BioTelemetry Research- Director, Data Management

US-MD-Rockville
5 months ago
Job ID
2017-2599
# Positions
1
Company
Cardiocore Biotelemetry Research

Overview

Director, Data Management

Rockville, MD or Rochester, NY

 

The Director, Data Management, has responsibility for oversight of the life cycle of data management activities and deliverables associated with clinical research studies.  This role manages a team of data managers and data technicians responsible for the organization’s data management functions from study start-up through database lock and final data delivery.  The Director, Data Management interacts with Cardiocore management, Project Management, Medical Operations, Regulatory Compliance, and Customer Support, as well as other groups within the Clinical Research Systems organization.  In this role, successful collaboration and interaction with external customers and partners is essential.   This multidisciplinary position requires broad data, project management and business skills, as well as the ability to direct multiple, diverse activities and initiatives.

 

Responsibilities

 

  • Overseeing data management operations and personnel, including management and prioritization of activities and projects
  • Staffing and ensuring the team has the tools and training required
  • Providing clear expectations of responsibilities, deliverables and due dates to team members
  • Actively incorporating Good Clinical Data Management (GCDM) practices and data standards (e.g., CDISC CDASH, SDTM) into departmental processes and procedures
  • Identifying and implementing opportunities to improve existing processes for key team functions
  • Establishing metrics in support of ensuring data integrity
  • Ensuring deliverables and projects are completed on time, and that finished products are of high quality and meet requirements
  • Representing the data management function in sales presentations to clients and client meetings
  • Collaborating with other members of the Clinical Research Systems team in the design, documentation, testing and implementation of clinical data management systems and procedures
  • Recommending enhancements and technical innovation where needed to support data integrity initiatives and activities
  • Communicating status on an ongoing basis
  • Working closely with the Regulatory Compliance organization to ensure that processes are properly and efficiently codified in corporate Quality System Procedures
  • Other duties as assigned
  • The physical demands are representative of those an employee encounters while performing the essential functions of this job.

Qualifications

 

Education:  

  • Bachelor's Degree in a life science, business or technical discipline
  • Master’s Degree, or equivalent work experience

 

Experience:

  • Ten or more years of relevant professional experience, including direct staff management
  • Minimum of eight years of experience in Data Management roles
  • Significant data analysis experience, particularly in definition and specification of data structures, database design concepts and data output options
  • Demonstrable experience in effective verbal and written communications and interaction with internal and external customers at all levels
  • Experience with development, deployment and support of data management processes and procedures in a regulated business environment
  • Experience in a contract research organization, pharmaceutical, or biotechnology environment preferred.

 

Skills:

  • Ability and willingness to be “hands on” for initial assessment of gaps and areas for improvement and as needed
  • Superior verbal and written communications and presentation skills for multiple audiences including customers, data management team, and executive/senior management teams
  • Ability to build consensus across diverse groups and work in cross-functional teams
  • Detail-orientation to ensure that issues are resolved to customer satisfaction
  • Agile, creative problem-solving abilities to provide direction to sustain team in investigating issues
  • A “can do, must do” problem solving attitude
  • Facilitation, mediation and negotiation
  • Leadership in helping staff to solve problems collaboratively without making decisions for them, and in holding team and individuals mutually accountable for results
  • Ability to balance the relationships between customer, operational and budgetary concerns
  • Ability to understand and clearly communicate to other members of the organization data specifications, principles and general methods of data management
  • Proficient in data analysis, data file structures, database design concepts and practices
  • Proficient in use of computer systems and tools, including Microsoft Office applications such as Project, Visio, Excel, Word, PowerPoint
  • Familiarity with all phases of the clinical trial life cycle and Good Clinical Data Management (GCDM) practices
  • Familiarity with clinical data management systems and tools, such as SAS (Statistical Analysis System)
  • Familiarity with applicable regulatory guidance and rules, e.g., 21 CFR Part 11, FDA guidance, GCP, ICH E14

 

The company is an equal opportunity employer.

 *CB

 

Company

Cardiocore Biotelemetry Research

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