Data Management resource II (Clinical)
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location: Northbrook, Illinois
job type: Contract
salary: $60.30 - 70.95 per hour
work hours: 9 to 5
This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
- The Principal DM is primarily responsible for overall program level delivery and vendor oversight for anywhere from 5 - 8 studies of any complexity. The Principal DM may have accountability for specific specialty roles within the DM discipline (e.g., data standards, eCOA, etc.).
- The Principal DM is also responsible for providing leadership and subject matter expertise for key DM related process improvement initiatives globally.
- Monitors key study metrics, to ensure alignment to DS and GD development goals for key drug development projects
- The Principal DM plays an active project management role in team discussions to ensure that all team members and vendor staff are delivering to the commitments on each study.
- Reports to Associate Director/Director Data Management.
- Has several peers within Data Science and Development operations at a similar level
- Sits on study level project teams
- Independent worker, working under loose supervision of Line Manager.
- No direct reports, but oversees the activities of lower level data managers and vendor staff assigned to the individual studies within a drug program.
- Closely collaborates with cross-functional study team members (e.g., GDOL, Study Manager, Clinical Programmer, etc.)
- Interacts with GDOL, GSTATL,GMRL and other core and extended drug development project team members.
- Coaches and mentors lower level data managers and vendor staff as needed for assigned studies and projects.
- BS/BA degree in a biological science, health-related or computer science field. Combination of data management experience and college courses in a related field may be considered.
- Generally, 8 plus years related experience in pharmaceutical, clinical research or health services industry with a minimum of 6 years' experience as Data Manager, with progressive levels of responsibility.
- Demonstrated expertise in DM, inclusive of all activities from program inception to regulatory submission.
- Proven leadership and subject matter expertise for key DM related global process improvement initiatives.
- Prior inspection and major (vendor) audit experience.
- Solid understanding of data standards (i.e., CDISC).
- Strong cross-functional understanding of processes of data management, clinical programming, biostatistics and clinical, with mastery level expertise expected in the DM discipline.
- Strong computer skills, including database management software, reporting tools, medical coding tools, etc.
- Experience with EDC and ePRO systems/devices, including implementation of such systems.
- Excellent verbal and written communication skills.
- Proven ability to work with and influence individuals across multiple disciplines in international environment.
- Proven project management and organizational skills in order to prioritize work for self and others to ensure timelines are met, oversee activities of multiple studies.
- Thorough knowledge of medical terminology.
- In-depth knowledge of the drug development and data management processes.
- Very good knowledge of international regulations for clinical trials (e.g. GCP) and familiar with CDASH/CDISC standards.
- Ability to communicate effectively and maintain effective relationships. Must be able to influence staff in other groups.
- Use of Microsoft Office Suite (Word, Excel).
- SCDM Certified Clinical Data Manager (CCDM) preferred.
skills: MS-WORD, MS-EXCEL, CDISC, CDASH, Clinical Data Management, GCP (Good Clinical Practice)
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.