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Job Details

Principal Medidata RAVE Developer

Company: Chiltern
Location: Anywhere in the U.S. or Canada
Reference: 152641
Closing Date: 24 Mar 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Chiltern is hiring for a Principal Medidata RAVE Developer. These are permanent, salaried positions that can be done remotely from anywhere in the U.S. or Canada.

Requirements:

Job Background

Principal Medidata RAVE Developer

Remote from anywhere in the U.S. or Canada

When you’re ready to join a company that’s as dedicated to excellence as you are, THINK CHILTERN.

We are seeking a Principal Medidata RAVE Developer to join our team.  This is a full-time, salaried role that can be done remotely/home-based in the USA or Canada.  In this role, the selected candidate will provide programming/study start-up management or other support and assist CDM managers in daily technical operations. Respond to and solve technical oriented problems in a timely manner, as appropriate for the position.

 

Chiltern is a leading midsized provider of comprehensive clinical research and development services with offices in more than 30 countries and a customer base comprised of some of the world's top pharmaceutical, biotech and medical device companies. As a forerunner in medical device and drug-device combination trials with notable capabilities in pharmaceuticals and biologics, Theorem offers deep expertise in a broad range of therapeutic areas and in all phases of development. With some of the industry's top scientists and most advanced clinical analytics capabilities, CHILTERN ensures smooth-running, successful trials. For the full-service, right-size global research partner, don't think twice. THINK CHILTERN.

Role description:

  • Subject Matter expert in CDASH implementation and Rave study/library build and best practices.
  • Standards Librarian for 1 (or more) Therapeutic Area (TA), mainly focusing on Data Collection Standards.
  • Member of the Standards Development Working Group for 1 (or more) Disease Area (DA).

Respnsibilities

1) Attend project team meetings to provide input and state issues from a CDM programming perspective. Ensure project team are co-operating and communicating to achieve success. Establish positive client interaction and maintain good communication.
2) Review SCD/protocol to determine data collection requirements and evaluate against data standards.
3) Responsible for creation, maintenance and communication of the Study Build Timelines.
4) Track performance of Study build activities to ensure deliverables are met and risks are proactively identified and mitigated.
5) Understand study data collection needs and able to translate the information into data specifications to provide to the offshore team for build
6) Review study requests for new database structures including evaluation of requests for consistency with standards and best practices. Request input from Standards SME as needed.
7) Mentor offshore staff on EDC database development as needed 
8) Fundamental knowledge of multiple clinical database systems (ie Rave, Inform, eCOS etc)
9) Perform detailed Quality Review/Test/UAT of database structures
10) Knowledge of SDTM data standards
11) Communicate project status to other managers and departments
12) Work to promote consistent operations, efficient use of resources, knowledge exchange and best practices.
13) Familiar with contractual obligations of study and scope of project. If scope of project is increased or impacted, determine the consequent result on timing and cost with findings to be reported to CDM Director and Project Management.
14) Adhere to company and departmental SOPs and standards

 

Relations:

  • Under the guidance of the Clinical Data Standards Head, and Data Collection Lead.
  • Members of the Standards Management Office, incl. other Standard Librarians.
  • Cross-functional group (incl. DM, Stats, Clinician, etc.) on the Standards Development Working Group.
  • Vendors supporting the Data Standards initiative, e.g. for EDC Library build or metadata management.

 

Skills:

  • University/College degree or relevant experience along with at least 3 years of experience as a Medidata RAVE Developer.
  • RAVE Safety Gateway experience is preferred, but not required.

Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

Salary

Negotiable

Position Type

Permanent
Full Time

Contact

Email Jim Doyle - James.Doyle@Chiltern.com
484 679-2497

Apply for this job: Principal Medidata RAVE Developer

Contact Information:

Address:  Pennsylvania, USA
1016 W 9th Ave, King of Prussia, United States
PA 19406
USA
Website:  Visit Our Web Site

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