Title: Clinical Trial Planning Analyst
Duration: 1 year
Location: On site- Summit, NJ
Hours expected: 40 hours per week
Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.
Day to Day Duties/Responsibilities/ Scope of Work
- Lead the development and execution of study feasibility assessments:
- Responsible for conducting a comprehensive study feasibility assessment for all new trials. Ability to gather competitive intelligence data on the disease, standard of care, clinical trial benchmark/ competition and drug development landscapes and then apply this foundational knowledge to develop predictive analytics for the new trial.
- Engages with Regulatory, Commercial and other Celgene functions who evaluate Epidemiological data for the purposes of identifying incidence and prevalence of targeted patient population, inclusive of identifying global vs. regional/local standards of care.
- Facilitate the development and execution of country & site feasibility assessments:
- Collaborate with Clinical Research and Development (CR&D) Operations functions and cross-functional areas to identify, collect, integrate and analyze internal and external data sets that may better enable the projection of program/study milestones, identification of potential countries and sites, and facilitate subject recruitment and retention strategies and tactics.
- Responsible for driving protocol optimization activities through the utilization of competitive intelligence tools, digital/social media, web-listening and /or electronic medical records.
- Develop program/ study level recruitment and retention plans.
- Collaborates with Clinical Operations to develop program/study level subject recruitment and retention strategies. Ensure that strategies and tactics identified are practical, experienced-based and cost effective to execute, inclusive of identification, evaluation, selection and oversight of recruitment vendors.
- Identifies opportunities and fosters collaboration and partnership within organization. Drives Therapeutic Area or function specific interactions with external vendors such as CROs, Investigator networks, Site Management Organizations, hospital or university clinical research units, advocacy groups and recruitment vendors.
- Responsible for continuously identifying, assessing, introducing and ensuring the application of innovative tools/ technologies that enable a data-driven country/site selection and subject recruitment/retention processes.
- Supports the use of industry leading tools/templates/systems that enable those processes associated with Protocol Design, Industry Benchmarking, Project Management and Patient Recruitment Modeling / Forecasting.Qualifications/Requirements:
- BA/BS or equivalent degree preferably in life sciences or allied health field.
- Familiarity, and preferably proven mastery, of Simulation/Modeling/Algorithm /Forecasting capabilities to enable the creation and management of trial scenario planning and data analytics.
- Highly preferred that candidate has experience with the global drug development process/management of clinical studies and current knowledge of GCP/ICH Guidelines and Regulations.
- Advanced Clinical Trial Planning & Execution experience/expertise.
- Analytical mindset with attention to detail.
- Demonstrated administrative and project management abilities in relevant clinical development setting.
- Demonstrated experience managing and collaborating in a team/matrix work environment. Ability to direct activities and influence outcomes without direct authority. Ability to work independently.
- Good verbal, written and interpersonal skills - communication and presentation skills demonstrated in an international clinical research environment.
- Familiarity with process improvement methodologies (e.g. Six Sigma, Lean) is desirable, although not required.
Computer and systems literate; familiarity with Microsoft Office programs, including Microsoft Project, WORD, Excel, PowerPoint, SharePoint, Livelink, etc. Familiarity with Minitab or other Statistical computing software is highly desired.
Sthree US is acting as an Employment Business in relation to this vacancy.