Job Description

6 Medical Monitor Roles in Princeton Pike, NJ
Length: 6 mos. to start up to 1 year or beyond
Rate: $150
JO#:
Manager: Jeff Anderson (Oncology Division)
JOB DETAILS

SUMMARY: Responsible for implementation, planning, and execution of assigned clinical trial activities; Serves as a Clinical Trial Lead for one or more trials

JOB DESCRIPTION
  • Successfully lead, plan, and execute trial level activities for multiple trials with minimal to moderate level of supervision
  • Provide scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership)
  • Co-Lead 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)
  • Responsibilities include, but are not limited to:
    • 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
      • Evaluation of 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

JOB REQUIREMENTS
  • Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
  • 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 knowledge and skills to support program specific data review, trend identification, data interpretation
  • 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)
  • Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
  • 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; 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
  • 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

Updates/Notes:
  • Title is Medical Monitor but actual job is closer to Sr. Clinical Trial Lead/Sr. Clinical Scientist
  • Any candidates remaining on 30452 have been given to manager for review as well
  • Help support medical monitors and clinical scientists on clinical data review in Oncology and ideally in immuno-oncology
  • Ideal candidate should have data review and issuing of queries experience
  • Local candidates are better but remote would also be accepted (40-hours a week would be best)
  • Specific therapeutic areas is on General Oncology
  • Experience in immuno-oncology agents would make a candidate stronger
  • At least a couple of years of clinical experience for someone with Master's degree and up but for Bachelor's degree at least 5 years.
  • Nursing degree or relevant could be potential candidate
  • Shift would be normal business hours but there is some flexibility
  • Previous medical monitors/clinical scientist would be strong

Equal Opportunity Employer:Eclaro values diversity anddoes not discriminate based onRace, 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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