General Information

Location: Hamilton, NJ

Organization: Medavante-Prophase, Inc

Job Type: Full Time - Regular

Description and Requirements

SUMMARY OF POSITION: The Director Clinical Data Management (CDM) leading the company’s data management function and will be accountable for three main functions within the Clinical Data Management department: Data Management (including management of internally and externally generated data as well as clinical data validation services), Data Programming, and Data Coordination. This role will be part of the company’s senior leadership team and will align and build the Clinical Data Management’s capabilities to the company’s strategic vision and business goals.

EDUCATION REQUIREMENTS:

·         Bachelor’s degree required; advanced degree preferred.

QUALIFICATIONS/EXPERIENCE:

  • 10+ years of progressive experience in clinical research, academic biomedical or mental health research, or in the pharmaceutical services industry or in a related industry required
  • 5+ years in a pharmaceutical, biotechnology, CRO, or related environment required
  • Thorough knowledge of the pharmaceutical industry and terminology, understand the drug development process and the role of sponsors, sites, CROs, and other stakeholders in the process required
  • Proven leadership capabilities, with a minimum of 5 years of direct management of employees, including managing of managers.
  • Experience with eCOA data, understanding of SAS dataset structure, and electronic reporting applications in Clinical trials strongly recommended.
  • Proven track record in building internal capability, growing a function and its employees
  • Working knowledge of GCP, ICH, 21 CFR part 11, or other international regulations required
  • Working knowledge of industry data standards such as CDISC SDTM, CDASH, or HL7 required
  • Excellent written and oral communication skills, organization, interpersonal skills and ability to work with people from a variety of backgrounds and at all levels of the organization

ESSENTIAL DUTIES/RESPONSIBILITIES:  Duties include, but are not limited to, the following:

  • Maintenance of the capabilities in clinical data management and clinical data programming services.
  • Oversee the execution of clinical data management and SAS programming.
  • Manage the Clinical Data Management department, ensuring the development and readiness of personnel to deliver on existing programs while also being forward-looking and innovative.
  • Accountable for three main functions within the department: Data Management (including management of internally and externally generated data as well as clinical data validation services), Data Programming, and Data Coordination.
  • Oversee the timely execution of data management and SAS programming and data coordination services (internal and external)
  • Provide input in the development of key control documents (e.g., data management plans and related documents)
  • Build as well as provide guidance to clinical data programmers as well as provide input into the strategic direction of the Clinical Data Management group to align with the overall business strategy and service offerings.
  • Lead systematic professional development and provide strong support for direct reports and other members of the Clinical Data Management department
  • Continual engagement of the larger organization to assess needs and build/maintain a capability for data management and SAS programming and collaborate with senior management team/other departments to develop and implement programs and strategies, as needed
  • Maintain awareness of industry standards, regulatory requirements and SOPs on both clinical data management and clinical data programming

SUPERVISORY RESPONSIBILITIES: The position will require the individual to be responsible for the management, direction, coordination, performance, and evaluation of an assigned team and staff.

TRAVEL REQUIREMENTS: Ability to travel domestic and internationally, approximately 10% of the time, including overnight stays as necessary, consistent with project needs and office location.