Senior Clinical Data Manager: Perform data management tasks from study start up through database lock, including database set-up and data validation as per the requirements in the clinical protocols and ensure timely delivery of high-quality consistent data. Lead portions of a project with no supervision or a full project with minimal supervision.
ResponsibilitiesParticipate in writing departmental procedures and guidelines.
Adherence to SOPs and maintaining audit-ready documentation.
Perform User Acceptance Testing: test database design, validate edit checks or system settings according to specifications, document and address the testing outcome.
Ensure user acceptance testing (UAT) is completed prior to implementation and deployment to sites
Coordinate data management activities, ensuring high quality, respecting project timelines and adherence to the budget for a full project or dedicated part of a project.
Create and run data management reports.
Coordinate and create data management documentation including Data Management Plan, Data Validations Specifications, eCRF Completion Guidelines, Data Collection System Configuration, Data Transfer Agreement.
Attend relevant project meetings and work closely with other internal and external leads.
Liaise with client/partners for clarification on any clinical and / or technical decisions and propose most efficient, successful solutions.
Identify risks to project deliverables and timelines and notify the appropriate personnel.
Manage EDC users’ access and assist with resolving issues.
Train EDC users.
Track and enter local lab ranges.
If acting as Lead Clinical Data Manager, create DM timelines for database set-up.
Lead and participate in the design of Clinical Electronic Data Capture (EDC) components including mock CRF, casebook, edit checks.
Lead and participate in data cleaning activities including SAE and external data reconciliation.
Participate in writing departmental procedures and guidelines.
If acting as Lead Clinical Data Manager, coordinate all conduct Data Management tasks.
Provide input to protocol and assess database impacts based on protocol changes during study lifecycle; prepare and execute change request forms.
Lead and participate in Database Lock activities, including timelines creation, QC coordination and Data Management Report creation.
Assist with evaluating data management needs and propose appropriate, innovative, and efficient data management solutions.
Train and mentor less experienced staff.
Ensure all relevant project documentation is initiated, up to date and follows SOP and other relevant regulations, to support the project oversight, execution and delivery of services
Provide Senior Management regular updates regarding the status and progress of projects, in accordance with standard practice. Analyze data reported to identify themes that can ne remediated
Oversee project risk development and mitigation plans.
Actively manage clients' communication & interaction, with an aim to have high client satisfaction. Ensure client is aware of current status of timelines, scope and budget.
QualificationsBachelor’s degree in Life Sciences, Computer Science, or health information management related discipline
A minimum of five years of progressive experience in Clinical Data Management and/or Clinical Research
Strong awareness about different electronic data capture tools and metadata
Strong experience working with patient study data such as: Laboratory and PK/PD Data, Device Data (ECG, Flowmetry, Vital Signs, Images, and other), Electronic Patient Diaries
