DaVita Inc.
Associate Director/Director, Clinical Data Systems
DaVita Inc. - Westlake Village, California, United States, 91361
Work at DaVita Inc.
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Overview
The following information aims to provide potential candidates with a better understanding of the requirements for this role.
Position: Associate Director/Director, Clinical Data Systems
Location:
Westlake Village, CA
Job Id: 111279
# of Openings: 1
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
Position Summary:
The Associate Director/Director Clinical Data Systems will be responsible for specifying, developing, validating and executing programs related to clinical systems and applications. The position will be responsible from start to finish Medidata programming activities to align on and drive data collection requirements for one or more studies.
This position will work in a team to develop databases in which clinical data are captured and processed for analysis and reporting. This role requires the ability to work independently and to take initiative in managing delivery timelines. This position plays a critical role on our study teams; a quality, timely database development is instrumental to the company's and study's success.
This position is remote.
Essential Duties and Job Functions:
Participate in the development, maintenance and compliance of database builds and Electronic Data Capture (EDC) standards in support of clinical studies, including but not limited to Edit Checks and CRF modules
Act as a resource for database issues and provide problem-solving with clinical database technology, capabilities and functionality
Maintain all project documentation as required by SOP and processes
Recommend process improvements leading to more efficient and timely database builds and post-production changes
Be an active part in multiple global project teams and collaborate with internal team members
Manage programming data imports/exports from various sources, develop complex subject profiles/cohorts, and creating listings in multiple output formats like SAS, PDF and XML
Knowledge, Experience and Skills:
Bachelor's degree in computer science, mathematical science, life science, or related field
10+ years working in GXP related environments/pharmaceutical industry
10+ years of programming experience in Medidata Rave in the clinical research environment preferred, but not required
Experience with SQL scripting/Clinical SAS programming
C#, or similar, programming experience preferred, but not required
Flexible and able to support a variety of studies
Ability to act independently and with initiative
Knowledge of EU regulatory agencies, FDA/ISO guidelines and industry standard practices regarding data management
Pay Range:
$144,000 - $264,000 per year
Apply for this Position
#J-18808-Ljbffr
Position: Associate Director/Director, Clinical Data Systems
Location:
Westlake Village, CA
Job Id: 111279
# of Openings: 1
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
Position Summary:
The Associate Director/Director Clinical Data Systems will be responsible for specifying, developing, validating and executing programs related to clinical systems and applications. The position will be responsible from start to finish Medidata programming activities to align on and drive data collection requirements for one or more studies.
This position will work in a team to develop databases in which clinical data are captured and processed for analysis and reporting. This role requires the ability to work independently and to take initiative in managing delivery timelines. This position plays a critical role on our study teams; a quality, timely database development is instrumental to the company's and study's success.
This position is remote.
Essential Duties and Job Functions:
Participate in the development, maintenance and compliance of database builds and Electronic Data Capture (EDC) standards in support of clinical studies, including but not limited to Edit Checks and CRF modules
Act as a resource for database issues and provide problem-solving with clinical database technology, capabilities and functionality
Maintain all project documentation as required by SOP and processes
Recommend process improvements leading to more efficient and timely database builds and post-production changes
Be an active part in multiple global project teams and collaborate with internal team members
Manage programming data imports/exports from various sources, develop complex subject profiles/cohorts, and creating listings in multiple output formats like SAS, PDF and XML
Knowledge, Experience and Skills:
Bachelor's degree in computer science, mathematical science, life science, or related field
10+ years working in GXP related environments/pharmaceutical industry
10+ years of programming experience in Medidata Rave in the clinical research environment preferred, but not required
Experience with SQL scripting/Clinical SAS programming
C#, or similar, programming experience preferred, but not required
Flexible and able to support a variety of studies
Ability to act independently and with initiative
Knowledge of EU regulatory agencies, FDA/ISO guidelines and industry standard practices regarding data management
Pay Range:
$144,000 - $264,000 per year
Apply for this Position
#J-18808-Ljbffr