Job Description - Associate Manager - Clinical Data Programmer

Position Title: Associate Manager - Clinical Data Programmer

Supervisor Title: Director - Clinical Operations

Position Type: Full Time

Job Function: Clinical Data Management, R&D

Location: Bangalore, Karnataka, India

Position Description:

The Associate Manager - Clinical Data Programmer provides technical expertise for the conduct of clinical trials in farm and pet animals and works independently to support various programming activities related to clinical data systems, and/or the applications within Elanco. Independent contributor role with proven ability work with virtual cross-functional global teams.

Functions, Duties, Tasks:

- Support day-to-day operations of data management projects.

- Edit checks (standard and custom) programming

- Assisting the Data manager with general data management responsibilities

- Specify, develop, and validate applications supporting data capture and processing.

- Generate and maintain all required documentation including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (CRF)s, database creation, coding setup, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports

- Work effectively and flexibly within and across all Elanco R&D teams and external collaborators to achieve overall Elanco R&D deliverables.

Minimum Qualification (education, experience and/or training, required certifications):

- Graduation or equivalent in Computer Science, Life Science, or related scientific field.

- Minimum 5 years- experience in working directly in data management.

- Working knowledge of EDC systems/capabilities and their application across veterinary regulatory standards (GXP and non-GXP)

- Experience in SAS programming.

- Experience of working with Medrio is desirable.

Additional Preferences:

- Clinical trial experience

- Advanced knowledge of electronic data capture systems

- Experience interacting with third party organizations.

- Experience with managing data for regulatory submissions

- Ability to solve complex problems.

- Ability to communicate logically and technically.

- Organizational planning skills, ability to manage competing priorities and flexibility to change.

- Commitment to quality.

- Ability to work independently or as part of a team.

- High competency in Microsoft Office.

- Ability to work additional hours as required and work with staff in irregular time zones.

- Ability to learn new systems and functions in an evolving technical environment.

Other Information:

- You will be part of the Global Operations team.

- You will work with groups in the USA, Australia, and EU region.

- You will manage Elanco operational requirements locally and ensure implementation of policies and procedures.

- You will be required to indirectly manage stakeholders that are on global scientific teams.

- You will be part of project teams as required.

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