Sr. CDM

Executes Data Management (DM) activities per set timelines with quality and consistency for a given product or multiple products

 The lead FSP Data Management point of contact for the Sponsor Data Management Operations Lead
regarding all day to day activity on a study with key responsibilities for study set up, conduct and
close-out tasks, as well as overseeing and coordinating tasks delegated to the supportive DM study
team members.
 Works closely with the corresponding Sponsor Data Management Operations Lead (DMOL) to ensure
a seamless delivery of Data Management deliverables including holding regular status meetings with
DMOL and other SMT team members as appropriate’
 Ensures study/ team deliverables are executed to expected quality and timelines, provides technical
oversight as needed, and mentors/develops Clinical Data Management teams and other staff under
the guidance of Manager / Sr. Manager, Data Management or designee.
 Fulfils his/her job responsibilities in accordance with Good Clinical Practices (GCPs), ICON Standard
Operating Procedures (SOPs), Working Procedures (WPs), Study Specific Procedures (SSPs),
Sponsor SOPs/WPs as appropriate, International Committee on Harmonization (ICH) Guidelines and
applicable law and regulations.

 Recognize, exemplify and adhere to ICON's values which centre on our commitment to People,
Clients and Performance.
 As a member of staff, the employee is expected to recognize the importance of and create a culture of
process improvement with a focus on streamlining our processes adding value to our business and
meeting client needs.
 Read, ensure understanding and adhere to all assigned ICON and/or Sponsor SOPs and working
procedures (as appropriate).
 Ensure all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines
and all applicable laws and regulations.
 Complete all assigned trainings and courses in the ICON Training Management system (iLearn) (and /
or sponsor system, as appropriate); ensuring all mandatory courses are completed before the
designated date.
 Read, ensure understanding and adhere to the study protocol, contract and scope of work for all tasks
during set up, maintenance and close out of the study.
 Record all billable and non-billable time in the appropriate timesheet management system (as
required).
 Lead the development of specifications, implementation and testing for the CRF.
 Lead the development of specifications, implementation and testing for the edit checks and data
review listings.
 Lead the development of all other relevant Data Management specifications as required per process
 Ensure the effective implementation of standard metrics and ongoing status reporting on the study.
 Manage and provide leadership to local Data Management teams to ensure project objectives are met
within budget and agreed timelines.
 Adhere to the Client/ICON SOPs, the Data Management Plan, Working Procedures and Study
Specific procedures in the implementation of tasks on the study.
 Support project management of activities in all locations, liaise with project/study teams, and escalate
issues to local management and global study teams in a timely manner.
 Identify and clearly articulate DM risks and mitigation efforts, proactively applying contingencies
wherever and whenever needed. Can identify the appropriate parties for escalation and can judge
when to escalate further if needed.
 Provide resource projection and/or changes on an ongoing basis to Management as appropriate.
 Support and Mentor direct/indirect reports and extend technical expertise on an ongoing basis.
 Identify training needs and organize trainings as appropriate in coordination with ICON University
and/or Sponsor.

Basic qualifications

• Doctorate degree OR
• Master’s degree & 3 years of clinical experience OR
• Bachelor’s degree & 5 years of clinical experience OR
• Associate’s degree & 10 years of clinical experience OR
• High school diploma / GED & 12 years of clinical experience

Preferred Qualifications

• Bachelors degree or equivalent in life science, computer science, business administration or related discipline
• 6+ years work experience in data management in the Pharmaceutical or Biotech arena
• 3+ years project management and planning experience
• Experience in oversight of outside vendors (CROs, central labs, imaging vendors, etc.)