Senior Project Manager – Standards Development

The Senior Project Manager (Senior PM), Standards Development will lead and organize the development of CDISC standards. The Senior PM will have overall operational responsibility for leading one or more projects and be responsible for scoping and initiating, leading teams, tracking and reporting project status and completing deliverables as necessary to complete projects. The Senior PM will also help define business processes, tools and training material to improve the effectiveness of other CDISC standards development teams, and provide other assistance as necessary to facilitate the development of new or enhanced CDISC standards. At a minimum CDISC is looking for creative, self-starters for the Senior PM role that have at least seven years of experience in clinical research, monitoring, data management or clinical project management. Demonstrated experience with CDISC standards and the drug development process is required.

Position Type: Full Time

Reports to: Head of Data Standards

Direct Reports: n/a

Location: home-based in EU or US

Responsibilities of Position:

Standards Development:

  • Lead new projects consistent with CDISC goals, policies and procedures, including definition of project scope, plans, timelines, dependencies, risks, goals and deliverables
  • Organize and lead project/team meetings with well-defined agendas and minutes
  • Monitor project progress and ensure timely completion of deliverables
  • Prepare periodic status reports, including accounting of time spent
  • Ensure use of CDISC wiki and JIRA by team members
  • Document and track action items with assigned responsibilities to meet planned milestones
  • Resolve or escalate issues to management when they arise
  • Prepare and present projects at internal and external meetings
  • Maintain and develop project plans
  • Development of standards development process documentation and associated checklists
  • Travel as necessary to meet with volunteers, team members or conduct meetings
  • Identify best practices, lessons learned, areas for potential process improvement and recommend solutions
  • Adhere to all CDISC policies and procedures, including the Code of Ethics and the Intellectual Property Policy

Qualifications:

  • Bachelor’s Degree in a relevant field such as Health Sciences, Life Sciences, Data Management, Information Technology or Biostatistics or equivalent experience (Required)
  • At least five years of supervisory or project management experience, which may be partially met by training or certification (Required)
  • At least seven years of experience in clinical research, monitoring, data management or clinical project management (Required)
  • Excellent organizational, problem-solving, listening, oral and written communication skills, including familiarity with health or life sciences information and understanding of the clinical development process (Required)
  • Experience coordinating volunteers (Required)

Leadership Skills:

  • Understands and supports the CDISC mission and shared values
  • Creative self-starter and life-long learner open to new ideas and able to work with minimal supervision in a challenging, fast-paced technical environment
  • Team player that values cooperation and collaboration
  • Demonstrated leadership skills and ability to manage, motivate and integrate a team to achieve their mission and objectives, develop consensus decisions and celebrate achievements
  • Ability to work well with volunteers and make certain that volunteer’s time is well spent by ensuring that meetings are well organized, goal oriented and enjoyable
  • Ability to understand the big picture in projects comprised of many complex, interrelated players and parts
  • Excellent facilitation skills during F2F and teleconference meetings
  • Demonstrated negotiation and interpersonal skills, ability to encourage open discussion, conflict resolution, and consensus building

Other skills and capabilities:

  • Language: Excellent verbal and written English communication skills (required)
  • Ability to work in a virtual environment remotely located from supervisor
  • Exposure to CDISC standards and standards specifications
  • Facility with Atlassian Wiki and Jira tools
  • Clinical trials data standards experience (preferred)
  • Knowledge or experience with standard terminology systems such as MedDRA, SNOMED, ICD-9/10, LOINC, NCI-EVS, CDISC terminology, etc.

Physical work component:

  • Sedentary: lifting no more than 10 pounds at a time and occasionally lifting or carrying articles like docket files, ledgers, and small tools.

Travel requirement:

  • Travel for this position is expected to be 10% or less.

For applicants

  • Please send your resume/CV, cover letter and salary expectations to jobs@cdisc.org.
  • Applications without a complete cover letter including salary expectations cannot be considered.