Scientist 3 - Clinical Research

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 ( investigator meetings and company sponsored events).
30+ days ago