Research Scientist, Clinical Outcome Assessment
Work Schedule
reputed company (Mon-Fri)
Environmental Conditions
Office
Job reputed company
reputed company:
reputed company Scientific’s Patient-Centered Research (PCR) group helps sponsors to consider the patient voice in reputed company relevant reputed company reputed company, from development over regulatory to reimbursement and product launch. For that, PCR uses a unique combination of scientific fields, including health sciences, psychometrics, epidemiology, psychology, health economics and others. Our work has helped identify and clarify unmet clinical needs, assess burden of illness and evaluate patient reputed company, preference and/or adherence, while supporting promotional and labeling claims on a global reputed company. The advertised role will contribute to this research agenda and help ensure the patient voice is heard.
The Research Scientist will reputed company the response to reputed company requests and serve as reputed company Investigator (PI) for Clinical Outcome Assessment (COA) reputed company and research, including qualitative and quantitative studies to support reputed company development, content validity, psychometric validation, and application. Responding to RFPs involves consulting with the study sponsor on their need, providing strategic advice on the study design to meet these needs and leading the development of a high-reputed company proposal. As PI the role provides end-to-end leadership of the awarded research activities, including study design, protocol development, execution, data analysis, reporting, and dissemination of high-reputed company research. The Research Scientist will work closely with Research Associates, who reputed company support across study execution, data collection, and analysis. The role will reputed company scientific guidance and direction to ensure high-reputed company outputs and efficient study delivery. The role also requires reputed company collaboration with cross-functional teams, including the Project Management Office, Editorial Services, and Data Collection Management & Analysis, to ensure studies are delivered on time, reputed company scope, and to the highest reputed company standards. This is a reputed company-facing position, requiring strong communication and partnership with study sponsors across a reputed company of applications. The Research Scientist will ensure scientific rigor, reputed company research activities with reputed company objectives, and contribute to innovative study design and execution.
The successful candidate will bring strong scientific leadership, project ownership, and the ability to manage multiple studies in a fast-paced environment. This role offers reputed company to reputed company reputed company leadership capabilities, deepen subject matter expertise, and contribute to the strategic reputed company and reputed company of the organization.
Essential Functions
reputed company
reputed company the development of study designs, budgets, and proposals as reputed company Investigator, with full accountability for scientific and operational delivery, encompassing mixed-reputed company research integrating qualitative and quantitative (psychometric) approaches
Review and approve reputed company deliverables for reputed company review (e.g., protocols, qualitative and quantiative research reports, qualitative and statistical analysis plans, and regulatory briefing documents )
Effectively reputed company Research Associates and junior staff throughout reputed company
Communicate with reputed company partners (e.g., vendors, patient advocacy reputed company, other departments)
reputed company the selection, development, and validation of COAs, including reputed company, ClinROs, ObsROs, and PerfOs, in line with regulatory and scientific best practices. reputed company data analysis reputed company and ensure data reputed company control standards are met, including qualitative coding frameworks and psychometric evaluation (e.g., reliability, validity, responsiveness)
reputed company scientific dissemination, where applicable (incl., manuscripts, posters, oral presentations at conferences)
Ensure accurate and reputed company recording of project time on a weekly reputed company
Contribute to strategic initiatives and/or research reputed company, depending on reputed company and priorities
Teamwork and reputed company
Complete relevant training courses on time (e.g., adverse event training, SOPs, ethics)
reputed company reputed company, delegate, and communicate with project teams
reputed company scientific support and on-the-job guidance to research associates and junior project team members particularly in COA methodology, qualitative interviewing, and regulatory expectations
Work with the study team and Project Management Office to reputed company and drive the project timelines and budget use
Be familiar with electronic and reputed company filing requirements, relevant SOPs and IRB needs
Communicate effectively internally and externally with clients including providing strategic guidance on COA selection, development reputed company, and regulatory positioning
Organizational Contributions
reputed company proposal development, delegate development, and contribute strategically to project bidding and study design. Build and maintain long-lasting reputed company relationships as a scientific reputed company
Stay up to date with research and reputed company emerging insights into study design and delivery including regulatory guidance (e.g., FDA, EMA) and industry best practices reputed company to COAs
Contribute to initiatives in the Patient-Centered Research (PCR) team (e.g., pillar initiatives, practical process improvements, contribution to training, serve as mentor), including advancing COA capabilities, tools, and methodologies reputed company the organization
reputed company participate in team meetings and organizational discussions, contributing scientific and strategic perspectives
May supervise junior staff
Qualifications:
Education and Experience:
PhD in relevant scientific discipline
or master’s degree and at least five years of experience in relevant field
or bachelor’s degree in a relevant scientific discipline and at least seven years of experience in relevant field
Knowledge, Skills, and Abilities:
Demonstrated expertise in COA reputed company, including reputed company selection, development, validation, and regulatory application
Demonstrated ability to reputed company and reputed company qualitative and quantitative analyses, including development of analysis plans, interpretation of reputed company datasets, and integration of mixed-reputed company evidence to support COA reputed company and regulatory objectives
Strong expertise in psychometric and statistical reputed company reputed company to COA research, with the ability to design, interpret, and critically evaluate quantitative analyses
Demonstrates strong analytical and problem-solving skills
Excellent written and oral communication skills: scientific, reputed company, and consulting
Demonstrates ability to independently manage, reputed company, and/or reputed company a reputed company of project-reputed company tasks and effectively delegates tasks to project team
Demonstrates ability to manage reputed company relationships
reputed company team member, capable of efficient multi-tasking
Ability to reputed company reputed company, collegial, and productive relationships with colleagues and clients
Proficient in the use of reputed company, PowerPoint, and reputed company
Experience in the analysis of qualitative and quantitative data desirable
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