Clinical Data Coordinator (India)

Description

The Clinical Data Coordinator will participate in various clinical data management activities required to ensure that data captured in clinical trials undertaken, or managed by Indero, are collected, managed and reported clearly, accurately and securely. In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Indero standard operating procedures (SOPs) while respecting Indero’s commitment to sponsor’s requirements and timelines.

This role will be perfect for you if:  

• You have strong analytical capacities and an ease to work with data.
• You enjoy working with systems and technology, continuously learning.
• You want to work in a collaborative team where your ideas are heard and valued.

RESPONSIBILITIES 

-Provides general data management support to the project team, sponsor and external vendors, as needed.

-Supports Lead Data Manager in the areas of:

• Data Review.
• Data Reconciliation.
• Discrepancy Management.
• Maintenance of Study Metrics; Monitoring study status (e.g. enrollment, CRFs monitored/approved, etc.) on an ongoing basis and provide data status reports to the project team, as needed.
• Generation of Ad-Hoc Study Reports.
• User Maintenance.
• Assisting with User Acceptance Testing.
• Assisting with designing of database.
• Assisting with creating data management plan (DMP), and other clinical data management related documentation.
• Assisting in ensuring that data management documentation is complete and up-to-date in the trial master file (TMF).

Requirements

IDEAL PROFILE 

Education 

• B.Sc. or related field;

Experience  

• 1 year of clinical data management experience in the pharmaceutical industry or in a CRO environment is considered an asset;
• Experience using an EDC system (ie. Medidata Rave, Medrio) is considered an important asset.

Knowledge and skills 

• Skilled in use of computer technology, and ability to learn new applications;

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  A general knowledge of CDASH/SDTM is considered an asset
• Highly organized and detail-oriented with effective project planning and time management skills;
• Strong verbal and written communication skills in English, French is an asset;
• Ability to work in a fast-paced environment with demonstrated agility to juggle and prioritize multiple competing demands;
• Excellent interpersonal, communication, problem solving and organizational skills with the ability to work both independently and in a team environment.
• Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

Our company

The work environment 

 At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 

In this position, you will be eligible for the following perks: 

• Flexible work schedule 
• Permanent full-time position 
• Company benefits package
• Ongoing learning and development 

About Indero  

Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. 

Indero only accepts applicants who can legally work in India.