Principal Database Programmer I

3 days ago

Pune, India Aixial Group Full time

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, UK, US, Belgium, Czech Republic, Switzerland, Denmark, Romania, and India.

The CRO occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials in complex disease areas including oncology, immuno-oncology, and cell therapy, but also as a developer of its own technologies for managing clinical data. This is a very exciting time to join as we are at the cutting edge, defining new and more efficient ways to design, capture, manage, review, and visualize clinical trial data.

We are currently looking for an enthusiastic and talented Principal Database Programmer I. This role can be home-based in India or office based in Pune, India.

PURPOSE AND MAIN RESPONSIBILITIES

Purpose

The Principal Database Programmer1 is responsible for performing database programming tasks per client work orders to high regulatory standards and Aixial Group SOPs.

**Responsibilities**:
Line Management (optional)
- Manage, coach and support career development and performance of direct reports.
- Ensure direct reports have clear objectives and that they have Individual Development Plans, as required.
- Ensure direct reports have regular one-to-one meetings.
- Support regular performance appraisals of direct reports adherence to the company performance management process.
- Ensure compliance with the requirements and the company’s Quality Policy by ensuring mandatory trainings and SOPs are completed by direct reports in timely manner and collaborating effectively in the audits and inspections.

Operational Management
- Responsible for Unique development (CRF design) in EDC database, screens design and database development as per protocol
- Program edit checks as per Data Validation Specifications
- Closely work with Lead Data Manager on assigned projects
- Act as SME for Database Programming
- Responsible to maintain Global Libraries (CDASH)
- Represents Data Management at study team meeting/client meetings when needed (i.e. related to database set up)
- Participate to study documentation archiving
- Completes Aixial administrative tasks as required e.g., timesheets, CV and training updates
- May undertake other tasks as assigned by Line Manager

Leadership and Oversight
- Provide input into recruitment process as required
- Mentoring of junior staff
- Contribute to maintain SOPs

Required Skills and Qualities
- Bachelor’s degree qualification in a Scientific discipline is preferred
- 8 or more years as a Database Programmer or equivalent combination of education, training and experience
- Strong knowledge of database development
- Strong experience with Rave, Viedoc or Veeva
- Rigor and organization
- Interpersonal skills
- Oral and written communication
- Client focused
- Knowledge of the applicable regulations in her/his field (s) of activities (Cf List-REG-001)

Technical Skills
- Strong Experience with several EDC (Rave, Viedoc, Veeva)
- CDASH standard

Languages
- Fluent English: Read, Written, Spoken

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