Director, CDISC Service Group

Location
Rockville, Maryland
Salary
Competitive
Posted
Oct 05, 2019
Closes
Nov 04, 2019
Ref
2259
Function
Executive, Director
Industry
Science
Hours
Full Time
The Emmes Corporation, established in 1977, is a woman-owned, private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

Emmes' CDISC Service Group is a corporate-wide resource group with dedicated CDISC Research Unit Managers, CDISC Data Specialists, and CDISC SAS Programmers. The CDISC Service Group Director is responsible for overall oversight and management of the Service Group and will report to Emmes' Chief Operating Officer. Preferred candidates will have expert knowledge of CDISC standards, past management experience, and extensive involvement in clinical trial data submissions to the FDA.

Responsibilities
  • Service Group Supervision, Management, and Oversight
    • Direct supervision and performance review of staff including assignment and utilization
    • Organization of the Service Group, including development and designation of managers to projects, groups of projects, or Research Units as necessary
    • Track budgets for CDISC activities
    • Training and development of staff including management of the Group's Professional Development budget
    • Lead regular Service Group meetings including agenda development
    • Ensure quality of CDISC submissions to clients and/or regulators
  • Project consultation and management
    • Strategic planning for CDISC efforts and submissions based on client expectations, product development plans, internal resources, current standards, and agencies involved
    • Determine timelines, resources, and expertise necessary to generate CDISC data structures and supporting materials
    • Communicate with project management regarding timelines, changes to timelines, and any organizational or technical challenges as they arise
  • Direct technical support including:
    • Protocol and CRF review
    • Development or review of DEFINE.XML
    • Review of SDTM mapping
    • Review of ADaM mapping
    • Development or review of Reviewers Guides
    • Development or review of Study Data Standardization Plans
    • Authorization of the data components of regulatory submissions
    • Direct client engagement regarding mapping and submission expectations and challenges
  • Management of Corporate CDISC standards and procedures
    • Oversee review and update of internal SDTM Implementation Guides as necessary including determination of need for new domain, therapeutic-area or other specialized Implementation Guides to ensure quality project support
    • Oversee review and update of internal Controlled Terminology
    • Oversee review and update of internal CDISC Standard Operating Procedures
  • CDISC Business Development activities
    • Engage directly with clients, or through project staff, regarding CDISC-only client support
    • Maintain stock CDISC proposal language and customize as necessary for new business proposals
    • Provide budget (hours) estimates for new business proposals
    • Maintain knowledge of competing CDISC service offerings in the marketplace.
  • Maintenance of CDISC Expertise and Corporate profile with CDISC
    • Ensure Service Group is up to date with latest CDISC standards and regulatory requirements/expectations
    • Ensure Emmes remains engaged with CDISC including conference presentation, participation in committees or panels, contribution to new and evolving standards, etc
    • Provide internal training to non-CDISC Service Group staff

Experience
  • Bachelor's degree and 15 years of relevant experience in Statistics, Statistical Programming, Data Management and/or CDISC Services. Masters or PhD in a scientific/technical discipline preferred along with 10 or more years of relevant experience in Statistics, Statistical Programming, Data Management and/or CDISC Services
  • Possess expert level knowledge of CDISC Standards, particularly theory & application of SDTM Standards
  • Possess expert level knowledge of U.S. FDA and International regulations, guidance documents, and regulatory process pertaining to data submission standards
  • Prior demonstrated work history developing and implementing CDISC Implementation Guides
  • Possesses advanced analytical skills with the ability to interpret data/information and its practical application
  • Prior management/supervisory experience required
  • Strategic thinking, leadership skills, assertiveness, strong technical background, good business judgment, integrity, and excellent negotiation and project management skills as evidenced by past performance on product development teams
  • Excellent organizational, planning, analytical, and problem-solving skills. Attention to detail required
  • Ability to build and maintain positive relationships with management, peers, and subordinates
  • Excellent verbal and written presentation and communication skills are necessary. Highly motivated, results driven with unyielding predisposition to detail, accuracy and clarity; performs duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA
  • Consistently exercises sound judgement and effectively prioritizes competing tasks in a fast-paced and dynamic environment
  • Possess high degree of initiative and the ability to work collaboratively across teams to describe service group offerings and align management with programmatic needs
  • Sound knowledge in MS Office (Word, Excel, and PowerPoint) and PDF rendering tools


Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs

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The EMMES Corporation is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.