Data Management Lead
The Data Management Lead provides leadership and expertise in all aspects of Data Management and Database Programming. The Data Management Lead manages the delivery of all relevant data operations activities from database setup through database lock. General areas of responsibility include: coordination of the relevant Data Operations team members and their activities across all geographies, liaising with project leadership, other functional leaders (clinical, biostatistics, medical, medical writing etc.) and the client as a single point of contact to ensure that the contracted data deliverables are being met – specifically in terms of timeliness, financial management and quality.May act as Project Leader for projects involving a small number of services, where no Project Leader is assigned.Key Accountabilities:Provide leadership to ensure the project or program is completed within budget, schedule and according to contract specifications.Ensure the project/program is progressing according to quality standards, SOPs, ICH and/or other guidelines to fulfill regulations (including oversight and maintenance of relevant data operations project documentation).Must manage time, and understand financials, maintain focus on quality, balancing deadlines with ensuring high quality output.Thorough knowledge of numerous EDC systems ( DataLabs, InForm, Rave.)Thorough knowledge of the eClinical suite and additional tools and systems that can be integrated with a particular EDC system ( MyTrials, IVRS etc ) and Reporting functionality within the EDC system )Thorough knowledge of all DB set- up activities including but not limited to Database Configuration Specifications, Data Validation Specification, Protocol Deviation Specification, Data Cleaning Specification, SAE Reconciliation, UAT (User acceptance testing),Thorough knowledge of all activities during Study Maintenance and Database Lock. Review of metrics to determine risks and risk mitigation plans as requiredEffectively communicate to and manage internal project teams, external customers and third party vendors. Hold team meetings on a regular basis. Participate in client, investigator and team meetings.Ensure interdependencies are understood, anticipate potential barriers or issues, and put plan in place with appropriate countermeasures.Effectively manage contracted project delivery. Highlight issues/risks to delivery and mitigate risks for both PAREXEL and the client, developing contingency plans for the project (or providing input to PL). Accountable for quality control of project deliverables and timely delivery of projects.Manage appropriate project level resourcing of staff and staff assignments. Identify and request staff necessary for the project team.Ensure information entered into management systems is accurate and updated on a regular basis.Review metrics reports regularly, determine the cause of any project overruns, track scope of ongoing work to identify and raise CIS in a timely manner.Participate in cross functional meetings and drive initiatives, participate in Business Development and BID Defense meetings as required.Prepare, participate in and follow up on audits/inspections.Participate in meeting with Business Development / PFD / PL to understand the scope of the contract and any Master Service Agreement in place for the client.QualificationsSkills:Experience in building and leading global (virtual) teams.Ability to work effectively with and motivate virtual teams.Ability to negotiate and influence in order to achieve mutually beneficial results.Proven problem solving skills.Strong communication skills with a diplomatic approach.Strong ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail.Effective time management in order to meet objectives.Ability to conduct root cause analysis in business problem solving and process improvement development.Ability to make appropriate decisions in ambiguous situations.Excellent interpersonal, oral and written communication skills.Managerial courage, resilience, and ability to adjust to a rapidly changing environment.Excellent presentation skills.Strong customer focus, ability to interact professionally within a client organization.Knowledge & ExperienceProven record of leading project and program teams in a technical/programming or data processing environment. Robust knowledge of ICH-GCP Guidelines and local regulatory requirements.