Veterans Jobs

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

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