project-related contracts negotiation and contracting process with vendors (EDC, IRT, eCOA).
  • Manage the database maintenance, lock, and close-out processes and procedure.
  • Participate in conference calls and/or meetings with vendors and sponsors.
  • Recognize and solve potential problems and evaluate effectiveness.
  • Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date.
  • Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned.
  • Help to align data management and clinical programming best practices, standards, and conventions within the company.
  • Provide leadership, expertise, and support to other department members.
  • Propose and support initiatives for improving efficiency.
  • Actively support staff learning & development within the company.
  • Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions.
  • Represent the company at professional meetings, webinars, or seminars.
  • Train and mentor data management staff, support in development of new training material, and provide training to relevant staff.
  • Participate in the interview process for new recruits.
  • Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes.
  • Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System.
  • Assure good communication and relationships with (future) clients.
  • Contribute to and take part in client evaluations and visits.
  • Support in preparation of new proposals and budgets for Data Management services.