Project Manager - In-trial Qualitative Research

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Research Associate III (Project Manager) - In-trial Qualitative Research

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Evidera’s Patient-Centred 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:

As a Research Associate III – In-trial qualitative research studies, you will have the opportunity to learn and grow your skills by owning the following tasks:

Science

• Assist with or oversee ITR studies using relevant qualitative methodologies (content and/ or thematic analyses, framework analysis, longitudinal qualitative analysis, or mixed methods)
• Prepare near-final drafts of interview guides, training materials (sites, interviewers, coders), qualitative analysis plans, code books, report sections, and manuscripts.
• Maintain familiarity with current scientific literature and regulatory standards for qualitative research. May co-author presentations for scientific conferences and manuscripts for scientific journals.
  
  

Project Management

• Assume primary responsibility for day-to-day tasks related to the project, including making decisions related to the project either alone or in conjunction with more senior staff.
• Involved with client communication, and may be primary point of contact with client.
• Efficient delegation and communication with project team, and ensures proper staffing and oversight on project. Able to track timelines and keep project team and Principal Investigator (PI) informed in order to complete work within the expected timeframe.
• Know project management systems (electronic and paper filing, SOP requirements, finance office practices, etc.) and implement as required.
• Oversee patient recruitment for ITR studies, coordinate with the contract research organizations (CROs) in charge of the clinical trials and manage tasks conducted by more junior staff.
• Travel 0-10% of the time.
  
  

Financial & Business Development

• Communicate effectively with clients.
• Write and/or review project proposals, including budgets.
• May interact with clients to win new business.
  
  

Patient-Centered Research Support

• Provide leadership, oversight, mentoring and guidance to junior staff in a formal and informal role
• May supervise employees (up to and including Research Associate II)
• May attend scientific conferences for professional development/training
• Conforming to SOPs
• Conduct and participate in the training of junior staff and new hires
• Participate in staff recruitment efforts (phone screening, interviewing, attending presentations, etc.)
  
  

Role Requirements:

Education, Professional Skills & 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; Previous consulting experience is preferred
• Master’s degree in a life sciences or social sciences discipline (psychology, epidemiology, health services, public health, etc…) and more than 2-3 years’ experience in relevant field; Previous consulting experience is preferred
• Atlas.ti, NVivo, familiarity with the use of AI for qualitative analysis
  
  

Personal Skills & Competencies

• Well-developed communication skills and scientific writing skills
• Strong analytical and problem-solving skills
• Ability to independently manage, oversee, and/or lead a variety of project-related tasks and effectively delegates tasks to project team
• Ability to manage client relationships
• Collaborative team member, capable of efficient multi-tasking
  
  

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.