Data Analyst II

Organisation Description
EMD Serono, Inc. is a leader in US biotechnology, focusing on reproductive health, metabolic endocrinology, and neurology. More than 500 people work in the world-class facilities in Rockland, MA, and approximately 250 work in the field.
Description

PURPOSE OF THE ROLE To perform project management tasks within DM for trials. To represent DM on the Trial Team. To create the Case Report Form (CRF) and key documents like the Data Management Operational Plan (DMOP) (including Data Validation Plan (DVP)), Data Management Report (DMR). To perform data cleaning activities of in house trials. To supervise Contract Research Organizations (CROs) activities.A. Trial activities:Coordination· Represent DM on the Trial Team· Review and comment as appropriate on the protocol and Statistical Analysis Plan (SAP)· Supervise CRO activities as needed· Coordinate and monitor the progress of all DM tasks on a trial and update the individuals responsible for the program as appropriate· Lead regular DM coordination meetings to communicate timelines and ensure team members are following appropriate procedures and completing tasks as scheduled· Create and maintain DM trial documentation, including the Data Management Operational Plan (DMOP) and its attachments· Train DM team on trial specific DMOP· Assist Help Desk in solving site questions or issues (EDC)· Ensure appropriate user accounts of DM staff (EDC)· Forecast and monitor trial specific DM resources· Communicate with external data providers regarding data structures and timelines for receipt of data transfers· Communicate trends in data completion to the Trial Team, and in particular to the Clinical Trial Leader (CTL) and Lead Clinical Research Associate (CRA)· Coordinate validation of data tables, screens and edit checks programs· Review and comment as appropriate on the Protocol Deviation Specification document· Write the Data Management Report at completion of trial· Review the trial report· Ensure adequate filing and archiving of relevant data and documentation, which implies transmitting all relevant trial DM documentation to the Trial Master file on an ongoing basis· Review trial specific Data Entry ConventionsCRF creation· Coordinate CRF development following general and therapeutic area standards and input of the Trial TeamDatabase creation· Create or coordinate the creation of the annotated CRF· Validate data entry screens and data tables and document the outcomeEdit check creation· Create and maintain the Data Validation Plan (DVP)· Validate edit check and protocol deviation detection programs and document the outcomeData Cleaning· Review data according to the DVP· Create listings for data review· Resolve data discrepancies, including· Review the outcome of edit check runs (for the paper process)· Create Data Correction Forms (DCFs) and send to the sites· Review DCF answers for adequacy and (for the paper process) implement the answer in the clinical database and the CRF, and (for the EDC process) close/re-issue as appropriate· Assist with QC of CRF/DCF (for the paper process) or Portable Document Format (PDF) (for the EDC process) data vs. database· Communicate data issues to the team to ensure resolution· Review and reconcile non-CRF data with clinical database and ensure readiness for analysis· Freeze/Unfreeze and lock/unlock specific eCRF screens (for the EDC process)· Contribute to the protocol deviation data management, including detection of deviations and finalizing the list· Review findings from trial Biostatistician/Statistical programmer dry run listings and take appropriate actions (raise query or clarify to Biostatistician/ Statistical programmer) · Declare validated and ready to lock database· Integrate randomisation schema in conjunction with Biometrics
EDUCATION/LANGUAGES Basic Science/Bachelor of Science degree in health related field or equivalentExcellent knowledge of English PROFESSIONAL SKILLS && EXPERIENCE Minimum of two years experience in clinical data management in the pharmaceutical/biotechnology industry.Familiarity with ClinTrial, InForm, and/or SQL a plusUnderstanding of relational database designProficient Computer Skills e.g. word processing, spreadsheetsKnowledge of medical terminology requiredExcellent knowledge of regulations and guidance with regard to clinical development and the systems used in this context PERSONAL SKILLS && COMPETENCIES Excellent written, verbal and organizational skillsIndividual must be detail oriented and have strong prioritization skillsExcel in planning and self coordinationAbility to handle multiple projects and stressful situationsProblem solver, critical thinker