Jobs / Science/research
Post ID: 42271
Country: United States
State: Arizona
City: Tempe
Email: maura
pinnaclesearch.net
Cape Canaveral, FL 32920
www.pinnaclesearch.net
Contact: Maura Bethon at: maura@pinnaclesearch.net
321-574-0330
Our client is located in Tempe, AZ.
Salary range is $90 - $110 with $5K relocation expense account.
Department: Data Management
Position Title: Manager, Clinical Programming
Reports to: Director, Data Management
Job Summary:
Manages clinical programming staff members providing direction to staff members regarding work tasks, priorities and job performance. Provides mentoring, coaching, and training to assigned staff members. Also, works directly as part of a project team, or possibly as a team manager/lead, to design and implement applications in support of clinical research and biostatistics. Leads the analysis, design and implementation of client-server applications such as Oracle, Clintrial, SQL and forms of GUI-based products. Develops forms, menus, data quality checks and reports based on functional and design specifications, processes and procedures, and/or client directives. Accomplishes and documents all work in full accordance with FDA regulations and guidances, and company standard operating procedures (SOPs). Actively promotes standards for the development and acquisition of systems. Participates in the evaluation and implementation of packaged systems. Communicates with the end-users. Plans for required personnel resources and works with Sr. Management to open requisitions and fill positions as required.
Primary Responsibilities:
· Develop and maintain clinical database programming standards.
· Lead in designing, developing, validating, and maintaining clinical study databases for clinical trials using Oracle Clinical software or other validated applications.
· Provide complete and accurate documentation of study databases consistent with SOPs, protocols, programming standards, and data management plans.
· Design, build and validate clinical study databases (paper and/or EDC).
· Define, implement and test data quality checks according to the data validation specifications.
· Design and/or manage SDC’s global library of standard objects (questions, question groups, DCIs, DCMs, entry screens, procedures, derivations and DVGs).
· Create and/or maintain PL/SQL standard routines/packages as applicable
· Manage and update medical coding dictionaries, including but not limited to MedDRA and WHODrug.
· Batch load external data from vendors (e.g., central lab data).
· Study Design/Protocol set up and maintenance.
· Manage user accounts for paper and EDC base studies
· Lead efforts in writing departmental documentation (e.g., training documents, processes, etc.).
· Mentor, coach, train, and motivate clinical programming staff members.
· Participate in other clinical programming and data management activities, as required.
· Staff the clinical programming group appropriately and manage related efforts.
· All other duties as assigned by management.
Required Skills:
· At least eight years of direct programming experience preferably database oriented.
· Significant experience and knowledge of Oracle Clinical database application programming.
· Demonstrated increasing responsibility throughout career with excellent leadership and management skills
· At least three years experience assuming lead responsibilities on projects in a clinical environment.
· Solid interpersonal skills and ability to work well with people at all levels of the organization.
· Demonstrated ability to provide both “user-friendly” and technical documentation.
· Ability to provide expertise to guide department in continued efficiency and growth.
· Knowledge and experience with FDA regulations and guidances (e.g., 21 CFR Part 11, ICH/GCP).
· Experience in installation and/or validation of clinical data management system (CDMS) applications in a clinical research environment is preferred.
Education or Equivalent Experience:
· Bachelors degree in computer science or other quantitative or scientific discipline with at least ten years of experience in clinical programming or equivalent combination of education and work experience.