Senior Data Management Lead - FSP (Remote)

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:

Accountability 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 raised in relevant system and closed according to requirements.

• Prepare for and participate in audits and inspections for internal, sponsor, and regulatory agencies.

• Drive and implement Corrective/Preventive actions for study, and work toward alignment across Parexel as appropriate - share lessons learned across multiple projects within a program or therapeutic area.

Project Financial and Resource Management

• Ensure appropriate project level resourcing of staff and staff assignments. Identify and request functional staff necessary for the project team.

• Regular review and update of DM resources to ensure alignment with contracted budget, project resource forecast, actuals, and demand, utilizing the necessary systems and tools.

• Determine and resolve the root cause of DM-related project variance in a timely manner, including negotiating/raising changes in scope.

Company Initiatives

• Provide Data Management functional input, considering the impact of the initiative and the impact on Data Management and Parexel as a whole.

• Guide and lead other functions as appropriate to provide meaningful functional feedback on the initiative.

• Ensure Parexel-requested information entered in management systems is accurate and regularly updated.

• Participate in creation/review of SOP process and/or templates - provide input as a Subject Matter Expert (SME) where necessary.

Training

• Maintain training compliance as per Job Roles assigned, including On-the-Job training.

• Deliver Project Specific Training to internal DM team.

 • Address training needs, as per Development Goal/s identified.

• Deliver On-the-job training where needed/requested.

 • May deliver instructor-led training.

Skills:

 • Written and oral fluency in English

Knowledge and Experience:

• Substantial experience in clinical research industry

 • Proven record of leading project and program teams

• Advanced understanding and application of Parexel tools, reports and processes for management of project financials with regards to forecasting, revenue recognition, scope of work and department budget for assigned projects.

• In-depth understanding of Clinical Study Team roles outside of Data Management

• Full understanding and application of ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures

 • Awareness of SDTM/CDISC/CDASH standards

 • Advanced technical skills including, but not limited to the knowledge of Clinical Trial/Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products.

Education:

• Bachelor’s degree and / or other qualifications in a science or clinical related industry