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Clinical Scientist
2 months ago
Are you looking for your the next step in your career? Kelly FSP is seeking a Clinical Scientist with a background in Neurology to join us to partner with one of our pharmaceutical clients in Titusville, NJ. This position is a hybrid model requiring a minimum of one day on site weekly.
Clinical Scientist
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
Job Responsibilities
- Program/Trial Planning, Execution & Reporting
- Responsible for leading the translation of scientific concepts into program & study design
- Responsible for identifying and implementing (non-medical) scientific aspects of the program and/or study at planning, execution & 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.
- Additional Clinical Research Responsibilities
- 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 (BD) and/or products to support compound value
- Safety Management
- 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
- External Communication & Publication
- 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)
Specific Skills, Capabilities, and Knowledge Required
- PG30: PhD in a relevant field (e.g. Neuroscience, Biomedical Sciences, Biology; chemistry: pharmacy), PharmD or MD degree from an accredited institution) with 2-4 yrs work experience; or Masters with 4-8 yrs work experience
- Experience in clinical research/drug development that has exposed the individual to the rigors of human trial conduct with pharmaceuticals, devices, basic clinical practice with the precepts of Good Clinical Practice
- Energy and enthusiasm are essential.
- Experience in Neurology, Psychiatry or Neuroscience is strongly preferred.
- Clinical research operational knowledge, strong project planning/management and excellent communication skills are required.
- Ability to operate with limited day to day supervision is required.
- Independent decision-making and analytical skills are required.
- Successful work experience in a (virtual) matrix team environment with cross functional teams is required.
- Travel up to 20% of time both domestic and international is required.
