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Senior Manager, Clinical Data Management

Summary

The Senior Manager is responsible for independently leading multiple, high volume and extremely complex studies while also mentoring more junior staff. They will independently lead, with quality, all clinical data management activities within an assigned study or studies, including direct contact and responsibility for functional, administrative and financial oversight of assigned studies.

Responsibilities

• Effective in identifying potential Out of Scope activities prior to vendor beginning work, modify/update study contracts while staying within budget, with guidance by a Director of CDM as needed
• Provide leadership and direction to junior staff and peers, by mentoring, training and guiding a study team to meet study deliverables within the ICH/GCP guidance.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports and input from project team members.
• Ability to recognize, evaluate and develop plans to mitigate risk as needed from study initiation to study close-out.
• Perform all aspects of Clinical 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 and Director CDM throughout the study.
• Work in conjunction with external vendors, CRO(s), CDM Team, Clinical Team to Review/Create (electronic) Case Report Forms and annotated Case Report Forms per Protocol for assigned study (s)
• Co-create and review DM SOPs and Work Instructions in accordance with current GCP and ICH guidelines.
• 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), providing feedback and guidance where necessary.
• Assist CRO(s) with cleaning data for Interim Analysis, Database lock, and any ad 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.
• Develop data transfer agreements and specifications with various vendors.
• Review validation of database structure (DVS), data capture screens, code lists, edit checks, listings and other functions in EDC (e.g. User Acceptance Testing (UAT)).
• Review and provide feedback on Protocols, Statistical Analysis Plans and CSRs.
• Represent CDM on project teams, at Face-to-Face Meetings, Conferences, etc.
• Work in conjunction with internal and external Clinical Operations, Research, Medical Monitoring, Medical Writing, Clinical Data Management and other operational departments to ensure accurate, efficient, and complete data collection.
• Use industry standard conventions, tools, references and processes in support of medical coding.
• Ensures all CDM procedures are executed with high attention to detail, accuracy and timelines
• Ability to create, review and approve study timelines.
• Monitor timelines and ensure that clinical data management timelines are met with quality
• Ensure adherence to Data Management standards.
• Other duties as assigned.

Qualifications

• 10-12+ years of experience
• Experience in Oncology
• Experience in Medidata Rave
• Experience in elluminate preferred

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