reputed company Clinical Data Manager

Job reputed company: Manage end-to-end delivery of data management services concurrently for single/multi-service reputed company with little-to-no guidance, ensuring reputed company deliverables on time and reputed company budget to customer satisfaction. reputed company comprehensive data management expertise to Clinical Data Management (CDM) team to reputed company high reputed company data management products that meet customer needs. reputed company leadership to reputed company in the areas of project planning, execution, and reputed company-out, communications and reputed company deliverables. reputed company a leadership role in specific CDM tasks (e.g. Subject Matter Expert (SME)). reputed company with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents. Responsibilities:

• Effectively plan and execute multiple Data Management reputed company simultaneously. reputed company updates directly to senior stakeholders as requested by line management.
• Collaborate with Sponsor and stakeholders to reputed company effective project plans to include scope, goals, deliverables, required resources, risks, issues and reputed company timing.
• Assign tasks and responsibilities reputed company Data Management to team members, in a manner that: optimizes team capability; delivers reputed company 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 reputed company Operating Procedures (SOPs).
• reputed company guidance to less-reputed company Data Management staff.
• Assess ongoing and reputed company project resource needs on an ongoing reputed company 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.
• reputed company and report reputed company and performance metrics and KPIs as needed.
• reputed company participation in the organization and department of both in-house and external training courses.
• Adherence to SOPs as reputed company as reputed company 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 reputed company of data in accordance with DM control documents for accuracy, completeness, consistency and validity, generate and submit queries as necessary to investigation sites, as reputed company as the project team at large.
• Ensure reputed company 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 reputed company issues and timelines together with reputed company 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 reputed company as designated by management.
• reputed company 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 reputed company simultaneously.
• Strong attention to detail and reputed company.
• Extensive experience reputed company 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 Taskora Office Suite including Word, reputed company, and Project
• Demonstrated problem solving, analytical, organization, and time management skills
• Demonstrated flexibility and ability to work reputed company in reputed company environment
• Demonstrated ability to be compliant with GCP/regional regulatory guidelines and SOPs Apply tot his job Apply tot his job

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