Senior RWE (Real world Evidence) Operations Analyst
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...
ClinChoice is searching for a Senior RWE (Real world Evidence) Operations Analyst to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Primary Duties
Supports the execution of observational research studies within time, budget, and quality standards for a variety of studies, including but not limited to: natural history of disease, population characterization, assessment of treatment patterns and unmet need, development of external comparators, benchmarking of clinical outcomes, comparative safety and effectiveness research, and post-authorization studies Required Experience: Support initiatives including identification of project tasks, clear milestones, assignment of project responsibilities, schedules, plans, resources, and status reports Coordinate and maintain relevant documentation and follow necessary processes in accordance with program needs (e.g., sections of Project Management Plan, risk and issue management process, consulting agreements, vendor, and purchase order management process) Coordinate the generation of project or program level reporting and monitor metrics for senior management, disseminate reports to relevant stakeholders Ensure project lead has timely and accurate data on areas including cost, schedule, scope, change orders, and quality to support better decision-making Prepare correspondence including meeting minutes, project status reports, and training materials for project team or program Develop and deliver trainings in content related to observational research to cross-functional stakeholders Manage and coordinate core file reviews and support audits Coordinate onboarding of new team members or program staff Contribute to the development of processes, systems, and training aimed at increasing the efficiency, quality, and impact of functional activities Technical Expertise Experience with Smartsheet for project tracking and timeline visualization Capable of developing and maintaining tracking systems and dashboards to monitor project metrics. Ability to quickly learn and adapt to new software and digital tools. Subject Matter Expertise Understanding of observational research methodologies Minimum Qualifications Bachelor’s degree in Life Sciences or related field desirable. Typically requires 0-2 years of prior relevant experience or equivalent combination of education, training, and experience. Understanding and/or experience in observational research, RWE and/or RWD preferred General knowledge of clinical trial and observational research principles, designs, conduct and skill in applying applicable clinical research regulatory requirements Demonstrated ability to function with an increasing level of autonomy and to develop productive cross functional collaborations in a matrix environment Ability to manage priorities and performance targets Additional requirements may include: Experience with business intelligence or visualization tools (Tableau, Power BI)
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #Senior#Contract
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Senior RWE (Real world Evidence) Operations Analyst
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...
ClinChoice is searching for a Senior RWE (Real world Evidence) Operations Analyst to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Primary Duties
Supports the execution of observational research studies within time, budget, and quality standards for a variety of studies, including but not limited to: natural history of disease, population characterization, assessment of treatment patterns and unmet need, development of external comparators, benchmarking of clinical outcomes, comparative safety and effectiveness research, and post-authorization studies Required Experience: Support initiatives including identification of project tasks, clear milestones, assignment of project responsibilities, schedules, plans, resources, and status reports Coordinate and maintain relevant documentation and follow necessary processes in accordance with program needs (e.g., sections of Project Management Plan, risk and issue management process, consulting agreements, vendor, and purchase order management process) Coordinate the generation of project or program level reporting and monitor metrics for senior management, disseminate reports to relevant stakeholders Ensure project lead has timely and accurate data on areas including cost, schedule, scope, change orders, and quality to support better decision-making Prepare correspondence including meeting minutes, project status reports, and training materials for project team or program Develop and deliver trainings in content related to observational research to cross-functional stakeholders Manage and coordinate core file reviews and support audits Coordinate onboarding of new team members or program staff Contribute to the development of processes, systems, and training aimed at increasing the efficiency, quality, and impact of functional activities Technical Expertise Experience with Smartsheet for project tracking and timeline visualization Capable of developing and maintaining tracking systems and dashboards to monitor project metrics. Ability to quickly learn and adapt to new software and digital tools. Subject Matter Expertise Understanding of observational research methodologies Minimum Qualifications Bachelor’s degree in Life Sciences or related field desirable. Typically requires 0-2 years of prior relevant experience or equivalent combination of education, training, and experience. Understanding and/or experience in observational research, RWE and/or RWD preferred General knowledge of clinical trial and observational research principles, designs, conduct and skill in applying applicable clinical research regulatory requirements Demonstrated ability to function with an increasing level of autonomy and to develop productive cross functional collaborations in a matrix environment Ability to manage priorities and performance targets Additional requirements may include: Experience with business intelligence or visualization tools (Tableau, Power BI)
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #Senior#Contract