Covance Senior Clinical Applications Programmer in Bangalore, India

Job Overview

Work Location: Bangalore

Technical Leadership with responsibility for delivering technical EDC services and management of data streams of vendor data within the scope of assigned projects to achieve project integrity and the delivery on-time, quality data.

Act as a liaison with project team members, and Data Managers to drive the technical aspects of project delivery.

Essential Job Duties:

  • Mentor and 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 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 troubleshooting 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 utilization 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.

  • Participation 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 conjuction 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 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.

Top 3 reasons you should join us:

  1. Energizing purpose: Our work improves lives. Covance has helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today. You will personally contribute every day to advancing healthcare.

  2. Exceptional people: You will join a growing team of people who have a common goal for exceptional service and quality. You will learn from the most talented minds and subject matter experts, in an agile, supportive, and caring environment.

  3. Extraordinary potential: You will work in a most stimulating and a flexible work environment that will help you thrive personally and professionally.

Get to know Covance

Covance, a $15 billion Fortune 500 company, with operations in over 97 countries, has led the way in improving patient outcomes through visionary data sciences over the last five decades. We have supported 100% of the top 50 drugs in the market and all the oncology medicines approved in 2016. Our team of over 57,000 across the globe is committed to advancing healthcare and bringing new medicines to market sooner. Our unique perspectives, built from decades of scientific expertise and precision delivery, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Driven by a passion for excellence and a relentless commitment to quality, we unlock opportunities that advance innovation and deliver the promise of a healthier world. Together, with our large pharmaceutical and emerging biotech clients, Covance transforms today's health care challenges into tomorrow's solutions.

Over the years we have been recognised and applauded for our efforts in the creation of personalised medicines and innovative therapies to deliver on the promise of a healthier world. Some of our recent accolades:

  • LabCorp named in FORTUNE Magazine's 2018 list of ‘World’s Most Admired Companies”

  • Frost & Sullivan Best Practice Award – Asia Pacific CRO Growth Excellence Leadership Award

  • IMDiversity – Corporate Diversity Honor Roll

  • Flexjobs – Top 100 Remote Work – Company to Watch

  • Life Science Strategy Group – Rated as the CRO “Making the right moves to be successful in the future”

Tolearn more about our exciting opportunities in India, visit

Education/Qualifications

Education :

Graduate or Bachelor’s degree in Life Sciences (or Pharma or related health discipline) from an accredited university or college.

Experience

Minimum Required

  • Minimum eight years of work experience to include data management, database support and dictionary support activities including five year Medidata TAVE, Oracle Inform and 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 and 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

Job Number 2018-17991

Job Category Clinical Operations

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.