Data Management Lead I and II - FSP (Remote)

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

- The Data Management Lead l provides leadership in all aspects of Data Management. Manages 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’s 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 Data Management Lead l works under the guidance of their Line Manager and may receive additional direction/support from an experienced Data Management Lead or Subject Matter Experts. They may work as a co-DML with an experienced DML or work independently on less complex trials.

- The Data Management Lead II develops and manages timelines for study data deliveries, including Go -Live, Interim Deliveries, and Final DB Lock. Collaborate with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies. Acts as the Data Management's 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 Data Management Lead II works with minimal guidance from their Line Manager and/or Subject Matter Experts. DMLs may act as a mentor for ADMLs or other DML peers. May act as Project Leader for projects involving only Global Data Operations services.

Key Accountabilities:

Accountability Supporting Activities 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. Support 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 Agreement, 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

• Support experienced DML in Bid Pursuit preparation meetings.

 • Provide input on DM slides, as appropriate.

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

 • Support and implement Corrective/Preventive actions for study, and work toward alignment across Parexel as appropriate.

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

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

• May support other functions as appropriate to provide meaningful functional feedback on the initiative.

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

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.

Skills:

 • Written and oral fluency in English

Knowledge and Experience:

• Experience in clinical research industry or similar field

• Proven record of coordinating and supporting project teams

• Basic understanding or willingness to learn and apply Parexel financial tools, reports and processes for management of project financials with regards to forecasting, revenue recognition, scope of work and department budget for assigned projects

 • Basic understanding of or willingness to learn Clinical Study Team roles outside of Data Management

• Full understanding or willingness to learn and apply relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures

 • Awareness of/or willingness to learn SDTM/CDISC/CDASH standards

• Awareness/potential prior experience in Clinical Trial/Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products.

• Demonstrates technical aptitude

Education:

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