Title: Clinical Programmer Consultant
Duration: 12+ months
Location: Berkeley Heights, NJ
Job Description:
Responsibilities will include •
· Develop, program, test and maintain clinical trial databases and data entry screens using Oracle Clinical or Central Designer in accordance with client's standards •
· Review computer validation/edit checks for in-house and outsourced studies •
· Develop, program, test and maintain computer validation/edit checks in PL-SQL and/or SAS •
· Develop, program, test and maintain data review listings in Oracle Clinical, Inform, J Review and/or SAS for data review purposes •
· Perform external data loads, i.e., labs, ECGs, etc., as needed.
· Act as liaison with vendors to establish transfer specifications and client's standards •
· Validate peer programming •
· Participate in and lead team meetings when appropriate •
· Act as primary CRO contact, when necessary, to ensure that client's standards are implemented in all studies •
· Provide technical expertise and support to Data Management team •
· Control access to database and perform snapshots, database lock and freeze activities •
· Make data, including interim data, available to company personnel and regulatory agencies when required •
· Perform post processing of data extracts in accordance with client's standards to be delivered to Biostatistics •
· Routinely interface with cross-functional team members •
· Influences other functions and represents as DBO technical expertise •
· Internal team leader who decides best course of action •
· Coach and advise junior programmers to identify problems and solutions
· Manage outside CROs and consultants: •
· Review clinical programming activities and costs in contracts •
· Assess CRO data management systems for regulatory compliance •
· Interact with CROs in the design and development of databases that are compatible with company needs •
· Monitor progress of clinical programming activities in CROs •
· Participate in regular team meetings and provide input when appropriate
· Participate in the development of clinical programming SOPs and the development/optimization of clinical programming processes from study start up to database lock. •
· Routine interface with cross-functional team members in creating an appropriate database, data quality assurance, and support of data cleaning activities •
· Direct responsibility for supervising and training junior clinical programmers in the performance of their duties •
· Managing project priorities and timelines
Skills/Knowledge Required: •
· BS/BA degree or equivalent in a relevant scientific discipline
· Minimum of five years of experience •
· Expertise in all facets of EDC setup, UAT (in particular RAVE) a must
· Advanced knowledge of clinical database design is a must (Inform, Oracle Clinical or other systems). •
· Experience managing clinical programmers •
· Participation in at least one NDA (new drug application) is preferred •
· Good communication skills; ability to work in a team environment with data managers, medical personnel, clinical monitors, statisticians, programmers, and medical writers •
· Knowledge of FDA/ICH guidelines and industry standard practices regarding programming •
· Detailed knowledge and experience in case report form design, central laboratories, programming databases, query resolution, data validation •
· Knowledge of SQL and SAS programming •
Computer skills:
· Detailed knowledge of clinical database design (Oracle Clinical or Inform), proficiency with SAS data sets and conversion procedures, knowledge of MS Office program suite •
· Knowledge of clinical trial design and basic statistics (a plus)
· Medical or mathematics/computer science background a plus
Thanks & Regards
Kevin Brooks
Amtex System Inc.
50 Broad Street, Suite 801
New York, NY-10004
Cell: 917-463-4086
GTalk: amtex.kevinb
E-mail: kevinb@amtexsystems.com
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