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Clinical Operations - Running/Operations of Clinical Trials Temp - Project Associate II (data standards) -REMOTE (HYBRID in Basking Ridge, NJ preferred) Basking Ridge , NJ
ID: 23381

Job Title: Temp - Project Associate II

Location: Hybrid – Basking Ridge, NJ

Contract: 6 months for starters with potential to extend

  • Develop operational global clinical data standards across different Therapeutic Areas following CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology
  • Develop and Maintain SQL queries to extract, manipulate, and Analyze Clinical data
  • Create and Optimize J-review programs for clinical data review and reporting
  • Collaborate with multiple line functions to understand data requirements and deliver solutions.
  • Work on Processing Change Requests that require updates to the standards at study level and global level
  • Ensure data integrity and accuracy in all SQL and J-Review Outputs
  • Participate and leading in relevant governance team meetings and provide standards input as assigned and document meeting minutes
  • Works with assigned clinical project teams to use defined standards.
  • Responsible for at least one catalog type e.g. eCRF, Edit checks, CCGs ,Global ALS, DTS, Listings /Report Specifications, etc.)
  • Assist in Library Maintenance across different Therapeutic Areas, co-lead/lead standards governance team meetings.
  • May update functional SOPs, Working Procedures and other internal documents
  • Identify and propose process improvements from CDISC/SDTM/CDASH standards perspective
  • Provide guidance to study teams on creating eCRFs to support clinical database set up.

Compensation Details:

  • Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
  • The Pay Range for this position is $40.00 - $50.00 per hour, can vary depending on employment status.
  • Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.

Fill out the form below to get in touch with our business development team, or call us at  (781) 328-1132.

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The Company is an equal opportunity employer and makes employment decisions on the basis of merit. The Company prohibits unlawful discrimination on the basis of race, color, national origin, ancestry, religion, creed, age, sex, sexual orientation, gender identity, pregnancy, marital status, physical or mental disability, medical condition or any other consideration made unlawful by federal, state or local laws. The Company will also provide reasonable accommodation to the known physical or mental disability of an otherwise qualified employee or applicant. Should you need any such accommodation, please contact the Company for further information. The Company is dedicated to ensuring that all decisions regarding personnel are in accordance with all applicable laws. I certify that all statements made in this application are true to the best of my knowledge. I understand that all falsification or misleading information given in my application may result in the termination of my employment with Orbis Clinical and its subsidiaries. Furthermore, I understand that my professional conduct and clinical performance is directly related to my ability to be placed on assignments for Orbis Clinical and that I will adhere to all regulations and guidelines of Orbis Clinical. I authorization Orbis Clinical to verify the information I have provided, to contact references, and to conduct criminal, education and personal background checks concerning my qualifications, and past employment record. I understand that nothing contained in this application is intended to create an employment contract, either verbal or written, with Orbis Clinical or its clients. Furthermore, I understand that my employment, it is “at will” and Orbis Clinical or I may terminate my employment at any time with or without notice and with or without case. I acknowledge that I will be legally obligated by the terms of this document by typing my name, which will constitute my signature, or manually signing, in the provided space and electronically transmitting this document to Orbis Clinical. I agree that Orbis Clinical and I may use electronic means to conduct this transaction and that this document shall be governed and construed by the laws of the State of Massachusetts.