Role at a glance
- Salary
- Not Disclosed
- Location
- Remote - North Carolina, United States
- Work arrangement
- Remote
- Employment
- Full-time
- Experience
- Doctorate in a life sciences or social sciences discipline (psychology, epidemiology, health services, public health, etc…) and more than 3 years’ experience in relevant field
- Education
- In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will...
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Role Summary
Independent Principal Investigator role on in-trial research (ITR) projects within the Patient-Centered Research group, overseeing project delivery, delegating tasks to junior scientific staff, and holding scientific responsibility for project completion. The role also carries client development and sales responsibilities.
What You'll Do
- Oversee all aspects of project delivery and delegate project management tasks to junior scientific staff
- Provide scientific leadership to team members and advise on best methods in project plans and design
- Develop and maintain client relationships and help clients prepare for and attend regulatory meetings
- Write proposals, bring in proposal leads, and close sales
- Manage internal timelines, staff hours and budgets per project, and scope creep
- Present scientific work in peer-reviewed journals and at professional meetings
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
A doctorate or master’s degree in a life or social sciences discipline with several years of relevant experience, plus CAQDAS software and patient experience data analysis skills.
Required
- Doctorate in a life sciences or social sciences discipline and more than 3 years’ experience in relevant field, or Master’s degree in a...
- Experience using CAQDAS software such as Atlas.ti, NVivo, MAXQDA, Dedoose
- Experience analyzing patient experience data such as interviews, surveys, or COA (clinical outcome assessment)
- Experience managing multiple projects
- Deep understanding of qualitative research principles and familiarity with conducting qualitative research in clinical trials
- Extensive knowledge of qualitative methods
- Advanced understanding of operational and logistical challenges of ITR
- Well-developed communication and scientific writing skills
Preferred
- Experience in pharma or consulting companies
- Familiarity working in a clinical research environment
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
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
Patient-Centered Research, In-trial qualitative research
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.
Position Overview:
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):
Science
- 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.
Strategy/Consulting
- 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.
Financial & Business Development
- Brings in proposal leads.
- Writes proposals and managing proposal writing process.
- Closes sales.
- Meets annual target utilization rate of 60%, unless otherwise specified.
Project Management
- 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.
PCR Operations Support
- Develops and presents internal scientific trainings.
- Conforms to SOPs and other Evidera/PPD requirements.
- Actively supports new product development and scientific innovation.
Hiring requirements:
Education requirements
Doctorate in a life sciences or social sciences discipline (psychology, epidemiology, health services, public health, etc…) and more than 3 years’ experience in relevant field
Master’s degree in a life sciences or social sciences discipline (psychology, epidemiology, health services, public health, etc…) and more than 5-7 years’ experience in relevant field
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Experienced requirements:
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.
Personal Skills & Competencies:
- 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.
About the company
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.