Clinical Trial Sme

1 week ago

Bengaluru, India ICON plc Full time

**Clinical Trial SME**

**Location: Chennai or Bangalore or Trivandrum (Home based)**

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

**Summary**

The Clinical Trial Subject Matter Expert (CT SME) provides clinical expertise and advice regarding study protocols to a multi-disciplinary production team to enable the creation of various training modules for our clients. The CT SME reviews the training modules for 100% accuracy to the protocol and to ensure that it provides value to the end user.

**Responsibilities**:

- Recognize, exemplify and adhere to ICON’s values which centre around our commitment to People, Clients, and Performance.
- Accountable for determining the protocol-specific challenges for each protocol that has been assigned to the team and identify possible Firecrest solutions.
- Responsible for reporting to the Production Team at project start up to provide protocol information and background to aid in the teams understanding of the study.
- Required to provide support to the team PM at Client External Kick Off meetings.
- Responsible for supporting the team Technical Writer (TW) to produce Firecrest scripts that are 100% technically accurate for our site training modules.
- Responsible for the technical review of scripts prepared by other members of the team to ensure 100% technical accuracy to the protocol and relevance to the end user (i.e. Investigators and Site Staff).
- Takes ownership for the technical accuracy of all product graphics ensuring that they are both informative and 100% correct.
- Oversees the review of all modules prior to final release to the client to ensure that all quality standards have been met.
- Creates supporting documentation to compliment the end products to add value for the client.

**What you need?**
- Bachelor’s degree in life sciences or local equivalent.
- Prior relevant experience in the clinical trials industry, preferably 2 years of experience as a CRA.
- Familiarity in working with clinical trial protocols (and other study documents), ideally across several therapeutic indications.
- Excellent communication skills.

**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.

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