Senior Data Manager

📋 Description

• • As a Senior Data Manager at Alira Health, you will be instrumental in ensuring the successful execution of data management tasks for assigned clinical studies, consistently meeting project milestones and staying within budget.
• • You will collaborate closely with Sponsors, clinical teams, and statisticians to meticulously develop data collection specifications, ensuring all data sources are accurately defined and integrated.
• • Your role involves managing the in-stream data flow activities, guaranteeing the delivery of a high-quality database that adheres strictly to the project plan and regulatory standards.
• • You will lead and motivate the Data Management (DM) team, fostering a collaborative and efficient working environment.
• • You will serve as the primary point of contact for the Sponsor and the designated project lead from a data management perspective, ensuring clear communication and alignment.
• • You will be accountable for driving the achievement of all project milestones, from the initial study start-up phase through to the final delivery of the database.
• • A key responsibility is providing critical Data Management input during the protocol development phase, ensuring data collection strategies are robust and aligned with study objectives.
• • You will design the Case Record Form (CRF) and guide the entire process for CRF approval, ensuring accuracy and compliance.
• • You will define and develop comprehensive Data Management Plans (DMPs), Data Validation Plans (DVPs), and their associated annexes, such as Reconciliation Plans, with essential input from the study team.
• • A significant part of your role will involve the validation of the database and computerized checks, including the creation and execution of SAS listings or SAS checks to ensure data integrity.
• • For Electronic Data Capture (EDC) studies, you will define the User Acceptance Test (UAT) Plan and execute test activities within the test environment to guarantee the quality and functionality of the electronic CRF (eCRF).
• • You will provide timely responses to issues identified by the eCRF Helpdesk, ensuring minimal disruption to data collection and management.
• • You will prepare detailed CRF completion guidelines and study-specific data entry guidelines, and train data entry staff to ensure consistency and accuracy.
• • You will perform term coding for clinical studies, utilizing standard coding dictionaries, and raise manual queries for any uncoded terms as required.
• • Your query management responsibilities include reviewing discrepancies, evaluating answered queries, resolving them, and closing them appropriately, managing the entire data cleaning process, including manual checks and Medical Review listings.
• • You will create and test import programs for electronic data received from external vendors, ensuring seamless integration.
• • You will perform timely data integration of both CRF and non-CRF data, including data import from various external sources.
• • You will conduct reconciliation of external data, such as Serious Adverse Events (SAEs), central laboratory data, ECGs, etc., to ensure data consistency across all sources.
• • You will run and monitor study data progress reports, including query management metrics, and take appropriate actions, such as escalation or re-training, to address any deviations.
• • You will escalate any study issues identified within the study team promptly to ensure timely resolution.
• • You will define and execute the Quality Control (QC) plan, and lead and execute database release and database freeze activities, ensuring data is finalized according to protocol and regulatory requirements.
• • You will lead the DM team, coordinating other DM staff by providing clear direction regarding work assignments, scheduling, and prioritization, ensuring efficient workflow.
• • You will contribute to the input and monitoring of progress against the study project plan, escalating issues to the appropriate level for resolution.
• • You will effectively contribute to formal training sessions for new starters, sharing your expertise and best practices.
• • You will demonstrate a strong application of document management processes and procedures, ensuring all documentation is accurate and accessible.
• • You will adhere to Standard Operating Procedures (SOPs) and guidance documents, as well as applicable industry standards like ICH and GCP, in all your day-to-day activities.
• • You will make recommendations for process improvements and contribute to the development of new standards within the data management function.
• • You will develop and maintain a strong network of contacts within the study team to facilitate effective collaboration.
• • You will maintain continuous and appropriate communication with the sponsor, sharing critical and general issues as they arise.
• • You will effectively represent Data Management in internal or external meetings, such as Investigator’s Meetings, presenting data management perspectives and updates.
• • You will undertake other activities as required to support the data management function and project success.