Principal Medidata Programmer
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POST DATE 9/10/2016
END DATE 10/18/2016
JOB DESCRIPTIONPRINCIPAL MEDIDATA PROGRAMMER
Principal Clinical Systems Developers (Medidata)
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 Principal Clinical Systems Developers (Medidata) to join our team. These are full-time, salaried roles 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.
* 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
* Review SCD/protocol to determine data collection requirements and evaluate against data standards.
* Responsible for creation, maintenance and communication of the Study Build Timelines.
* Track performance of Study build activities to ensure deliverables are met and risks are proactively identified and mitigated.
* Understand study data collection needs and able to translate the information into data specifications to provide to the offshore team for buil
* 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.
* Mentor offshore staff on EDC database development as needed
* Fundamental knowledge of multiple clinical database systems (ie Rave, Inform, eCOS etc)
* Perform detailed Quality Review/Test/UAT of database structures
* Knowledge of SDTM data standards
* Communicate project status to other managers and departments
* Work to promote consistent operations, efficient use of resources, knowledge exchange and best practices.
* 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.
* Adhere to company and departmental SOPs and standards
* For Clinical Systems Developers focused on Custom Function development: Application Development experience with C# and .NET
* Proficient in Rave and SAS
* Proficient in Rave and SAS reporting capabilities
* Familiar with Rave migrations and management of migration work
* Resourcing large pipelines of work 30+ FTEs and over 200+ studies
At Chiltern, you ll join a team of like-minded individuals headed by some of the most dynamic and influential leaders in drug and medical device development today. You ll work on cutting-edge global research projects in a fast-paced but collegial atmosphere where you ll have the opportunity to make meaningful and acknowledged contributions. You ll have opportunities to grow personally and professionally and abundant room for advancement along with generous incentive programs.
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.
Chiltern is an equal opportunity employer, M/*F/*D/*V
DUTIES & RESPONSIBILITIES
Principal Level Roles include the following Additional responsibilities:
* Ability to troubleshoot systems issues and provide resolution
* Attend audit meetings as necessary
* Encouraged to attend/participate in Industry meetings
* Mentor onshore/offshore staff
* Ability to learn/perform cross functional tasks (ie writing SDTM mapping specs, SAS, etc.)
Principal Clinical Systems Developer University/College degree or relevant experience along with at least 3 years of experience as a Medidata Programmer
Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.
Email Jim Doyle