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Responsibilities:

• Function as internal Study Data Manager, overseeing all data management activities performed by CROs including generation and review of metric status and patient tracking reports; ensuring major DM deliverables and milestones are met.
• Reviews and manages key documents such as data management plans, guidelines for CRF completion, data review, SAE reconciliation, Vendor Oversight, TMF plans, and data audits.
• Maintains protocol level documentation of data management activities.
• Reviews draft protocol and provides input to ensure that the data collection, databasing and reporting requirements can be met.
• Following CDISC conventions, oversees or performs eCRF design and annotation, database design specifications; Develop or oversee CRO generation of data edit check specifications (DVS); Participate in user acceptance testing (UAT) of the clinical database, including edit check testing
• Leads development of CRF completion instructions.
• Co-ordinates User Acceptance Test (UAT) activities for the clinical database..
• Liaises with the CRO data management team to define and implement edit checks on the data.
• Tracks and monitor the flow of the data from the source to the CRO and/or Harpoon.
• Leads internal study team in data review; Perform data review for quality issues and general data trends; generate queries as necessary.
• Work with programming to produce in-process data reports and data visualization tools to facilitate decision making on clinical trials (e.g., safety reviews). Provide input on standard tools and reports.
• Study DM liaison with cross-functional team members and external vendors to ensure completion of all timelines and study-related tasks; Ability to work independently as well as within a cross-functional team environment.
• Performs review and appropriate quality checks of data presentations.
• Supports and responds appropriately to any audit (notably on clinical data management process or products), internal or external.
• Participates in the development of processes for new initiatives and refine existing processes related to data management.
• Participates in SOP development, training, process mapping, implementation of standardized work processes and other departmental activities.

Requirements:

• Preferred: 6+ years in a pharmaceutical/biotech or CRO setting; global/international experience a plus.
• Bachelor's Degree in a scientific discipline (Advanced degree preferred).
• Experience supporting phase 1 to 3 clinical trials. Oncology experience preferred.
• Knowledge and experience in EDC, key technologies (eg, IXRS) and industry standards including regulatory regulations, ICH-GCP guidelines, and CDISC-conformant clinical data standards with understanding of SAS, SQL and/or other clinical programming applications.
• Experience working in EDC systems (Rave).
• Solid understanding of clinical drug development process and knowledge of regulatory requirements and ICH/GCP guidelines.
• Strong understanding of medical data coding classification systems, e.g., MedDRA, WHO-Drug.
• Proficiency with MS Word, Outlook, and PowerPoint.
• Experience in core DM activities (e.g., DM Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries). SCDM Certification a plus.
• Strong skills in collaboration, communication, organization, attention to detail and multi-tasking.
• Sound analytical and problem-solving skills; ability to act with a consistent sense of urgency.
• Ability to prioritize and to adapt quickly to changing business conditions with a positive attitude
• Willing to travel if required.
• Ability to prioritize workload and meet deadlines, demonstrate effective use of time and handle multiple assignments simultaneously.
• Capable of proactively identifying project challenges and risks and proposing appropriate and strategic solutions to issues.