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Reference # : 21-00239 Title : Clinical Scientist with Global Drug Development
Location : Lawrence Township, NJ
Position Type : Contract
Experience Level : Start Date : 01/25/2021  

Project Description:
  • Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more trials.
  • Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision.
  • Provides scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership).
  • Co-Leads study team meetings in partnership with GDO protocol manager; and collaborate with cross functional study team members.
  • May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning).
  • Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members.
  • Plan and lead the implementation all study startup/conduct/close-out activities as applicable.
  • Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead).
  • Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing).
  • Site-facing activities such as training and serving as primary contact for clinical questions.
  • Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team.
  • Clinical data trend identification; provide trends and escalate questions to Medical Monitor.
  • Develop clinical narrative plan; review clinical narratives.
  • Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
  • Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities.
  • Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses).
  • Collaborate and serve as primary liaison between external partners for scientific advice.

Required Skills:
  • Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred).
  • 5+ years of experience in clinical science, clinical research, or equivalent.
  • Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
  • Proficient knowledge and skills to support program specific data review, trend identification, data interpretation.
  • Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
  • Excellent verbal, written, communication and interpersonal skills.
  • Must be able to effectively communicate and collaborate across functions and job levels.
  • Ability to assimilate technical information quickly.
  • Routinely takes initiative.
  • Detail-oriented.
  • Strong sense of teamwork; ability to lead team activities.
  • Proficient in Medical Terminology and medical writing skills.
  • Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile).
  • Proficient critical thinking, problem solving, decision making skills.
  • Understanding of functional and cross-functional relationships.
  • Commitment to Quality.
  • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
  • Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals).
  • Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools.
  • Domestic and International travel may be required.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: