Project Manager, Clinical Data Management

Overview

KAI Research, an Altarum company, is seeking to hire a Project Manager, Clinical Data Management professional, to work full-time in our Data Management and Data Standards group. With the commitment and drive you would bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. 

This position is responsible for management of all aspects of clinical data management tasks from study start-up to database close out and analysis if needed. 
With limited supervision from senior staff, acts as project team leader for data management and data standardization projects, you will work collaboratively with Biostatistics, Data Management, and Operations teams. By joining KAI Research, you will further our mission to exceed our client expectations using cutting edge technology in clinical research. This position will be located in Rockville, MD.

Responsibilities

Essential Duties:

  • Manages the data quality and data management activities at the project or study level in support of the overall operation and business need

  • Manages data management related timelines and resources.  Coordinates deliverables within the overall project team timelines.Ensures all project data management deliverables meet the pre-defined criteria and timelines
  • Acts as the Data Management Lead for multiple projects:

        • Reviews protocols and Statistical Analysis Plans (SAP)

        • Manages all aspects of case report form (CRF) design and development (paper or eCRF)

        • Develops specifications for standard edit checks, data listings, and reports

        • Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs

        • Reconciles electronic data transfers from vendor to Sponsor

        • Leads and coordinates database and web site QC processes

        • Reviews data for accuracy, completeness, and consistency

        • Trains junior team members on all data management tasks such as the processes to track and resolve queries, and the reconciliation of Protocol Deviations and Adverse Events

  • Oversees all communication with clinical sites and external vendors
  • Provides status updates to Senior Management and Clients. Attends and leads project team meetings
  • Provides support to internal and external staff in the use of Clinical Data Management systems
  • Oversees and supports the development of Data Management Plans (DMPs), data entry instructions and guidelines, coding manuals, and other data documentation manuals

  • Develops data standard conventions and guidelines and ensures they are applied consistently across projects

  • Develops, applies and promotes consistent Data Management standards through standard processes and SOPs

  • Along with other PMs and CDMs, leads the effort to improve KAI’s best practices, Standard Operating Procedures, and internal standards for data management
  • Leads and supports therapeutic/disease specific common data element development and implementation
  • Supports FDA CDISC submission
  • Assists with drafting data management verbiage for responses to proposals (RFPs) for government and private sector contracts

Qualifications

Qualifications

  • Bachelor's degree in life sciences or related field; Master’s degree in a health-related field or Statistics preferred
  • Minimum 3+ years of data management experience, and CDM certification preferred; some biostatistics knowledge preferred; SAS programming is a plus

  • Up to two years of project management with a focus in data management

  • Strong understanding of clinical trial data; good understanding of relational database components and theory; knowledge of XML is a plus

  • Well-versed in all aspects of data management and clinical IT systems from study start-up to database lock
  • Experience with Electronic Data Capture systems and commercial Clinical Data Management Systems
  • Knowledge of GCP, ICH, and FDA regulatory requirements as they apply to clinical data management
  • Knowledge of CDISC standards and the therapeutic/disease specific common data elements; hands-on experience using these standards (i.e., CDISC, NCIP caDSR, etc.) is a plus
  • Proficient in Microsoft Office (Word, PowerPoint, Access)
  • Mastery of Microsoft Excel
  • Ability to lead small and large project meetings
  • Self-motivated, detail-oriented, with strong analytical and problem solving skills
  • Excellent verbal and written skills, good organizational, interpersonal, and team skills

  • High energy with ability to work on multiple studies, to complete deliverables on time, and to adjust priorities in a fast-paced environment

 

ABOUT KAI RESEARCH: 

  • KAI Research's dynamic work environment emphasizes integrity, personal commitment, and teamwork. In addition to the meaningful and challenging work, KAI offers an outstanding benefits program that includes paid time off, tuition reimbursement, 401k (5% employer contribution), a flexible work environment, and much more. We invite you to explore exciting and rewarding career opportunities with us. 
  • KAI is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability.


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