Data Management resource II (Clinical)

Randstad
 Northbrook, IL

job summary:

As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We are currently partnering with a company known for their leading clinical trials as well as Research & Development. With the goal to constantly develop innovative products, you will feel secure in the fact that you are making a difference. Apply for your dream job now!

location: Northbrook, Illinois

job type: Contract

salary: $60.30 - 70.95 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

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.

qualifications:

Required

  • 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).

Preferred

  • 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.

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