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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Clinical Scientist

Job Description

  • Location: Lawrence Township, NJ
  • Type: Contract
  • Job #78616

Our client, a leading pharmaceutical company, is hiring a Clinical Scientist on a contract basis.

Work Location:
Princeton Pike or Madison, NJ– 100% on site

Summary:
The Early Development Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.

Knowledge/Skills/Education Required:

  • Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).
  • Expectation of 2 years of experience in clinical science, clinical research, or equivalent.
  • Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
  • Ability to understand assigned protocol(s) and their requirements.
  • Knowledge and skills to support program-specific data review and trend identification.
  • Intermediate medical writing skills and medical terminology.
  • Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
  • Basic planning/project management skills (develop short range plans that are realistic and effective).
  • Basic knowledge of disease area, compound, current clinical landscape.
  • Detail-oriented with commitment to quality.
  • Intermediate critical thinking and problem-solving skills.
  • Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
  • Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., patient profiles, report generating tools)
  • Domestic and international travel may be required (approximately 10-20%)

Responsibilities:

  • Responsible for design and execution of assigned clinical trial activities and works closely with clinical team members to execute activities associated with trial conduct.
  • May lead or support trial level activities for one or more trials with the necessary supervision.
  • Collaborate and liaise with external partners (e.g., KOLs).
  • Seek out and enact best practices with instruction.
  • Provide regular and timely updates to manager/management as requested.
  • Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.
  • Conduct literature review.
  • Develop site and CRA training materials and present these at SIVs and Investigator meetings.
  • Review clinical narratives.
  • Collaborate cross-functionally to monitor clinical data for specific trends.
  • Contribute to the development of Data Review Plan in collaboration with Data Management.
  • Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
  • Author/review clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)
  • Submit clinical documents to TMF.
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