EDC Clinical Support Analyst

Company Overview:

 

Keryx Biopharmaceuticals is a biotechnology company developing novel compounds for multiple diseases including Oncology.  Keryx works with academic and community practices to conduct Phase I, II, and III clinical trials. We are seeking a motivated, creative, and energetic individual to join our team and help develop a new approach to managing clinical trials.

 

Overview:

 

Keryx Biopharmaceuticals seeks an organized, motivated and detail-oriented EDC Clinical Support Analyst:

 

The EDC Clinical Support Analyst will be responsible for executing the data management activities in coordination with the clinical team to ensure the accurate and complete data collection using EDC and any other clinical systems that support the global external investigator site staff. The candidate will be the primary contact for incoming site communications related to EDC related problems or issues and will help establish seamless support for EDC applications. Additionally, this person will liaise with internal customers to ensure, manage, resolve, and escalate issues when necessary through resolution of key problems and will ensure that data management deliverables are maintained. 

 

Responsibilities (include, but are not limited to):

 Create, design, and test clinical databases in accordance to standard operating procedures in coordination with Data Management prior to production release to Investigative sites.

 Develop, program, verify/validate, and maintain clinical trial databases and data entry screens.

 Provide technical expertise and programming support for clinical trial projects and data management programming staff.

 Review data management plans for electronic edit/validation checks.

 Develop, program, test and maintain electronic edit/validation checks.

 Provide technical training for in house staff and investigator staff on the use of the EDC system.

 Communicate project status and key projects issues to Data Management team lead and department management.

 Communicate back to the clinical team of post-mortem investigation on previous database design for continuous improvement for new studies design.

 

Qualifications:

 Bachelors degree in life sciences, computer science, business, or related discipline.

 4 to 5 years of related work experience as a programmer, business analyst, or clinical data manager.

 Minimum 2 years of work experience with clinical systems such as SAS, CTMS, EDC, IVRS, Oracle Clinical, and/ or other related technology in the pharmaceutical/biotechnology industry.

 Familiarity with Data Management processes through formal coursework or previous experience is required.

 Ability to work independently.

 Strong attention to detail in composing materials, establishing priorities, scheduling, and meeting deadlines.

 Good interpersonal skills to manage new and ongoing relationships with sites' investigative staff.

 

If you are looking for a challenging career where you can use your unique talents to contribute to the frowth of small biotechnology, then this is the job for you.

 

Please send resume and salary requirements to jobs@keryx.com .  Please write EDC Clinical Support Analyst in the subject line of the email and include your salary requirements in the email.