*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.