Clinical Trial Planning Analyst
Posted on Feb 5, 2019 by Sunrise Systems, Inc.
Job Title: Clinical Trial Planning Analyst
Job Id: 19-01113
Location: Summit, NJ 07901
Duration: 12 months
Position Type: Hourly contract Position (W2 only)
- Support study planning and execution through the conduct of feasibility assessments that drive country/site selection decisions as well as define study timelines, projected enrollment rate and study-specific recruitment and retention strategies.
- Core member of the Study Team.
- Work in close collaboration with CR&D, PL, GCRDO, Medical Affairs and Market Insights.
- 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 Client 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.
- Responsible for defining all influencing factors, analyzing the aggregate data and for developing a projected rate of recruitment as well as multiple patient enrollment models for new and on-going clinical programs/ trials.
- Participate in early identification of potential risks to study objectives and contributes to the development of risk specific contingency plans to promote proactive remediation.
- 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.
- Responsible for developing program/study specific investigator/site lists, that promote data-driven methodologies, and utilize performance, quality and cycle time measures.
- Collaborate with Clinical Operations and CR&D on the preparation and execution or site feasibility assessments.
- Analyzes and identifies trends, variations, successfully demonstrated practices, potential problems and opportunities for process improvement.
- 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.
- Works with local affiliates to ensure compliance with federal and country/local regulations regarding study start up and enrollment strategies.
- Provides project management for the implementation of subject recruitment and retention strategies related to recruitment and media vendors including timelines and budget.
- Participates in root cause analysis and makes adjustments to retention/recruitment planning.
- 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.
- 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, Live link, etc.
- Familiarity with Minitab or other Statistical computing software is highly desired.
Direct: - Email:
Sourabh Agrawal - Lead - Talent Acquisition
Direct: - Email:
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.
At Sunrise Systems, we provide cost effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.
Our collective business experience spans over two and a half decades and ranges from:
- Business, management, and technical fields
- Information technology consulting and software solutions.
- Providing strategic support for the developmen