Senior Clinical Data Manager

Key Responsibilities Perform all data management activities as assigned, including but not limited to: Input data management relevant sections in study outlines and study protocols. Participate in CRF design and CRF completion guidelines Fully responsible for the completion of project files for assigned projects. Ensure accurate maintenance of files and documents in their specified location according to DATACLin’s SOPs. Manage and track CRF flow and scanning, and input required data. Perform tracking, comparison, and updates. Ensure up-to-date study documents in the tracking system. Ensure that up-to-date received query responses are documented in the relevant tracking system and update the database accordingly. Build, test, and validate the study database (paper-based or EDC) Development and validation of Edit checks and the edit checks development plan. Ensure and facilitate efficient study start-up. CRF annotation DB specification Data entry guidelines. Prepare study plans (Data validation plan, validation listing, Self-evidence correction plan, and Data management Plan). Guarantee that user acceptance testing and data transfer requirements are well defined. Generate Self-evidence correction lists and update the database accordingly Discrepancy management steps, including query generation, listing, and action. (Paper-based or EDC) Perform archive procedures and prepare copies of project files as required by the Sponsor. Prepare NSAE and SAE listings for reconciliation. Database coding using coding dictionaries (e.g., MedDRA) Responsible for final Database QC as an independent Data Manager. Perform Database lock and freezing activities. Represent Data Management in audits, inspections, and meetings as required. Assist in developing and executing SOPs, departmental guidelines, and data standards to guarantee database quality control and data management compliance. Provide guidance and advice, in addition to on-the-job training, to the Data Administrator. Develop summary reports and graphs. Prepare and submit daily activities for the Data Administrator to facilitate and enhance company KPIs. Maintain a working knowledge and ensure compliance with applicable ICH-GCP, local regulatory requirements, and DATACLin SOPs and study-specific procedures. Complete routine administrative tasks promptly (e.g., metrics and Reports). Respect for the Company’s values and code of ethics. Mandatory Requirements Bachelor's degree and/or other medical qualification. 3 – 5 years of relevant experience in a Clinical data management department in a biopharmaceutical setting or, preferably, a CRO. (As per qualification and organizational needs). Knowledge of GCP, ICH guidelines, GCDMP, and CDASH/CDISC data standards. Data management in clinical research. All Data Manager activities. Knowledge / Skills Experience with medical terminology Competent in written and oral English. Good computer skills include, but are not limited to, knowledge of Clinical data management systems and MS Office products such as Excel and Word. High interpersonal skills Seeks opportunities to develop experience and knowledge. Ability to organize and plan tasks. Sense of urgency in completing assigned tasks. Must be able to work independently but seek guidance when necessary, escalating issues as required. Shows commitment to and performs consistently high-quality work. Meticulous attention to detail. Effective time management in order to meet daily metrics or team objectives Ability to work in a team environment Stress management and punctuality. Show more Show less