Essential Functions:
- Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and timely task performance.
- Perform data entry for paper-CRF studies, as needed.
- Perform quality control of data entry.
- Provide input into timelines and ensure clinical data management deadlines are met with quality.
- Assist in developing CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.
- Assist in building clinical databases.
- Conduct database build UAT and maintain quality controlled database build documentation.
- Assist in specifying requirements for all edit check types e.g., electronic, manual data review, edit checks, etc.
- Responsible for creating, revising, appropriate versioning and maintaining data management documentation.
- Train clinical research personnel on the study specific CRF, EDC, and other project-related items as needed.
- 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.
- Assist with coordinating SAE/AE reconciliation.
- Assist with liaising with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables.
- 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.
- Assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs), if required by the project.
- Assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities.
- Train and ensure 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, and present at project meetings.
- Perform other duties as assigned.
Qualifications:
Minimum Required:
- 4+ years’ experience within Data Management
- Bachelor’s degree within a scientific/science background and combination of related experience
Other Required:
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
- Ability to handle a variety of data management tasks and oversight.
- Excellent organizational and communication skills.
- Professional use of the English language; both written and oral.
- Basic knowledge of drug, device, and/or biologic development and effective data management practices.
Preferred:
- 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.
Skills and Competencies:
- Strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, with the ability to implement and drive outcomes.
- Ability to motivate project team members to meet timelines and project goals.
- Focus on continuous improvement, making proactive assessments on process efficiency.
- Ability to resolve project-related problems and prioritize workload to meet deadlines with minimal support.
- High degree of self-motivation, and capability to work and plan independently as well as in a team environment.
- Professionalism, punctuality, ability to deliver on commitments, understanding of the service culture, and positive interactions with customers and teammates, including good interpersonal skills.
