Description

Premier Research is looking for aSenior Clinical Data Manager to join our Functional Servicesteam. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.  

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.  
• We are Built by You. Your ideas influence the way we work, and your voice matters here.  
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.  

Together, we are Built for Biotech.Join us and build your future here.  

What You'll Be Doing:

• Assists in preparing clean databases by performing a review of clinical trial data through the CDMS or external data listings to ensure all captured data follows the rules outlined by the protocol and Data Management Plan
• Provide input to and review of Data Management Plans in support of clinical study deliverables
• Generates queries to appropriate internal or external personnel (e.g. - investigational sites, vendors, Clinical Research Associates, and client representatives) to resolve problematic data identified during every aspect of the data management process
• Reviews responses to queries for appropriateness, resolves any discrepancies, and modifies the database accordingly
• Supports the development of CRFs and edit check specifications per protocol and participates in user acceptance testing of CRFs and associated edit check specifications as required
• Prepares and maintains documentation related to CRF, edit check, and data listing testing including initial testing and follow-up testing to ensure that the changes have been made, as required

• Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field], or equivalent combination of education, training and experience 
• 3+ years of practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc).  
• Must have 2+ years of oncology study experience
• Demonstrates excellent English verbal and written communication skills 
• Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership 
• Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities 

Why Choose Premier Research?   

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.  
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. 
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful. 

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.   

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.  

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status. 

Description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.
We’re looking for a Senior Lead Data Manager join our Functional Services team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.


What you'll be doing:

• Responsible for independently leading end-to-end data management activities, including but not limited to, accurate and timely database design, database setup (including CRF and Non- CRF collection tools), data cleaning, and data management documentation
• Prepares the data management plans (DMP), data validation plans, completion guidelines, data management reports and other documents as required
• Participates in and coordinates study team review of CRFs for potential data collection, database structure, or data entry problems as well as to ensures all captured data follows the rules outlined by the protocol and data management plan
• Manages the development of the data validation plan per the protocol and ensures user acceptance testing of CRFs and associated edit checks are completed in accordance with project timelines
• Participates in and manages the progress of data cleaning activities including the generation and resolution of queries and discrepancies
• Ensures the accurate and timely reconciliation of third party data with Clinical Data Management System (CDMS) data.

• Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field], or equivalent combination of education, training and experience
• 5 to 7 years of practical experience leading database management activities and using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc). Alternately, must have proven experience in all primary job functions.
• Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc)

• Premier Research is more than a company–it’s a community of people that truly care
  about one another, about our clients, and about our mission of furthering research to
  improve the lives of patients in critical need.
• Our cultural anchors–Caring & Empathy, Empowerment, Aspiration, One Team–mirror
  the flexibility and trust that our team embodies. As a Premier team member, you have
  the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

About Imperva

Imperva is the comprehensive digital security leader on a mission to help organizations protect their data and all paths to it. With an integrated approach combining edge, application security, and data security, customers around the world trust Imperva to protect their applications, data, and websites from cyberattacks. Imperva Threat Research and our global intelligence community keep Imperva ahead of the threat landscape and integrate the latest security, privacy, and compliance expertise into our solutions.

Why Imperva? 

• We have experienced the following growth and achievements:
• Selling to over 6200 customers worldwide
• 500 partners in 100+ countries worldwide
• We are now a certified Great Place to Work®in Singapore.https://bit.ly/3Mi2a9E 
• Imperva has been named one of the coolest Cloud Security Vendors of 2023 by CRN!
• Imperva has been in the Leader’s Quadrant of the Gartner Magic Quadrant for 8 consecutive years in Web Application and API Protection
• Imperva is also a leader in the Forrester Wave for DDoS Mitigation Solutions in 2021 with the highest score in the “current offering” category

To be successful in this role, the person will need to perform the following responsibilities and possess the following qualifications.

You will be people-oriented by nature and enjoy working in a collaborative environment with your team. You should be driven toward constant improvement of the practice, the product and the organization.

