Covance Senior Clinical Application Programmer in Princeton, New Jersey

Job Overview

Mentorand aide in staff development, and achievement of competency standards

  • Assist in the development and implementation of solutions to global technical service issues and concerns regarding Medidata RAVE, and Oracle Inform,or other proprietary software, including proactive prevention strategies

  • Assist in development of global technical services competency models

  • Assist with the development of training programs to ensure staff, project and technical, achievement of position competencies. Present training programs to the technical staff regarding study build, change control and/or CRF Design.

  • Participate in the development of global, harmonized SOPs and specific quality work instruction for technical service group activities

  • Maintain technical competency through participation in internal and external professional seminars and participation in professional organizations.

  • Provide support and trouble-shooting of EDC systems, and act as the Biometrics liaison.

  • Provide support to data management for time and cost estimates and prepare and present to potential clients on global technical support capabilities.

  • Complete assigned work utilizing Medidata RAVE or Oracle InForm or other proprietary software according to Covance SOPs, Work Instructions ,and project specific guidelines in accordance with Good Clinical Practices

  • Meet with data manager on assigned projects to discuss technical strategies, contractual obligations and timelines. Escalate resource needs as appropriate.

  • Provide leadership and consultation in the area of database design and development with data managers.

  • Review draft and final annotated data capture instruments and Physical Data Models for projects to ensure quality and consistency. Perform quality control procedures for database development.

  • Participate in the ongoing review of the processes used by the Technical Services Group to ensure adaptation of best practices.

  • Assist management with evaluation of new technologies as assigned.

  • Prioritize personal workload to meet specified completion dates and perform work without direction.

  • Conduct Peer Review/ Quality Control of study design for assigned projects.

  • Load standard client specific dictionaries in development area

  • Create, review and maintain objects in TMS Standard Domain.

  • Review and approve derivation and edit checks requested by the project teams. Discuss alternative programming for procedures, if appropriate.

  • Program, test, and maintain derivation and edit check procedures in the EDC environments.

  • Assist in developing and maintaining data loading procedures.

  • Provide input into assessments of resource requirements on a regular basis. Provide feedback to management if any action is needed to increase utilization, improve efficiency or amend the resource levels required on a project.

  • Participate in the evaluation and validation of new or updates to EDC software.

  • Ensure integration of Imaging development with OC studies

  • Provide expert technical guidance to project teams, external clients and internal clients within a global setting.

  • Prepare and provide internal training on advanced topics as needed in conjunction with senior management.

  • Advise management of changes in scope of projects to enable the timely development of change orders.

  • Implement processes as they are refined or as new processes are developed and initiate and participate in the ongoing review of the processes to ensure they are continually improved.

  • Provide feedback to management on the development potential of staff to assist in staff development.

  • Assist with interviewing and selection of potential candidates utilizing the DDI selection process.

  • Maintain awareness of new developments in EDC products which may be applied to improve the efficient use of these systems.

  • Perform all work with knowledge of regulations pertaining to computerized systems to projects to ensure compliance.

  • Perform other duties as assigned.

Education/Qualifications

  • University/college degree (life science, computer science, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer science, medical or laboratory technology)

  • Broad knowledge of drug development process

  • Basic knowledge of budgets and relationship to productivity targets

  • Thorough knowledge of the Oracle Clinical Data Management System to ensure the efficient integration and adaptation of imaging and remote data capture tools

  • Working knowledge of medical coding dictionaries and their application

  • Knowledge of time and cost estimate development and pricing strategies

  • Working Knowledge of System Validation Life Cycle in relationship to the implementation new applications

  • Fluent in English, both written and verbal

Experience

  • Minimum eight years of relevant work experience to include data management, database support and dictionary support activities including five years Medidata RAVE, Oracle Inform, or equivalent experience

  • Demonstrate excellent problem solving skills, a proactive approach and the ability to make sound decisions.

  • Demonstrated skill in leading teams, by example and mentoring staff

  • Demonstrate excellent problem solving skills, a proactive approach and a willingness to make decisions on a regular basis and communicate these clearly.

  • Excellent oral and written communication and presentation skills

  • Knowledge of clinical trial process and data management, biometrics, and systems applications to support operations

  • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies

Job Number 2018-18950

Job Category Other

Position Type Full-Time

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.