To us it’s personal.

Senior Clinical Application Programmer

Covance 5/16/2019 5:49:23 AM
JOB ID: 31232 Category: Biostatistics Programming
Bangalore, India



Job Overview

* Serve as the technical leader and actively contribute to ACIS strategy and vision
* Mentor and aide in staff development, and achievement of competency standards
* Oversees allocated staff for operational and infrastructure activities
* Manage project finances within the scope of assigned budgets.

* Leads 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
* Designs novel solutions to improve ACIS infrastructure
* Provide technical expertise and advice to Data Management to maximize EDC efficiency
* Support technical services staff in achieving internal and external client satisfaction through delivery of quality deliverables, on-time and on-budget.

* Leads 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 advice and support to business development for time and cost estimates and prepare and present to potential clients on global technical support capabilities.
* Provide support and trouble-shooting of EDC systems, and act as the Biometrics liaison.
* Assist with technical planning for multi-protocol projects.

* Complete assigned work utilizing current EDC technologies or other proprietary software according to Covance SOPs, Work Instructions, and project specific guidelines in accordance with Good Clinical Practices.

* Meet with data manager 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 peer review procedures for database development.
* Ensure filing of study documentation is maintained to standard required according to processes and acceptable for audit.

* 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.
* Interact with the management and wider team in related disciplines to ensure consistency in approach, ongoing co-operation and teamwork and regular discussion regarding process improvements.
* Communicate on a global level and encourage teamwork on a global basis.
* Work on complex problems where analysis of situations or data requires an evaluation of intangibles variables; development of technical solutions to abstract problems which require use of ingenuity and creativity.
* Demonstrate excellent problem solving skills, a proactive approach and a willingness to make decisions on a regular basis and communicate these clearly.
* Take an overview of difficult projects, providing advice and consultation to ensure timely and efficient completion of these projects. Ensure all issues raised are addressed and all potential issues are handled proactively.

* 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.

* 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.


* 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


* Minimum 9.5 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

* Demonstrated ability to work in a team environment

* Demonstrated ability to handle multiple competing priorities

* Proven managerial and interpersonal skills.

Position Type: Full-Time

Location: Bangalore, IND - India


Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).