Assoc Data Team Lead

"Must Have :

• Experience in all aspects of clinical data management from protocol review, CRF design to database lock within expectations asper organization defined Standard operating procedures
• Experience in effective development & implementation of clinical data review / management plans / documents and document preparation
• Experience in setup and overseeing Clinical Data Management vendors, responsible for data review and delivery
• Strong knowledge and experience of EDC systems (Medidata RAVE preferred, Oracle Clinical)
• Strong Understanding and expertise in Query trend analysis, Protocol deviation review / reporting, creating study timelines, managing study deliverables as per defined timelines
• 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
• Strong knowledge of Clinical Drug Development Process, FDA / ICH guidelines and industry standard practices regarding data management, including submission requirements (e.g., New Drug Applications, Biologics License Applications, Market Authorization Applications)
• Strong analytical skills to facilitate detecting and resolving data problems encountered in clinical research studies
• Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
• Co-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 Data Management team
• 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
• Support DML in project management tasks to make sure that study is delivered successfully as per the study timelines with quality

Nice to Have :

• Knowledge of ICH-GCP guidelines regulatory guidelines / regulations.
• Solid understanding of regulations, GCPs, 21CFR Part 11 and data privacy as they apply to data handling and the use of computer systems in clinical research.
• Knowledge of basic project planning and management methods.
• CCDM certification"

"Responsibilities will include, but are not limited to :

• Draft EDC build timeline in collaboration with Data Management Lead.
• Perform DB build tasks by creating specifications for Database and Edit Checks.
• Create test scripts and complete test data entry / UAT for Coding, Site Payment, Safety Gateway.
• Collaborate with Data Management Lead and facilitate startup meetings which includes, not limited to, EDC build kick-off, Interactive eCRF Build and IRMs (Interactive Review Meeting) for database and Edit checks.
• Create and finalize study documents like Data Quality Management Plan, eCRF completion Instructions, Protocol Data Review Plan (PDRP) post study team review.
• Ensure all startup documents are completed as per SOP and filled in eTMF as per eTMF master plan.
• Plan / execute Post Production / Migration for the study (if any).
• Coordinate with Clinical Data Managers for the execution of data review tasks.
• Coordidate with external data vendors for any escalations related to any vendor data.
• Support Clean Patient Group delivery along with Clinical Data Management staff.
• Update study documents as needed during the conduct of the study
• Support DML to coduct Data Quality Review meetings.
• Provide Data Health Metrics to Data Management Lead as requested.
• Perform post lock activities, as needed.
• Support DML in project management tasks to make sure that study is delivered successfully as per the study timelines with quality.
• Filing of appropriate documents in eTMF as per eTMF master plan.
• Provide Training and mentoring to junior CDM staff."

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