Job

Attention to Detail

Applies mental focus to their duties to ensure that work is accurate and error free and consistently pays attention to detail to ensure consistency of work and results to improve decision-making and achieve results or accomplish tasks/objectives.

Communication

Employs effective written, verbal and visual communication principles to ensure clear, timely and accurate information transfer to appropriate individuals to support decision making and appropriate action.

Critical Thinking

Applies accumulated knowledge of clinical research, personal experience and lessons learned from previous studies to prevent future problems. Analyzes the protocol and the stakeholders’ needs, clarifies requirements and develops solutions for complex data management issues that arise during the planning and execution of clinical trials. Also captures lessons learned from previous experience and adapts them to new contexts in order to facilitate effective problem-solving and risk management.

Data Management – Operations/Execution

Contributes to the overall success of a clinical trial by ensuring data collection, storage, cleaning, transfer and reporting processes are followed as defined in plans and study protocol. Also takes a lead role in the management of quality control and governance processes concerning all data management-related aspects of the study throughout the duration of the trial.

Data Management – Planning

Plans the data management process(es) and procedures that will be used to support the protocol and requirements of a clinical trial to ensure data quality and integrity will be maintained.

Data Review

Uses data surveillance tools and strategies to provide aggregate level reviews designed to identify patterns or anomalies in data to ensure high quality results.

Industry Compliance

Monitors to ensure results and assessments are properly documented, maintained and in keeping with regulatory reporting requirements, industry standard guidelines and any other timelines or requirements to maintain compliance.

Problem Solving

Demonstrates commitment to responsible performance throughout the duration of the study and to personal responsibility and transparency by holding to a high ethical standard for proper and consistent performance.

Project Management

Applies sound principles of project management to oversee the efficient execution of project plans and to ensure on-time, on-budget deliverables that meet the quality expectations of the client and the contract.

Stakeholder Relationship Management

Ensures customer’s needs and objectives are supported by consulting and providing clinical data management services.

Team Coordination

Acts as a resource for decision-making by providing support and contributing expertise, evaluation and advice in areas such as performance improvement, customer service delivery and consulting, operational and business process improvement reviews and related analytical process, data utilization, and reporting requirements. Also facilitates consensus with stakeholders as needed and identifies viable objectives, directions, and options.

Training

Applies comprehensive knowledge of clinical data systems to train personnel on electronic data capture (EDC) system, eCRF completion and quality control processes to ensure proficiency and minimize errors in data collection and storage.