Bachelor's Degree in science, health-related, or IT field required
8-10 years of clinical data management experience
Strong knowledge of clinical data management processes and databases
Excellent problem-solving, analytical, and communication skills
Ability to lead and mentor team members effectively
Strong attention to detail with the capability to handle multiple projects
Extensive experience in the CRO industry
Responsibilities
Manage delivery of data management services for single/multi-service projects
Lead team in project planning, execution, and communication
Provide comprehensive CDM expertise to meet customer needs
Assign tasks to ensure timely and accurate results from the team
Triage and resolve project lifecycle issues
Participate in regulatory audits and provide updates to senior stakeholders
Track and report quality and performance metrics and KPIs
Benefits
Collaborative and fast-paced team environment
Opportunity for leadership and mentorship
Engagement in process improvement initiatives
Access to training and development resources
Exposure to regulatory audits and compliance processes
Full Job Description
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 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
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
ssign 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
ssess 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
ttend 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
ctive participation in the organization and department of both in-house and external training courses
dherence 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
ssists in development and review of SOPs
ssist with special projects as designated by management
Perform 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 management
Proven knowledge of clinical data management process and clinical database systems
Excellent problem-solving, analytical, and communication skills
bility to work collaboratively in a fast-paced, team-oriented environment
Strong leadership and mentorship skills
bility 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)
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
