Temporary Clinical Data Manager (21-06061)
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: Senior Manager, Clinical Data Management
Responsibilities will include, but are not limited to:
Project Management and Leadership
• 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
• 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
• Lead or support the Health Authority inspections and audits
• Provides coaching and quality oversight of junior Data Management Leads
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)
Continuous improvement initiatives
• Provides the relevant support and input to continuous improvement activities within clinical data management
• Provides support for CAPA implementation as required
Degree Requirements Bachelor’s Degree required with an advanced degree preferred
Experience Requirements At least 5 years of relevant industry experience. Project management certification (e.g. PMP) is desirable.
Key Competency Requirements
• 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
• Excellent oral and written communication skills
• Communicate effectively with senior management and cross-functional teams
• Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)]
Travel Required Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed)
How to Apply
Please send your updated resume to iris.chen@axelon.com504 total views, 0 today