Clinical Programmer Analyst

Alameda, California

Posted in Retail
about 1 month ago

This job has expired.

Job Info

*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*

* This field includes Main Responsibilities imported 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*

* This field includes Qualifications imported 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.

This job has expired.

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