Clinical Data Management Team Lead

Assoc Data Team Lead

"
• Bachelor's Degree required. Life sciences, Pharmacy or relevant fields preferred.

• 6 years of experience in managing end-to-end Clinical Data Management tasks. "

"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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