Clinical Data Manager II/Senior Clinical Data Manager

• Review and query clinical trial data according to the Data Management Plan

• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM

• Run patient and study level status and metric reporting

• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency

• Coordinate SAE/AE reconciliation

• Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables

• May assist with SAS programming and quality control of SAS programs used in the Data Management department

• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders

• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project

• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities

• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings

• May review Request for Proposals (RFP), proposals, provide project estimates

• Provide leadership for cross-functional and organization-wide initiatives, where applicable

• Trains and ensures that all data management project team members have been sufficiently trained

• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues

• May present software demonstrations/trainings, department/company training sessions, present at project meetings

• May require some travel

• Perform other duties as assigned

Qualifications:

• Bachelors and/or a combination of related experience

• 8+ years’ experience as a Sr. Clinical Data Manager or 5+ Years as a Clinical Data Manager II working for a Clinical Research Organisation, Pharmaceutical or Biotech company

• Set up and Database migrations experience

• Oncology experience preferred

• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook

• Excellent organizational and communication skills

• Professional use of the English language; both written and oral

• Experience in utilizing various clinical database management systems

• Broad knowledge of drug, device and/or biologic development and effective data management practices

• Strong representational skills, ability to communicate effectively orally and in writing

• Strong leadership and interpersonal skills

• Ability to undertake occasional travel

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