What we do? SPECTRAFORCE is an award winning global staffing, IT services and consulting company that specializes in providing top talent and solutions for clients throughout North America and India. We pride ourselves on our partnership with our clients, MSP/VMS providers, and our employees, who have enabled us continually be ranked as a Top Supplier in the 75+ different clients we support. Title: Clinical Data Manager Duration: 12 months Location: Summit, NJ, 07901 Descri[ption:  1. Perform clinical data review within the databases (e.g. INFORM, RAVE) cross-checking patient profiles with various data sources, cleaning and querying data, and reviewing subject listings, tables and graphs.  2. Monitoring of safety data including review of serious adverse event reports, generating queries based upon review of adverse event reports, checking concomitant medications, concurrent procedures, verifying co-morbid medical conditions, and reviewing medication and adverse event term coding.  3. Support CRP and CRS in the interpretation of study data as it relates to safety and efficacy.  4. Authoring and review of subject narratives.  5. Support CRP and CRS with key documents for regulatory submission, including authoring and reviewing study protocols/amendments and informed consents.  6. Assist CRS and CRP in the management of clinical studies.  7. Assist CRP and CRS in the review of scientific literature related to assigned clinical programs.  8. Assist CRP and CRS in the preparation of DMC, adjudication, and/or other relevant charters. Assist in the preparation of DMC deliverables and participate in periodic review meetings as appropriate and approved by Clinical management.  9. Provide Clinical Management with regular study updates/status reports.  10. Perform other tasks as assigned by supervisor.  11. Limited or no travel required to support clinical programs.  PRE-REQUISITES: Degree in Life Sciences (e.g. BS in Nursing, Pharmacy or related medical field), Masters degree, PhD or Pharm D. or EQUIVALENT preferred. Previous experience in inflammation and immunology beneficial. Minimum 3 5 years experience in Clinical Research Development or equivalent, preferred. Skills/Knowledge Required:  ? Knowledge of early and late phase clinical program development  ? Proficient at data review and interpretation  ? Basic understanding of global clinical study design and drug development processes  ? Medical/scientific writing skills  ? Knowledge of GCP and ICH Guidelines  ? Detail-oriented, well-organized, able to multi-task  ? Able to exercise sound judgment and escalate issues when necessary  ? Able to assimilate technical information quickly  ? Able to work efficiently, and collaboratively, in a matrix organization  ? Demonstrated ability to work as part of a team  ? High level of interpersonal and communication skills (written and verbal)  ? Proficiency in Microsoft Word, Excel, PowerPoint is a must  ? Proficiency in electronic document repository system a plus Application Process; Application Submission; we will reach out to you over the phone to discuss important aspects of this job opening and upon agreement your profile will be submitted to the client for review. Depending on the size of the selection committee, several interviews are scheduled for each candidate. We will coordinate with candidates to set up interviews with our client. Job offer; After completion of all the interviews, Hiring Manager confers and evaluates applicants based on the interviews, job experience, skills and talent assessments, and all other relevant information (recommendations, e.g.). A top choice should be identified and agreed on. Background checks; After Job offer, background checks would be conducted to review candidates’ criminal record, to verify employment history and eligibility, and to urn credit checks. Drug testing may also be warranted, depending on the nature of the job. Onboarding; Based on the background checks, first day reporting details would be shared with candidate upon the client ‘instructions. Job offer; After completion of all the interviews, Hiring Manager confers and evaluates applicants based on the interviews, job experience, skills and talent assessments, and all other relevant information (recommendations, e.g.). A top choice should be identified and agreed on.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 90.00/hr.