Clinical Data Manager, Senior

United States of America, Arizona, Tucson

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Job Summary:

Mentors and provides guidance to CDx Pharma Services Data Analysis Technician I team members. Performs LIMS technology and data management activities in CDx pharma services following established procedures and provides Laboratory Information Management Systems (LIMS) technical troubleshooting, LIMS configuration, LIMS user management and training, data transfer (including initiating and preparing) to the CDx Pharma clients, and querying and data analysis of business related data from multiple sources. Creates and provides training to data management staff for highly complex technical process and techniques.  

Distinguishing Characteristics:

The employee is a self-directed individual that has the skills and aptitude to mentor and guide team members in complex technical methodologies and techniques. Is proficient with JSON, SQL, NoSQL, HTML, XML, and CSS at or very near expert level.

Responsibilities:

Mentors and provides guidance to CDx Pharma Services Data Analysis Technician I team members. Performs LIMS technology and data management activities in CDx pharma services following established procedures and provides Laboratory Information Management Systems (LIMS) technical troubleshooting, LIMS configuration, LIMS user management and training, data transfer (including initiating and preparing) to the CDx Pharma clients, and querying and data analysis of business related data from multiple sources. Creates and provides training to data management staff for highly complex technical process and techniques.  

Distinguishing Characteristics:

The employee is a self-directed individual that has the skills and aptitude to mentor and guide team members in complex technical methodologies and techniques. Is proficient with JSON, SQL, NoSQL, HTML, XML, and CSS at or very near expert level.

  • Works under moderate guidance to support research programs by assisting with script/tool/web coding, programming and development data management and simple analyses.
  • Performs bioinformatics data analyses under moderate guidance, including database querying, sequence alignment and assembly, analysis of genetic variations, phylogenetic and comparative genomic analysis, gene prediction and protein function analysis, biological pathway analysis, classifying disease subtypes, modeling and validating pathogenic mechanisms, pattern recognition and machine learning.
  • Develops new data interpretation and extraction methods applicable to proprietary technology platforms (such as chips, strips, and PCR instruments). Proficient coder and scripter.  Implements and evaluates new analytical methods on internal data.
  • Develops, tests, and deploys small RUO client tools and web applications, especially for data access, management, and custom analyses.  Learns and supports assigned tools among commonly used informatics tools, including sequence analysis programs, web applications, and open source RUO tools.
  • Supports data management and access solutions under supervision.
  • Capable of rapidly developing scripts and simple databases to support research studies.  Able to retrieve data from public sources, integrate with internal stores, and advise on interpretation with supervision.
  • Presents at internal meetings for project teams, as appropriate, and share in activities of informatics education within and between departments.
  • Work involves troubleshooting and resolving difficult problems in creative ways. Takes a new perspective on existing solutions, exploring and implement new concepts and methodologies.
  • Decisions impact project team(s) and/or broader organization. Inappropriate decisions may have an impact, causing delay in operations, a financial expense or customer or user dissatisfaction.
  • Leads development of CDx Pharma Services clinical study test methods, scoring methodology definitions, internal study protocols, and file format specifications (FFS).
  • Defines and configures proposed changes to the LIMS system.
  • Reviews and approves test scripts for LIMS modifications and changes.
  • Performs other duties as assigned.

Qualifications

  • Required: Bachelor's Degree
  • 5 Years minimum of experience in data management or related  fields.
  • or equivalent undergraduate degree is required

Preferred Maters Degree or Bachelor's Degree in Computer Science:

 Knowledge, Skills, and Abilities:

Advanced Understanding of Javascript, JSON/XML, SQL, NoSQL, HTML, and CSS

Knowledge of Good Clinical Practices (GCP), regulatory and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines as applicable to data management.

Demonstrated leadership behaviors/abilities that are focused on maintaining a positive, results-oriented approach, building partnerships and alignment across functions and regions, and communicating in an open, balanced and objective manner.

Knowledge of clinical research activities is favorable.