Clinical Research Scientist - LanceSoft Inc
TITUSVILLE, NJ 08560
About the Job
Title: Senior Scientist Clinical Research
Location: Titusville NJ 08560
Duration: 4 months
Pay Range: $55.00/HR - $61.00/HR
Notes from HM
- This role will be REMOTE, but must reside in Eastern Time Zone (Must be able to be ONSITE 1 day every 2 weeks in Titusville)
- This role would be a Clinical Scientist
- Must have at least a Bachelor's Degree (a Master's degree or PhD would be very helpful in a Life Science category)
- Must have Pharma and/or Clinical experience
- Going to be a Clinical Scientist (specifically in Neurosciences)
- Will be reviewing data
- Must have Clinical Development experience
- Experience with Translation & Implementation of Scientific Concepts (non-medical)
- Will be planning, executing, and reporting
- No lab experience is required
- Have Data Visualization experience (Tableau)
- Assisting with Study Close Outs
- Will participate in Data Monitoring
- Must have at least 3-5 years of experience
Description:
Senior Scientist Clinical Research
Location: Titusville NJ 08560
Duration: 4 months
Pay Range: $55.00/HR - $61.00/HR
Notes from HM
- This role will be REMOTE, but must reside in Eastern Time Zone (Must be able to be ONSITE 1 day every 2 weeks in Titusville)
- This role would be a Clinical Scientist
- Must have at least a Bachelor's Degree (a Master's degree or PhD would be very helpful in a Life Science category)
- Must have Pharma and/or Clinical experience
- Going to be a Clinical Scientist (specifically in Neurosciences)
- Will be reviewing data
- Must have Clinical Development experience
- Experience with Translation & Implementation of Scientific Concepts (non-medical)
- Will be planning, executing, and reporting
- No lab experience is required
- Have Data Visualization experience (Tableau)
- Assisting with Study Close Outs
- Will participate in Data Monitoring
- Must have at least 3-5 years of experience
Description:
Senior Scientist Clinical Research
- Responsible for the translation and implementation of (non-medical) scientific concepts into the study design and/or program across planning, execution, and reporting, including integration of biomarkers, digital technologies, data science initiatives, and select vendors
- Program/Trial Planning, Execution and Reporting
- Responsible for leading the translation of scientific concepts into program and study design
- Responsible for identifying and implementing (non-medical) scientific aspects of the program and/or study at planning, execution and reporting, including (but not limited to) integration of Biomarkers and Data Science/Digital Health initiatives into studies.
- Oversees the assessment, selection and operational implementation for biomarkers, digital and other endpoints (scales), imaging
- Accountable for shaping and implementing compound and program DEI strategy together with Clinical Leader
- Provides expert input in clinical development plans
- Contributes to the preparation of PED, study protocols and training materials for clinical studies.
- Prepares for and participates in Protocol review Committee (PRC) and First in Human (FIH) Committee meetings
- Reviews medical and scientific literature
- Along with SRP or Clinical Leader and global development partners, responsible for oversight and high-quality implementation and closure of the study, ensuring data integrity
- Responsible for the TA review and sign off on various operational plans
- Responsible for scientific input into HA and EC responses.
- In concert with operational staff, acts as a liaison between the company and clinical investigators for overarching scientific guidance and other potential non-medical aspects
- Works closely with Data Sciences, Data Management, Statistics, Programming, JJIT and others to ensure data are received in the manner needed to support trial outcomes
- Responsible for the review of the data to ensure quality and to identify data quality trends.
- Sets up and leads Adjudication Activities
- Leads data visualization (DV) meetings and ensures decisions are documented and communicated internally and externally
- Owns contracting with clinical consultants, IDMC members and KOLs, including payment oversight.
- Participates in vendor oversight focusing on the integration of data and technology in clinical trials
- Contributes to completion of clinical study reports
- Contributes to the interpretation, reporting and preparation of oral and written results of product research in concert with senior clinical personal, in preparation for health authority submissions.
- Partners with Regulatory Affairs in developing regulatory strategy and determining requirement for health authority reporting or corrective actions on trial/program level
- May help explore and evaluate new assets (Client) and/or products to support compound value
- Oversees the set-up of medical review tools to meet medical review plan requirements
- Participates in Data Review Meetings
- Qualified CS may perform aspects of medical review under supervision of CL or SRP
- Safety monitoring summaries linked to quarterly medical reviews and/or monthly medical reviews may be delegated to qualified CS
- Assists in organizing content for IDMC presentation
- Contributes in all areas where scientific data will be generated and shared with the patients and/or the scientific community
- May be asked to assess medical publications emerging from the Team and its affiliates
- May act, in concert with senior clinical personnel, as the company spokesperson regarding publication of clinical research findings. This may include presenting research results at internal/external meetings (i.e. investigator meetings and company sponsored events).
- PhD in relevant field (e.g. Neuroscience, Biomedical Sciences, Biology; chemistry: pharmacy) , PharmD or MD degree from an accredited institution with 1-2 yrs work experience; or Masters in relevant field with 2-4 yrs work experience
Source : LanceSoft Inc