Position Summary:
The Senior Clinical Data Associate provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position may perform database development and testing, as well as additional data management activities.
Essential functions of the job include but are not limited to:
- Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner
- May perform data entry for paper-CRF studies, as needed
- May perform quality control of data entry
- May provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects, as needed.
- Assist in developing CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
- May assist in building clinical databases
- Conduct database build UAT and maintain quality controlled database build documentation. May oversee overall quality of the clinical database.
- 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
- 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
- May 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
- 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:
Minimum Required:
- 5+ years’ experience
- Bachelor's and/or a combination of related experience
Other Required:
- 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.
- 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:
Demonstrates strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, as well as the ability to implement and drive outcomes
Competencies:
- Motivates project team members to meet timelines and project goals
- Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
- Resolves project related problems and prioritizes workload to meet deadlines with minimal support
- Exhibits a high degree of self-motivation, and can work and plan independently as well as in a team environment
- Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills
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