Principal Clinical Data Manager

Job Summary: 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 satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out, communications and milestone deliverables. Perform a leadership role in specific CDM tasks (e.g. Subject Matter Expert (SME)). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents. Responsibilities:

• Effectively plan and execute multiple Data Management projects simultaneously. Provide updates directly to senior stakeholders as requested by line management.
• Collaborate with Sponsor and stakeholders to develop effective project plans to include scope, goals, deliverables, required resources, risks, issues and milestone timing.
• Assign 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 business.
• Ensure 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 staff.
• Assess ongoing and future project resource needs on an ongoing basis with feedback to Line Management.
• Triage and resolve issues throughout project lifecycle.
• Ensure that project team members’ performance supports project budget and delivery requirements.
• Effectively manage project scope by ensuring any changes to scope are documented and approved through appropriate change management processes.
• Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections.
• Attend regular meetings with the sponsor and/or project team, for discussions relating to data management issues and provides status updates for the project.
• Track and report quality and performance metrics and KPIs as needed.
• Active participation in the organization and department of both in-house and external training courses.
• Adherence to SOPs as well as current ICH-GCP guidelines and other applicable standards demanded by the Regulatory Authorities.
• Coordinate and manage training for Investigators, Data Coordinators and CRAs on the selected Data Systems for Data Processing.
• Ensure 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 large.
• Ensure all clinical data management tasks are complete prior to database lock.
• Produce 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 achieved.
• Identify and recommend process improvements and standards to department management and implements approved process improvements.
• Assists in development and review of SOPs.
• Assist with special projects as designated by management.
• Perform other duties as assigned by management.

Experience:

• Proven knowledge of clinical data management process and clinical database systems
• Excellent problem-solving, analytical, and communication skills.
• Ability to work collaboratively in a fast-paced, team-oriented environment.
• Strong leadership and mentorship skills.
• Ability to work independently and manage multiple projects simultaneously.
• Strong attention to detail and quality.
• Extensive experience within the CRO industry
• Extensive knowledge of Clinical Data Management System(s), including Electronic Data Capture system(s)

Education/Qualifications:

• BS/RN in Life Sciences and/or combination of education and experience
• Minimum of 8-10 years experience in clinical data management
• Strong oral and written communication skills
• Effective working knowledge of Microsoft Office Suite including Word, Excel, and Project
• Demonstrated problem solving, analytical, organization, and time management skills
• Demonstrated flexibility and ability to work well in a team environment
• Demonstrated ability to be compliant with GCP/regional regulatory guidelines and SOPs

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