Remote Manager Data Management

Summary

Join Precision for Medicine as a Manager, Data Management to line manage a team of Clinical Data Associates. The role involves managing the day-to-day activities of the Data Management function, providing oversight and leading activities for data management projects, and coordinating interdepartmental and client communication.

Requirements

• 5+ years minimum experience
• Bachelors and/or a combination of related experience
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
• Able to handle a variety of clinical research tasks
• 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 leadership and interpersonal skills
• 1+ years of leadership experience

Responsibilities

• DM Oversight of sponsor programs, ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner for all studies for these clients
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality
• May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• May assist in building clinical databases
• May conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed
• May review and query clinical trial data according to the Data Management Plan
• May perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• May run patient and study level status and metric reporting. Oversee the development requirements and frequency of report delivery
• May perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• May 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
• 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, database management, applications development and SAS programming activities
• Provide technical and operational guidance and direction, checking output of project work, ensuring deliverables are met and performance and professional behaviour management
• Attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• Reviews Request for Proposals (RFP), proposals, provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• 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
• Present software demonstrations/trainings, department/company training sessions, present at project meetings

Preferred Qualifications

• Experience in a clinical, scientific or healthcare discipline
• Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
• Oncology and/or Orphan Drug therapeutic experience