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Clinical Programmer Analyst - B
Alameda, California
Contract Position
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Applied on September 28, 2020
Job Id #42782 Posted August 6, 2020


Position Summary from Legacy System

  • This position is responsible for implementation of data management activities in support of clinical trials, including: design and maintenance of clinical databases using Oracle Clinical or other major Clinical database, SAS; review of data collection forms; generation of data tables, listings and reports; establishment and documentation of data management processes.  
  • Designs, programs, installs and maintains quality databases for the clinical studies.
  • Provides technical support for assigned databases responding to database and user problems.
  • Determines causes and resolutions of problems when they arise to ensure continued operations.
  • Writes user documentation, functional and technical specification documents.
  • Ensures data validation specifications are comprehensive, appropriate, and are created according to the company procedures and requirements.
  • Extracts clinical study data from the databases and prepares data for statistical analyses, develops programs to create data listings and summary tables, provides programming support needed to analyze the data.

Additional Main Responsibilities from Legacy System

  • Ensure that database design is consistent with 21 CFR part 11.
  • Provide input to the development of case report forms, in conjunction with Clinical Research and Clinical Data Specialists.
  • Annotate CRFs and develop study clinical databases using Oracle Clinical or other clinical database.
  • In conjunction with Clinical Data Specialists, write study specific data entry work instructions.
  • In conjunction with the Validation team, ensure databases are validated and data entry training has been provided before the database is activated.
  • With Clinical Research staff and Clinical Data Specialists, contribute to the development of data edit check rules.
  • Program edit checks and provide documentation of data validation checks.
  • Contribute to Data Management Plan to document study specific data management activities that will ensure data integrity.
  • Participate in efforts to standardize, streamline and enhance DM processes, write SOPs.
  • Generate data tables, listings, reports, and ad hoc queries from Oracle Clinical and related databases using SAS or other software tools.
  • Maintain clinical databases according to change control procedures.
  • Oversee query generation and resolution and resolve issues with validation rules.
  • Provide programming support to the CRAs as needed.
  • Act as a resource for database related questions.
  • Prepare and review reports clearly communicating results in a manner suitable for both technical and nontechnical customers.
  • Support software requirements including development, maintenance and validation of software for Clinical Affairs Group as required.
  • Provide general (statistical) software support to the Clinical Affairs Group and other departments as required.
  • Collaborate with company wide groups as and when required.
  • Provide supervision to staff, including setting direction and goals, performance reviews and development plans as and when required.
  • Must be able to tap into appropriate resources when specific expertise is needed that cannot be achieved individually.
  • Support relevant training activities, presenting data and results in a suitable format.

Accountability/Scope/Budget from Legacy System

  • This field includes Accountability/Scope/Budget information imported from Legacy System.
  • Support of mission critical Clinical systems Completes given projects on time, accountable for the project timelines  Clearly communicates with management and peers   Assumes responsibility for completing individual and team assignments and tasks         Reliable attendance is required for this position  Individual contribution should make a measurable difference to the department and the business.
  • Works on technical problems of moderate scope where analysis of the system requires technical expertise.
  • Exercises judgment to achieve desirable end results.
  • May work on several technical problems of moderate scope where analysis requires review of given parameters/systems and strong communication skills.
  • Exercises judgment within defined procedures and practices to determine appropriate action.
  • Adjusts and correlates clinical data, analyzes results, and recognizes and corrects system bugs.
  • Performs work using existing standards, methodologies and processes, investigates alternatives.
  • Learns new software and supports it.
  • Understands and applies procedures, practices and department standards to consistently produce error free results in a timely manner.
  • Develops project plans and ensures the dates are met.
  • Independently proposes and develops new programs to handle and analyze clinical data.
  • Identifies and implements process improvements.
  • Aware of other business processes and related disciplines and how they relate to each other.
  • Participates in projects as a Clinical programmer.
  • Makes decisions on the software and internal structure of the Clinical Database.
  • Creates database development plans and follows the plan through a series of related detailed steps to achieve the anticipated goal.
  • Completes project tasks within time and budget constraints.
  • Works under general supervision of Manager or Principal Programmer.
  • Work is reviewed for soundness of judgment and to determine if desired results have been achieved.
  • Risks associated with tasks extend to impact on a major study timeline.
  • Programming expertise is recognized by peers, Clinical group and management.
  • Directs shortterm activities performed by vendors, or less experienced peers.
  • Influences timelines of the studies.
  • Sells new processes/software solutions/programming practices to management and peers.
  • Deals regularly with other members of the Clinical group and managers within department and vendors.
  • Will represent database sub-group of DM group on projects or segments of projects.

Additional Qualifications from Legacy System

  • Bachelors degree required.  Biostatistics, statistics, information science, public health, or life science preferred.  
  • Minimum of 3 years experience in clinical research and database programming; prefer at least 1 year in device or pharmaceutical clinical trials as a clinical programmer performing mentioned above functions using SAS, Oracle Clinical or Clintrial and/orACCESS  
  • Experience building at least one major clinical database
  • Coordinates and monitors activities/projects  Able to set up, clearly communicate and follow project plans  
  • Participated in SOP, WI and other guidelines design  Provides technical support to all the members of the team  
  • Actively participates in activities (teamwork). and makes valued contribution to multidisciplinary team projects.  
  • Shares resources, knowledge and accountability, leads others  
  • Must have experience in using SAS, word processor applications, spreadsheets and databases.  
  • Must be accurate and organised in work approach and have good attention to detail in order to ensure that the programs developed meet requirements and are fit for purpose.  
  • Must have good oral communication skills to be able to provide management and staff with feedback on performance and development needs and report and present progress to Senior Management.  
  • Must have good written communication skills to be able to prepare appropriate reports, interpret results and prepare effective summaries relative to the implications of those results.

Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.

In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact hr@horizontal.com.

All applicants applying must be legally authorized to work in the country of employment.

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