Position Overview
Under the direction of the applicable management, the Senior Clinical Data Manager (SCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to: data management tool and system development, validation and maintenance, data integrity review and reconciliation, query management, and database lock preparation/execution, in compliance with Standard Operating Procedures (SOPs) and ICH-GCP guidelines. In Early Stage Development (ESD), the SCDM may have sole responsibility for these activities; in Late Stage Development (LSD), the SCDM's execution of these activities may be overseen by a Lead Clinical Data Manager (LCDM) or other manager. In addition, the SCDM may be appointed to support quality & maintenance of any new/updated eDT/eCRF and its associated Data Validation (DV) components across all Standards Libraries by ensuring the appropriate use of Core/Generic, TA and Industry Standards concepts.
We have seven opportunities for a Senior Clinical Data Manager.
Basic requirement:
•Minimum 3 years of experience in Data Management, in a Senior Clinical Data Manager or Clinical Data Manager role at the time of application.
Responsibilities
•All responsibilities of a Clinical Data Manager (CDM).
•May be responsible for in-life and database lock tasks and activities.
•Assume data management responsibilities for larger, more complex or higher priority protocols.
•Triage, research, discuss and resolve the reports outputs provided by Clinical & Statistical stakeholders at a protocol level during in-life and database lock stages. Execute special reports in different systems and coordinate resolution of the outputs.
•Responsible for the preparation, creation, validation and review of data management tool specifications, including but not limited to: eCRFs, Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans (DRPs) and In-life Reports, Encoding and Data Management Plans (DMPs).
•Coordinate User Acceptance Testing (UAT) of the Clinical Database.
•Responsible for communication with Clinical team regarding site level issues on a protocol.
•Coordinate communications, global status tracking and issue resolution at study level.
•Interact and communicate with customers and stakeholders both internal and external to GDMS as well as internally when needed.
•Responsible for study level status assessment, reporting and communication with LCDM, or with the assigned trial manager.
•Monitor protocol level cycle time performance (metrics) and follow up on specific countries/sites metrics issues and deliver status and resolution updates to appropriate parties.
•May coordinate general ad-hoc Sponsor Data Entry (SDE) process for the protocol, discuss timelines and provide data entry status to Clinical stakeholders.
•Coordinate and mentor CDMs and other SCDMs who work on the same protocol to maintain compliance with SOPs, data management plans and data review plans.
•May be assigned special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/or other special activities, such as providing inputs to create or update SOPs, supporting documents and training materials as needed.
•May contribute to special activities such as supporting Process Owner (PO) Models in the local data management center and/or in the Global PO networks.
•Participate in cross functional technical or process improvement projects.
Required Skills
Clinical Data Management, Clinical Data Review, Clinical Development, Clinical Information Systems, Clinical Reporting, Clinical Trials Monitoring, Data Operations, Data Processing, Data Quality Assurance, Data Validation, Drug Development, Medical Billing and Coding, Pharmacovigilance, Regulatory Compliance
Flexible Work Arrangements: Hybrid
