Clinical Data Analyst in Burlington, MA at Volt

Date Posted: 10/26/2018

Job Snapshot

Job Description

Volt Workforce Solutions is looking for a Clinical Data Analyst for a 6 mo contract with our client in Burlington, MA 

Working under general supervision, the Clinical Data Analyst is responsible for all aspects of data management activities in support of assigned clinical studies. These activities help to ensure high quality data is achieved in support of analysis for regulatory submissions, safety monitoring and publications. Ensures that Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP) and established processes are followed. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises judgment in planning, organizing and performing work; monitors performance and reports status within area of responsibility. Ensures that quality of services meets internal and external customer requirements.

Job Duties:

  • Performs all data management activities for assigned studies, as appropriate
    • Protocol and Statistical Analysis Plan (SAP) review and input
    • Case Report Form (CRF) development and maintenance
    • Edit Check specifications development and maintenance
    • Data Management Plan development and maintenance
    • Data Quality Checks and discrepancy management
    • Analyzes data, identifies trends; prepares data tables for reports
    • Database setup testing and Edit Check programming testing
    • External data handling
    • Device reconciliation and tracking for investigational product
    • Participate in Post Market Surveillance reporting as appropriate
    • Additional study specific activities
  • Ensures that all data management activities for assigned studies are completed on time and with high quality or escalates as appropriate
  • Communicates well with peers, study teams and management as appropriate to support studies and goals
  • Participates in efforts to improve Data Management processes, as needed/assigned
  • Represents the Data Management group at study team meetings
  • May represent the Data Management group on cross-functional task forces
  • May train and mentor other Clinical Data Associates (CDAs) and Clinical Data Coordinators (CDCs) on certain tasks
  • Applies best practices and established standards
  • Serves as a liaison between the study team and clinical data operations
  • Is a Subject Matter Expert (SME) in one or more areas within Data Management
  • Has a general understanding of the clinical trial process and regulations that apply, engages in relevant professional associations or societies, and seeks continuing
  • education about SJM devices and therapies.
  • Communicates and collaborates with all levels of employees, customers, contractors, and vendors.
  • Provides input to departmental Standard Operating Procedures (SOPs), Departmental Work Instruction (DWIs), and guidelines.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, International Conference on Harmonisation (ICH), ISO 14155, other regulatory requirements,
  • applicable company policies, operating procedures and processes.
  • Performs other related duties and responsibilities, on occasion, as assigned.

General Qualifications

  • Bachelor's Degree in Computer Science, Health Sciences, Informatics, related field, or equivalent.
  • Typically a minimum of four plus years’ experience working in a clinical research environment, experience to include a good understanding of clinical data
  • management processes.
  • Good organizational and project management skills, as well as attention to detail.
  • Highly skilled with MS Office, especially Excel, Word, Publisher and Powerpoint.
  • Strong ability to work with Clinical Data Management Systems.
  • Understands databases; good technical skills in querying and analyzing data (SQL, Oracle, SAS or equivalent).
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Ability to maintain regular and predictable attendance.

Please apply to position or contact Debbie Linville at 317-599-4893 for any questions and more details regarding this position.

Volt has been serving some of the nation's strongest companies for over 60 years. As a Volt employee, you can expect the highest level of on-site support. We have a long-standing tradition of developing lasting and mutually beneficial relationships with its employees.

Volt is an Equal Opportunity Employer