Temporary Clinical Data Manager (20-16736)
Job Description
“This role is currently work-from-home and will move to the office environment after the COVID-19 restrictions are lifted.”
Job Description: Job Title: Clinical Data Management Associate
• Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects
• Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
• Responsible for end to end clinical data management activities and serves as a primary point of contact for internal and external study team members with minimal oversight from senior data management resources
• Provides strong quality and project oversight over third party vendor responsible for data management deliverables
• Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes
• Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
• Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency , quality and completeness
• Represents DM on cross-functional project teams & submission Teams
• Provides support to Health Authority inspections and audits
• Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
• Represents Data Management on cross-functional project teams
• Support’s the Health Authority inspections and audits
FSP/CRO/Vendor Oversight
• May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)
Bachelor’s Degree required
At least 3 years of relevant industry experience
• Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
• Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management
• Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection
• Strong project management; Exhibits expertise in metrics analysis and reporting methodologies
• Strong oral and written communication skills
• Communicate effectively with senior management and cross-functional teams
How to Apply
Please send your updated resume to iris.chen@axelon.com294 total views, 0 today