- Research Triangle Park, NC
Cenduit LLC is the largest IRT (interactive response technology) specialist in the world with the expertise to empower study sponsors for success by implementing a completely personalized system that puts them in control of their clinical trials. Cenduit was founded in May 2007 and emerges from a robust tradition of clinical development and supply chain expertise from two world leaders, Quintiles and Thermo Fisher Scientific.
Meeting the needs of investigator sites and patients, Cenduit offers clinical supply chain intelligence and clinical operations know-how through its IRT-driven services: rapid study start-up software, patient randomization (RTSM), patient reminders, drug supply management, and eClinical integration. Cenduit has over 500 experts worldwide in the US, UK, Switzerland, India and Japan, with clinical trial experience in more than 100 countries, interacting with more than 600,000 patients at more than 32,000 sites.
Cenduit is looking for a Scientific Advisor to join a newly-formed, fast-growing entrepreneurial team building cutting edge clinical outcomes assessment technology for clinical trials. This role is responsible for clinical and scientific oversight of the product line from planning and design to delivery and support. This challenging role will require expertise in patient reported outcomes, international regulatory processes, collaboration with internal cross-functional teams, client presentations and public speaking.
The ideal candidate must thrive in a dynamic, start-up environment while also being grounded by the scientific process and a commitment to quality. Previous experience with international clinical trials and eClinical software as a service (SaaS) highly preferred.
- Primary responsibility is to ensure Cenduit's clinical outcomes assessment products meet the clinical and scientific needs of all stakeholders across multiple therapeutic areas.
- Establish and participate in a network of eCOA thought leaders.
- Own the relationship with PRO instrument owners and copyright holders; support licensing of instruments when needed.
- Participate in eCOA proposal development and bid defence presentations.
- Provide recommendations and support to internal and external stakeholders on eCOA best practices, optimal use, scientific and regulatory considerations, and validation of COAs/eCOAs in support of labeling claims.
- Support product marketing in the development of clinical case studies, publications and other examples of research using Cenduit's eCOA solutions.
- Attend and participate in industry conferences and events.
- Support product management by reviewing and identifying clinical and scientific product requirements.
- Must be able to influence and be credible at a senior level among clinical experts and business leaders within Cenduit and client organizations.
- Proactive, driven and excellent time management skills
- Strong verbal, written and interpersonal communication skills
- Excellent presentation skills to internal and external audiences
- Strong sense of customer focus and customer awareness
- Ability to understand customer requirements and articulate and devise the most appropriate solutions
- PhD in a medical field or MD required
- Experience with clinical research required; clinical trial experience preferred
- At least 2 years working within the life sciences, pharmaceutical or eClincal industry
- Experience with clinical outcomes assessments
- Experience with eClinical technology
- Security - we are celebrating our 10th year of continued growth and success!
- Opportunities for career advancement and professional growth
- Medical insurance effective day one
- Dental and Vision insurance
- Medical & Dependent Flexible Spending Accounts
- Health Savings Account and PPO Options
- Employer paid Short-Term Disability & Long-Term Disability insurance
- Employer paid Basic Life insurance and Accidental Death & Dismemberment insurance
- 401k with generous company match
- Employee Assistance Program
- Adoption Reimbursement Program
- Educational Reimbursement Program
- Employee Referral Program
- Parental Leave
- PTO and paid holidays
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