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1086#Senior Clinical Data Manager_Cardiovascular(Remote)

United States

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 Clinical Data Manager Consultant 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.   

Job Summary:

This role will be providing general DM support role tasks. Perform EDC validation UAT, data lsitings review, data issues tracking and query management, external data reconciliation, data listings review coordination. Here are some JD listed below:

  • Perform EDC (electronic data capture system) build validation and update supporting documentations, included but not limited to: eCRF design specification, edit check documents, UAT test/issue logs, and UAT summary report.
  • Assist oversight of EDC users and other Clinical databases user access management, including but not limited to, compiling master user lists and reviewing appropriate activating/deactivating user accounts.
  • Accountable for on-time and comprehensive review of clinical study data listings
  • Oversees and/or performs the reconciliation of key data points collected in EDC with other sources such as the Safety Database and Third Party/External Data Vendor systems.
  • Support the design and testing of technical CDM components including eCRFs, Edit Checks, reports, and listings.
  • Manages the effective communication of data issues and discrepancies to study sites via the query management process.
  • Escalates relevant issues to lead data manager and appropriate study team as needed to facilitate timely resolution. Investigates and analyzes possible solutions using experience, judgement and precedent, has autonomy to propose alternatives and exercises judgement based on experience.
  • Experience managing study-level data management activities and working with external vendors.
  • Familiarity with clinical data systems (e.g., Medidata RAVE, Oracle Clinical, Veeva) and industry data standards (e.g., CDISC, SDTM).

Qualifications & Experience:

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Computer Science, or a related field.
  • 5+ years of experience in clinical data management.
  • Experience in Cardiovascular required. 
  • Strong knowledge of clinical trial processes, regulatory requirements, and
  • Hands-on experience with EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault, etc.).
  • Excellent communication, problem-solving, and leadership skills.

 

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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