Scientist 3 - Clinical Research - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
Responsibilities and Requirements:
- 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 personnel, 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 and Safety management.
- Oversees the set-up of medical review tools to meet medical review plan requirements.
- Participates in Data Review Meetings.zQualified 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 and Publication.
- Contributes to 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).
Source : Katalyst Healthcares & Life Sciences
