Reports to Senior Technical Global Team Leader of data management
May work as back up to Sr. Technical Global Team Leader of data management with India studies as needed.
Manages the Data Managers and eCRF Developers/Database Designers on study related tasks with -India site.
Provides additional training and mentors Data Managers.
Leads DM activities on assigned studies including performing activities from set-up for EDC studies to database freeze.
Monitors and adheres to study timeline as it relates to assigned activities.
Creates, reviews, and finalizes SVWT document.
Schedules SVWT meeting and drafts study setup timings as agreed upon by the clinical study sub-team (CSST).
Schedules screen reviewing meetings with CSST and eCRF developer.
Reviews and approves screens with input from CSST.
Reviews and approves Annotated eCRF.
Creates, sends for review, and approves eCRF completion guidelines.
Creates DVS and UAT test scripts in conjunction with eCRF developer; sends for review, and final approval.
Maintains eCRF Development Issue Log.
Performs DVS UAT documenting findings on the eCRF Development Issue Log.
Creates and sends Deployment UAT document for review and approval
Runs and reviews data listings and reports.
Performs in-steam data cleaning activities: reviews subject data, reviews auto query responses and closes auto-queries, reviews and processes candidate queries, generates manual queries, and freezes subject casebooks.
Coordinates all coding activities from set up for final approval at study completion.
Performs database closeout activities: reconciles SAE, obtains medical term coding approval, reconciles external data, freezes casebooks, and declares database complete and frozen.
Designs, reviews and approves paper study documents.
Attends Data and Programming Operations, CSST, and other meetings as needed.
5-7 years of experience into Data Management activities (DE Screen Testing, Edit Check Creation and Testing, Query Management, Data Entry guidelines creation, DB Lock/Unlock) in the pharmaceutical industry or a clinical/health-related research organization. Understanding of clinical trial methodology and GCP. Experience and understanding of at least one clinical data management system (e.g. Clintrial, Oracle Clinical). Good verbal and written communication skills. Ability to work on multiple projects, plan, organize and prioritize activities. Knowledge of Framemaker, PL/SQL, Inform and/or EDC systems an additional plus.