Beyond your great attention to your clients, you will:

• Ensure that Imperva products are deployed and operating to meet customers’ expectations
• Provide customers with progress reports and other project documentation
• Troubleshoot technical issues with the help of the Support Team

To be successful, you should have:

• Strong technical skills and solid experience working with Internet Security, Networking Technologies and Relational Databases
• Experience delivering training to post-sales customers and partners
• Ability to scope, design, document and implement integration requirements
• Self-starter and independent, but also able to work within a team environment, helping out when needed on various deployments
• An aptitude for mastering new software applications
• Ability to understand and communicate concepts quickly, succinctly and accurately
• Highly motivated, driven and passionate about technology, training and customer success
• Able to plan for and deliver a project on a specific deadline

Successful candidates will have at least two of the following:

• Reasonable knowledge of Databases such as MS-SQL, Oracle, MySQL, DB2, Big Data or NOSQL platforms
• Reasonable knowledge of operating systems such as Linux, Windows, and VMware ESX
• Reasonable knowledge of Web Servers such as IIS, Apache and Tomcat

The qualifiers for the role include these items:

• 3+ years of experience in a Consulting or similar position
• Security clearance (or the ability to obtain) desired.
• Understanding the function of TCP/IP, HTTP, Load balancers, proxies and firewalls. Expertise is not required, but an overall understanding of how they work is necessary.
• Required travel (approximately 80%) within the region, and internationally when needed
• Fluent in English -- both written and verbal—required; Additional languages highly desired.
• Willing and capable of working from home

Our Company:

Imperva is an analyst-recognized, cybersecurity leader—championing the fight to secure data and applications wherever they reside. Once deployed, our solutions proactively identify, evaluate, and eliminate current and emerging threats, so you never have to choose between innovating for your customers and protecting what matters most. Imperva—Protect the pulse of you business. 

Learn more: www.imperva.com, our blog, on Twitter

Rewards:Imperva offers a competitive compensation package that includes base salary, medical, flexible time off and more. It’s an exciting time to work in the security space. Check out our products and services at www.imperva.com and career opportunities at www.imperva.com/careers

Legal Notice:Imperva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, ancestry, pregnancy, age, sexual orientation, gender identity, marital status, protected veteran status, medical condition or disability, or any other characteristic protected by law.  

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Description

Job Summary

The Financial Analyst is responsible for data collection and analysis. In this role, s/he will support the FP&A team in their mission to provide strategic planning, financial analysis, business intelligence and internal consulting across all O’Reilly business units.
The role primarily serves internal teams to O’Reilly; for example, Finance, Marketing, Sales and the Management team. The Financial Analyst, by producing clear and effective reporting, enables people to make informed decisions regarding issues critical to their business.

This role reports to the Director of Financial Planning and Analysis and is a remote position.

Essential Duties and Responsibilities

• Support the broader FP&A group with diligent and detailed reporting spanning various departments within the organization.
• Leveraging existing corporate systems and recommending enhancements, changes, or new systems to support SaaS KPIs and reporting.

• Performing variance and trend analysis between actual, budget and forecast targets for our SaaS business.Using trend analysis to forecast results for upcoming years in Adaptive Planning budgeting tool.
• Designing both recurring and ad hoc analysis on key business metrics and present findings in a clear and actionable format to give management visibility and support decision making.
• Working directly with functional VPs, Directors and Finance leadership to develop rolling financial forecasts and key performance indicators.

Knowledge, Skills and Abilities

• 2 - 3+ years experience in an analyst role.
• Strong quantitative skills.
• Excellent attention to detail.
• Ability to effectively communicate analysis and insight to all levels of the organization.
• Sufficient understanding and application of data presentation theory and best practices.
• A passion for problem solving through investigation and inquiry.
• Ability to work effectively in groups while comfortably executing tasks with a high level of independence.
• Advanced to Expert knowledge of Microsoft Excel.
• Sound understanding of reporting/data process flow.
• Understanding of basic business concepts, with a specific focus on financial and accounting principles.
• Workday Adaptive Planning, Oracle Business Intelligence, and Salesforce experience is a plus.

About O’Reilly Media

O’Reilly’s mission is to change the world by sharing the knowledge of innovators. For over 40 years, we’ve inspired companies and individuals to do new things—and do things better—by providing them with the skills and understanding that’s necessary for success.

At the heart of our business is a unique network of experts and innovators who share their knowledge through us. O’Reilly Learning offers exclusive live training, interactive learning, a certification experience, books, videos, and more, making it easier for our customers to develop the expertise they need to get ahead. And our books have been heralded for decades as the definitive place to learn about the technologies that are shaping the future. Everything we do is to help professionals from a variety of fields learn best practices and discover emerging trends that will shape the future of the tech industry.

Our customers are hungry to build the innovations that propel the world forward. And we help you do just that.

Learn more: https://www.oreilly.com/about/

Diversity

At O’Reilly, we believe that true innovation depends on hearing from, and listening to, people with a variety of perspectives. We want our whole organization to recognize, include, and encourage people of all races, ethnicities, genders, ages, abilities, religions, sexual orientations, and professional roles.