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Lead CDM Contractor

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Newton, MA
$55.00 - $75.00
Job Type
Dec 08, 2017
Job ID
Work in conjunction with external vendors, CRO(s), to Review/Create (electronic) Case Report Forms and annotated Case Report Forms per Protocol
Review validation of database structure (DVS), data capture screens, code lists, edit checks, listings and other functions in EDC (e.g. User Acceptance Testing)
Develop data transfer agreements and specifications with various vendors
Review eCRF completion guidelines, data management plan (DMP), data validation specifications (DVS, e.g. edit checks), SAE Reconciliation Plan, Data Cleaning Plan and other DM related documentation in conjunction with CRO(s)
Assist CRO(s) with cleaning data for Interim Analysis, Database lock, and any add hoc requests.
Liaise with external vendors (Central Labs) in support of timelines and data related deliverables; may also liaise with clinical monitoring in the data management function
Perform all aspects of Data Management as related to processing and QC of the data, monitor study status, (e.g. Enrollment, eCRFs, Query Aging, etc.) and provide status reports to the team throughout the study
Responsible for working with database build vendor to develop new EDC databases and subsequent revisions.
Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports and input from project team members.
Review and approve study timelines
Monitor timelines and ensure that clinical data management timeline are met with quality
Use industry standard conventions, tools, references and process in support of the coding of Medical History, Adverse Events and ConMeds/ConProcs
Ensures all DM procedures are executed with a high attention to detail, accuracy and timelines
Review and provide feedback on Protocols, Statistical Analysis Plans and CSRs
Represent Karyopharm DM on project teams, at Face-to-Face Meetings, Conferences, etc.
Co-create and review DM SOPs and Work Instructions in accordance with current GCP and ICH guidelines

Work in conjunction with internal and external Clinical Operations, Research, Data Management and other operational departments to ensure accurate, efficient, and complete data collection
Ensure adherence to Data Management standards.
Ability to travel (~travel time 25%, Global Travel)
Other duties as assigned 

Computer Skills: 
Proficient in Microsoft Office applications (PowerPoint, Microsoft Word, Microsoft Excel, etc.), Internet software, E-mail
Experience with Electronic Data Capture (EDC) systems
Experience with SAS (Base, Stats, Macro, etc.)
Experience with CDISC SDTM/CDASH 
B.S./B.A. in Science related field
5 to 8 years of data management experience in the pharmaceutical or biotechnology industry. Minimum 4 years in a Lead CDM capacity
Highly organized and detail-oriented with effective planning and strong verbal and written communication skills
Flexibility and agility to adapt to changing scope of work, able to propose thoughtful solutions to challenges and issues, proactively implement solutions, and communicate effectively with colleagues
Experience/knowledge of GCP and ICH guidelines