Senior Clinical Programmer
4 weeks ago
About thejob
At Cytel we work hard tocreate successful careers with significant professional growth forour employees as a result of which they work hard to make Cytelsuccessful. Cytel is a place where talent experience and integritycome together to advance the state of clinicaldevelopment.
Senior Clinical Programmer(Quality/Technical Review) role is responsible for contributing tothe assessment and tracking of the quality of programming tasks andactivities executed by CRO and FSP vendors performing clinicaltrial programming work. The position collaborates with theBIOMETRICS staff management and vendor clinical programmers toschedule and conduct the review of study documentation andprogramming quality related to the design and testing of electronicdata capture systems including eCOA and EDC databases to ensurethat all clinical trial databases and electronic collection toolsare consistent with the needs of the study protocol and departmentstandards and procedures. He/She collaborates closely withBIOMETRICS Data and Analytics Leads to plan timelines and workloadto ensure deliverables are met across the client portfolio. He/Sheperforms additional clinical programming tasks including but notlimited to data loading and reportcreation.
Summary Of JobResponsibilities
- Conducts technical review and QC of clinical programmingdeliverables from internal and vendoremployees.
- Provides analysis and trending ofquality to management feedback and training to internal and vendoremployees as needed.
- Performs additionalclinical programming tasks including but not limited to dataloading and report creation. Works with the requestor to definerequirements and performs QCs programming.
- Ifrequired reviews or creates user acceptance test scripts forquality and completeness.
- Performs UAT processto ensure highquality results feedback and compliance with industryand client bestpractices.
MinimumExperienceRequirements
- Minimum of5 to 8 years of Clinical Data Management or database/statisticalprogramming experience working in the biotechnology orpharmaceutical industry; work with CROs is highlydesirable.
- Technical/Software Skills: Expertisewith Oracle Clinical/Medidata RAVE/Inform/eCOA and/or otherclinical data management software; Expertise with Business Objectsor Elluminate reporting tool is preferred; Expertise in SQL;detailed understanding of Oracle Clinical database structures. MSOffice Visio familiarity with medical coding dictionariesespecially MedDRA and WHODrug.
- Experienceapplying best practices in clinical data management ordatabase/statistical programming in the clinical trial environmentincluding requirements definition and QCplans.
- Knowledge of GCP and otherregulations.
- Experience working in anElluminate reporting tool is preferable.
- Internal customer management influence of peers team effectivenessand enhancement timeline management proactive problemsolvingability ability to develop trust shared goals andvalues.
- Collaborative with negotiation skillsconceptual thinking systems process thinking accountability todeliverables milestones and conflict resolution (internal andexternal).
- Must have excellent oral andwritten communication/presentation/negotiationskills.
- Detailoriented able to identify issuesand consistently collaborate to solve problems in a timelymanner.
- Ability to handle multiple (changing)priorities under tighttimelines.
MinimumEducation Requirements
Bacheloror Master in Life Sciences Clinical Data Management ComputerScience Medical Informatics or equivalentdegree.
Please use the below linkfor job application and quickerresponse.
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