Clinical Data Programming Lead
Accellacare
Chennai,Bangalore Urban,Thiruvananthapuram
5d ago

Job Description :

Participate in study specific database setup with at least one CDMS system.

Review database specification documents created by study teams for specific EDC systems.

Oversee study build activities and respond to any issues immediately to not affect the study timelines.

Review specifications, timelines, requirement and work with CDMS team to build study as per clinical protocols.

Act as subject matter expert for any study related technical questions.

Liaise with EDC product support for trouble shooting any issue identified during study build and resolving it in quick turnaround time.

Ensuring smooth flow of studies from start until database lock / freeze / decommission.

Work closely with CDMS programming & Validation Group to ensure all programming issues are resolved in a timely manner and study timelines are met.

Exhibit strong co-ordination and communication skills across teams.

Attend sponsor audits and assist with in-progress audits.

To participate and contribute to internal user group meetings, Process improvement sessions, to share knowledge and provide latest updates / features.

Participate in Data Management department initiatives.

Ensure all queries all responded to in a timely manner.

Ensure that queries that could not be resolved are routed to the correct SME and the issue is pursued until resolved.

Contribute to training materials on a process, system or technology level.

Works with ICON University and DM management on delivery of training courses, instructor-led and on-the-job training.

Ensure programming processes are compliant with applicable SOPs.

Create and maintain study documentation as required, in accordance with ICON SOPs.

Adhere to Data Management department quality control procedures.

Liaise with other ICON functions and sponsors as needed.

To undertake other reasonably related duties as may be assigned with from time to time.

Manage multiple projects across multiple EDC systems, sponsors and ensuring that timelines are met and deliverables are of high quality.

Presentations and attendance at appropriate scientific meetings and conferences.

Requirements :

Any Graduate with 6 - 7 years of relevant experience

Experience in Veeva EDC is mandatory

Benefits of Working in ICON :

Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors.

Our annual bonuses reflect delivery of performance goals - both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment.

All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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