Senior Scientific Advisor- UK (London) or US (various)
Senior Scientific Advisor (SSA) provides industry-leading scientific expertise in eCOA and use of IoMT (mobile sensor solutions) in clinical trials for the benefit of CRF Bracket’s clients. They also provide guidance and insight internally and drive the company’s scientific position through thought leadership activities.
SSA provides scientific services to clients to ensure they receive solutions that meet the scientific needs of their studies. This will include pre-sales activities to support solution recommendation and scientific input including: protocol review, disease indication-specific requirements, specifying key aspects of solution design, participating in proposal creation and bid defence activity. SSA also supports client services on key projects providing protocol review and solution design input, working to ensure high quality solutions in line with scientific best practices in collaboration with internal stakeholders such as Solution Architects and Delivery Teams. They provide recommendations on instrument migration to electronic format assisting Sales and Client Services in ensuring instruments are implemented according to author requirements and industry best practices.
SSA identifies, conducts, analyses and reports primary and secondary research to gain insights and understanding from patients and users of our solutions, and to increase the scientific leadership profile of the company externally.
Senior Scientific Advisor provides internal training, develops and disseminates best practices across the organization. They provide scientific insights for the Solution Architects in designing scientifically sound solutions and best practice guidance through training, design reviews and support.
Senior Scientific Advisor supports Product Management with scientific input into product design, features and capabilities.
This position will have a broad and diverse understanding of many different therapeutic areas and will represent the company at scientific conferences, webinars, publications, white papers and marketing activities and become recognized as an authority in our industry. The SSA will help to maintain CRF Bracket as externally-regarded scientific experts and leaders in eCOA
The position will act as an evangelist and driver for the science and art of eCOA creating a sense of purpose in the organization and appreciation of scientific best practices.
1. Proactive spokesperson for scientifically sound eCOA and patient eSource solutions with the goal of ensuring awareness of key scientific principles and requirements across the Sales, Operations, and Product Management organizations, thereby creating a sense of purpose and raising the overall quality of client-facing solutions and services.
2. Provide pre-sales support to business development and study teams to ensure high quality and scientifically credible proposals for new business awards, through: protocol review, identifying disease indication-specific requirements, specifying key aspects of solution design, participating in proposal creation and bid defence activity.
3. Provide support to client services study teams to ensure solutions meet the requirements of the protocol and satisfy good scientific principles and best practices, through: protocol review, scientific input to client design meetings and internal design meetings and solution review.
4. Stay on the leading edge of eCOA through research activities and collaboration with clients, KOLs and industry forums so that CRF Health can utilize the most up to date eCOA understanding in its client projects and appears as the best eCOA provider in the industry
5. Provide scientific insights and input to Product Managers to ensure new product development contains features and capabilities important to meet the scientific requirements of future engagements.
6. Design and execute research projects in the area of eCOA and patient research.
7. Present and promote CRF Bracket as scientific thought leaders in the industry, including active participation in industry forums, conferences, delivering speeches, webinars and publications and marketing collateral on selected topics to raise awareness of CRF Health as a leading eCOA provider
8. Maintain comprehensive knowledge of the most recent regulatory requirements in the European Union and United States for clinical outcome assessments (eCOA) and the implementation of such requirements in clinical research.
9. Develop new and improved best practices for eCOA so they can be utilized in clinical trials by Solution Architects and other Scientific Advisors and are more broadly available for Operations and R&D to be used in raising their awareness of CRF Health’s business so that their work meets client needs.
10. Provide training to new staff in collaboration with Learning and Development to provide the staff with a basic understanding of clinical trials and CRF Health’s role.
Other responsibilities will be assigned as required.
DECISION MAKING AND INFLUENCE
1. Provides expert input to internal teams and external customers, advising and influencing on best practices
2. Able to research and provide a scientific position on aspects of eCOA science when requested by internal teams or clients
3. Steers product management, where appropriate, in product design to ensure scientific requirements are taken into account
4. Provides a senior and respected internal authority on matters of eCOA science.
1. Higher degree in a Science or other appropriate subject
2. Seven years of experience in the field of clinical research, preferably in more than one therapeutic area or indication
3. Experience in eCOA scientific aspects, including one or more of the following: selection of instruments, instrument development and validation, design of diaries or instruments, migration of instruments from paper to electronic, involvement in trials that use eCOA in scientific or clinical role
4. In depth understanding of EU and US regulatory requirements for COA and eCOA used in clinical trials
5. Ability to quickly develop expertise in new fields through literature research and acquiring a network of useful specialists
6. Ability to instill confidence when providing client consultation. Ability to take feedback and handle opposing views and find resolutions for the benefit of the study
7. Strong analytical and problem-solving skills
8. Ability to manage time between multiple concurrent projects
9. Strong interpersonal skills along with excellent verbal and written skills
10. Confident presenter
11. An effective, positive team player who can work across stream and teams and in a matrix environment
12. Can easily communicate with clients and all levels within their organizations
13. Travel will be required in this position
1. Experience in qualitative research methods
2. Author of a number of peer reviewed scientific publications
Direct Reports: 0 currently, but this position may have a small number of direct reports in future.
Indirect Reports: 0
• International: Yes
• % Travel: 10%
Budget Responsibility: None
At Signant Health, we help you connect patients and researchers to ensure data reliability, with proven solutions that simplify every step of the patient journey. Our deep therapeutic area expertise, agile technology and service scale enable us to minimize risk, innovate, and support your important work. We seek speed, efficiency and reduced variability to help you extend the reach of drug development, expand patient opportunities and improve data quality helping you bring life-changing therapies to our families and communities around the world.