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.