Latest Jobs at PAREXEL

Summary:

• The Clinical Database Programmer is responsible for the programming of high-quality clinical databases. Responsible for supporting assigned segments of the client’s portfolio. Accountabilities to include the design, development, and maintenance of clinical databases, ensuring the integrity of clinical data, application of standards supporting consistency in asset/submission data.

Responsibilities:

• Works closely with department roles and cross-functional study team members to create data capture solutions that support the quality and timely delivery of data required per standard and study specific data review plans.
• Complies with applicable SOPs and work practices.
• Learn client’s database technologies.
• Develops knowledge of data capture tools and methods that support the accuracy and integrity of study data.

Qualifications:

• Bachelor's degree in Life Science, Computer Science or equivalent.
• Minimum of 1+ years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions.
• Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills.
• Technical skills and experience using relational databases (e.g. Oracle InForm, Oracle DMW, MS SQL Server or MS Access).
• Strong communication (written and oral), decision-making, influencing, negotiation, and project management skills.
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.).
• Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g. data review, study reports, regulatory submissions, safety updates, etc.).
• Understanding regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable.

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Summary:

• The Senior Clinical Database Programmer is responsible for the programming of high-quality clinical database and for the provision of expertise in clinical database technology. Responsible for supporting assigned segments of client’s portfolio. Accountabilities to include the design, development, and maintenance of clinical databases, ensuring the integrity of clinical data, application of standards supporting consistency in asset/submission data. The Clinical Senior Database Analyst mentors junior staff in database technologies and client’s standard database conventions. Serves as a subject matter expert on the design of eCRFs and clinical databases across one or more therapeutic areas.

Responsibilities:

• Works closely with department roles and cross-functional study team members to create data capture solutions that support the quality and timely delivery of data required per standard and study specific data review plans.
• Complies with applicable SOPs and work practices.
• Serves as subject matter expert in one or more technologies.
• Leads and contributes to cross-functional technical initiatives in collaboration with clients Digital and other teams.
• Supports knowledge development of data capture tools and methods that support the accuracy and integrity of study data.

Qualifications:

• Bachelor's degree in Life Science, Computer Science or equivalent.
• Minimum of 5 years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions.
• Technical skills and experience using relational databases (e.g. Oracle InForm, Oracle DMW, MS SQL Server or MS Access).
• Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills.
• Strong communication (written and oral), decision-making, influencing, negotiation, and project management skills.
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.).
• Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g. data review, study reports, regulatory submissions, safety updates, etc.).
• Understanding regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable.

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• The Clinical Programmer will be responsible for the provision of data review and trial management deliverables across all compounds and trials for which these are required, and for all functional groups that require those deliverables.
• Working as a Clinical Programmer at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.

Essential Knowledge and Experience Required for this role:

• Minimum of five years of experience in developing software in a clinical trial environment using SQL, including at least three years of clinical programming experience. 
• Experience with data reporting tools in a clinical trial setting. 
• Experience in the Biotechnology, Pharmaceutical, or Life Sciences industries (Clinical Research Organization - CRO or Clinical Trial regulated environment preferred). 
• Experience with the eClinical Solutions elluminate platform an advantage. 
• Knowledge of some additional programming languages (e.g.: SAS, PL/SQL, R, Python, Java, …) a definite advantage. 
• Experience with Qlik Sense a plus. 
• Preferred additional external data transfer experience in:
• Creating external data transfer specifications, ensuring external clinical trial data are compatible with the clinical database to support data integration, analysis and reporting. 
• Experience in planning, set-up, and acquisition of external clinical data at the study level 
• Liaising with and reviewing work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.). 
• Working knowledge of Microsoft products: Outlook, Word, Excel, Teams. 
• We may have flexibility to hire at either Senior Clinical Programmer level or Junior Clinical Programmer level for this role. Junior level experience requirements include up to five years of relevant experience and Senior level positions would require five or more years of relevant Clinical Programming experience.

Skills Required:

• Skilled in programming in a relational database setting with SQL and/or T-SQL or ETL. 
• Ability to balance and prioritize multiple assignments and respond quickly to ad hoc requests. 
• Familiarity with CDISC standards, including CDASH and SDTM. 
• Excellent verbal and written communication skills. 
• Project management skills an advantage.

Education Requirements:

• Bachelor’s degree in computer science, Statistics, Mathematics, Life Sciences or other relevant scientific fields 

Overall Summary of Daily Activities for this Clinical Programmer Role involve;

Oversight of programming activities

• Program simple to complex data review listings, exception reports, QTL/KRIs, metrics reports and visualizations in a fast-paced environment for clinical trial data review and management purposes 
• Contribute to the development of software systems and related infrastructure to generate displays of clinical study data and metrics reports that are efficient and user-friendly 
• Create and document archives of software and deliverables 
• Create any Work Instructions process and training documents needed related to clinical programming and the required deliverables 
• Provide time and resource estimates for project planning as well as accurately record time spent on multiple deliverables 

Collaborative relationships

• Liaise with Clinical Data Management and/or cross functional staff to understand the needs of the end users of the listings, reports, and metrics 

Compliance with Parexel standards

• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements