Principal Clinical Data Manager

Responsibilities Manage end-to-end delivery of data management services concurrently for single/multi-service projects with little-to-no guidance, ensuring quality deliverables on time and within budget to customer satisfactionProvide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needsProvide leadership to the team in the areas of project planning, execution, and close-out, communications and milestone deliverablesPerform a leadership role in specific CDM tasks (e.gSubject Matter Expert (SME))Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documentsEffectively plan and execute multiple Data Management projects simultaneouslyProvide updates directly to senior stakeholders as requested by line managementCollaborate with Sponsor and stakeholders to develop effective project plans to include scope, goals, deliverables, required resources, risks, issues and milestone timingAssign tasks and responsibilities within Data Management to team members, in a manner that: optimizes team capability; delivers timely and accurate results; and supports the needs of the businessEnsure that assigned team executes Data Management functions in accordance with CRO and/or Sponsor Standard Operating Procedures (SOPs)Provide guidance to less-experienced Data Management staffAssess ongoing and future project resource needs on an ongoing basis with feedback to Line ManagementTriage and resolve issues throughout project lifecycleEnsure that project team members' performance supports project budget and delivery requirementsEffectively manage project scope by ensuring any changes to scope are documented and approved through appropriate change management processesParticipate in and/or contribute to Sponsor and/or Regulatory audits/inspectionsAttend regular meetings with the sponsor and/or project team, for discussions relating to data management issues and provides status updates for the projectTrack and report quality and performance metrics and KPIs as neededActive participation in the organization and department of both in-house and external training coursesAdherence to SOPs as well as current ICH-GCP guidelines and other applicable standards demanded by the Regulatory AuthoritiesCoordinate and manage training for Investigators, Data Coordinators and CRAs on the selected Data Systems for Data ProcessingEnsure quality of data in accordance with DM control documents for accuracy, completeness, consistency, and validity, generate and submit queries as necessary to investigation sites, as well as the project team at largeEnsure all clinical data management tasks are complete prior to database lockProduce and/or coordinate reports and listings for team reviews and DSMBs (Data Safety Monitoring Boards)Ensure the project team and the sponsor is kept informed of all issues and timelines together with quality and performance achievedIdentify and recommend process improvements and standards to department management and implements approved process improvementsAssists in development and review of SOPsAssist with special projects as designated by managementPerform other duties as assigned by management. Requirements: Bachelor's Degree in a science, health related, or information technology field required.Minimum of 8-10 years' experience in clinical data managementProven knowledge of clinical data management process and clinical database systemsExcellent problem-solving, analytical, and communication skillsAbility to work collaboratively in a fast-paced, team-oriented environmentStrong leadership and mentorship skillsAbility to work independently and manage multiple projects simultaneouslyStrong attention to detail and qualityExtensive experience within the CRO industryExtensive knowledge of Clinical Data Management System(s), including Electronic Data Capture system(s)Strong oral and written communication skillsEffective working knowledge of Microsoft Office Suite including Word, Excel, and ProjectDemonstrated problem solving, analytical, organization, and time management skillsDemonstrated flexibility and ability to work well in a team environmentDemonstrated ability to be compliant with GCP/regional regulatory guidelines and SOPs