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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