Clinical Programmer I

Avance Clinical

On-site · Full-time

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Clinical Programmer I

Avance Clinical

India

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Clinical Programmer I

Avance Clinical

India

2 hours ago

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We’re seeking an experienced Clinical Programmer I - you can work from our beautiful office in Bangalore.

Who are we?

We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field.

Why should you join Avance Clinical?

We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.

We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.

The role

Clinical Programmer I is responsible for creating study database, Case Report Form (CRF), programming of edit checks and SAS export program in accordance with the protocol; company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements.

Core Responsibilities Include

Design databases and ensure they meet the requirements for data entry as per the CRF.

Development and review of Case Report Forms (CRFs) and completion guidelines in line with the database and protocol.

Maintain effective Sponsor communication to proactively review project timelines, expectations, risks and issues.

Review of edit check document.

Programming edit checks within the database system.

SAS programming of data export and edit checks (If applicable).

May be involved in Data Management activities as required (applicable training to be documented).

Review study protocols and other study related documents.

Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.

Other duties as directed by Line Manager or delegate.

Qualifications, Skills And Experience

Bachelor’s level degree in life sciences, pharmacy, nursing or equivalent field (highly regarded), or appropriate industry experience.

Previous experience as a Clinical Programmer in a Contract Research Organisation (CRO) or Pharma company, or previous exposure to Clinical programming skills in a clinical trial related service provider.

Previous training and a working knowledge of ICH GCP and applicable regulatory requirements.

Clear understanding of the requirement to adhere strictly to client confidentiality.

Effective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information.

Demonstrated ability to take initiative in problem solving and in exercising good judgment.

An understanding of Privacy Legislation as it applies to the Clinical Trial Environment.

Ability to work under pressure in a multi-disciplinary team environment.

Willingness to work in, and be supportive of, a positive and dynamic team culture.

What We Offer

Stimulating work

Project diversity

An intellectual challenge

An agile & flexible workplace

Opportunity to progress

Stability

Sense of community

A leadership team that are working together on a common goal

Flexible work options

Great tools / tech to do your job

A competitive salary & an extra days holiday for your birthday!

At Avance difference is encouraged, its celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality.

Clinical Programming / Clinical Programmer / CRO / Pharmaceutical / India

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Seniority level

Associate

Employment type

Full-time

Industries

Biotechnology Research

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