Research Scientist – Patient-Centered Outcomes & In-Trial Research

Join Us as a Research Scientist- Make an Impact at the Forefront of Innovation

Team: In-trial research team within the Patient-Centered Research group

Location: North America or Europe

The ITR Research Scientist is the independent Principal Investigator of projects responsible for overseeing all aspects of project delivery; delegates project management tasks to more junior scientific staff. Takes scientific responsibility for project completion; responsible for strategic consultation and for use of best methods to address research needs. Able to oversee and participate in a large project portfolio. Innovates scientifically and produces output of high scientific quality. Assumes significant responsibilities for sales targets and client development.

Essential Duties and Responsibilities (other duties may be assigned):

Standard (Mon-Fri)

Office

Evidera's Patient-Centered Research (PCR) group combines a unique portfolio of scientific disciplines, including health sciences, psychometrics, epidemiology, psychology, and many other social sciences. Our PCR staff conduct a variety of studies using quantitative and qualitative approaches to develop clinical outcomes assessments, evaluate patient preferences and utilities, execute various implementation science studies, conduct Delphi panels and do secondary data analysis using advanced statistical techniques.

Within the PCR group, the ITR team conduct qualitative (interviews) studies and/or surveys in the context of a clinical trial to obtain feedback from clinical trial participants (patient, caregiver, investigator or study staff) on various topics i.e., understanding patients' experience with their condition, its impacts on their lives, exploring treatment benefit, describing trial participant experiences and identifying aspects of burden from their participation. ITR can be implemented using an embedded design (e.g., ITR is defined as clinical trial activity in the clinical trial study protocol and ICF) or associated design (ITR is covered under separate protocol, separate ICF, and IRB/EC approval, with separate site recruitment and contracting). ITR can be conducted at any trial phase and at any time in the trial (screening, mid-trial, exit). Over the past few years, there has been a growing interest in ITR studies by regulators to support relevance and interpretation of trial outcomes, meaningful change and/or meaningful treatment benefit.

• Applies in-depth knowledge of scientific methods, mainly qualitative but also quantitative.
• Presents scientific work in peer-reviewed journals and at professional meetings.
• Provides scientific leadership to team members.
• Produces deliverables of high scientific quality.
• Advises and implements best methods and scientific innovation in project plans and design.
• Highly productive in terms of number and volume of scientific projects responsible for, involved with, and consulting on.
• Knowledge of regulatory requirements and guidelines.
• Scientific contributions may include:
• Development and delivery of scientific studies and results directly to clients.
• Assisting colleagues to optimize study design and implementation when scientist has specific areas of expertise.
• Non-project related publications, presentations, workshops, advisory boards, participation in FDA meetings, etc.

• Develops and maintains client relationships.
• Understands pharmaceutical industry/FDA structure.
• Identifies scientific methods/plans that help clients meet their goals as well as those that will not help clients meet their goals.
• Provides scientifically rigorous deliverables that best help clients meet their objectives.
• Helps clients prepare for regulatory meetings and attend regulatory meetings with clients as requested.

• Brings in proposal leads.
• Writes proposals and managing proposal writing process.
• Closes sales.
• Meets annual target utilization rate of 60%, unless otherwise specified.

• Manages internal timelines to ensure that deliverables meet external client timelines.
• Manages internal budget/staff hours per project not to exceed contracted budget.
• Manages scope creep or out of scope work.
• Manages legal/contracting issues.

• Develops and presents internal scientific trainings.
• Conforms to SOPs and other Evidera/PPD requirements.
• Actively supports new product development and scientific innovation.

Experience using Computer-Assisted Qualitative Data Analysis Software (CAQDAS), such as Atlas.ti, NVivo, MAXQDA, Dedoose, etc. is required

Experience analyzing patient experience data is required, such as interviews, surveys, COA (clinical outcome assessment).

Experience managing multiple projects is required.

Experience in pharma or consulting companies is preferred.

Familiarity working in a clinical research environment is preferred.

• Deep understanding of qualitative research principles and familiarity with the conduct of qualitative research in the context of clinical trials
• Extensive knowledge of qualitative methods
• Advanced level understanding of operational and logistical challenges of ITR
• Well-developed communication skills and scientific writing skills
• Demonstrates strong analytical and problem-solving skills
• Demonstrates ability to independently manage, oversee, and/or lead a variety of project-related tasks and effectively delegates tasks to project team
• Demonstrates ability to manage client relationships
• Collaborative team member, capable of efficient multi-tasking

Why join us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference.

Apply today to help us deliver tomorrow's breakthroughs.