Data Management Lead II
Company Name:-
Parexel
Job Location:-
Bengaluru, Karnataka
Job Summary:-
Job Purpose:
The Senior Data Management Lead provides leadership and expertise in all aspects of Data Management.
Develop and manage timelines for study data deliveries, including Go-Live, Interim Deliveries and Final DB Lock.
Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.
) across all geographies.
Data Management single point of contact to ensure that the contracted Data Management deliverables are being met – specifically in terms of timeliness, financial management and quality.
The Senior Data Management Lead can competently and independently lead large, complex projects and/or programs with little to no guidance from their Line Manager and/or Subject Matter Experts.
Senior DMLs may act as a mentor for ADMLs, DMLs and other Senior DML peers.
May act as Project Leader for projects, involving only Global Data Operations services.
Key Accountabilities:
Cross-functional DM leadership through Database Set up, Conduct and Study Close-Out -Manage and coordinate the integration and utilization of all ancillary systems as appropriate.
Highlight issues/risks to delivery by understanding interdependencies.
Define mitigations and drive to resolution with cross-functional stakeholders as part of Risk Management Plan.
Review and analyze metrics to derive meaningful summary of study health and trends.
Review of the Master Services/Service Level Agreement, and/or contract to manage toward sponsor-specific metric targets/Key Performance Indicators.
Host and attend cross-functional meetings.
Prepare Meeting Agendas and Minutes, comply to action and decision logs.
Bid Pursuits and Proposals -Prepare for and participate in study or program-level Bid Pursuit preparation meetings.
Portray Parexel’s technical and operational expertise and capabilities, and tailor to meet sponsor’s specific needs.
Create relevant slides with cross-functional Global Data Operations input as appropriate.
Present with confidence and as a cohesive Parexel team with other functions.
Project Quality Management and Compliance-Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.
Maintain inspection-ready Trial Master File.
Identification of quality issues, ensuring they are r
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