Clinical Data Manager I

 

Clinical Data Manager I

Company:- Quanticate

Bengaluru, Karnataka, India (On-site)

Full-time:- Mid-Senior level

Job Description

• Our team is growing and we are very excited! An exciting opportunity has arisen for a Clinical Data Manager I has become available within our Clinical Research Organization.

Responsibilities:

• To lead, co-ordinate and action all tasks relating to Clinical Data Management from the start to the finish of a study.
• To project manage studies across DM functions.
• Project management for allocated projects.
• To help plan and manage study timelines and resources.
• To manage progress against schedules and report to management.
• To perform project management across all functions for a study as appropriate.
• Management of CRFs and all related tasks.
• To contribute to the efficient running of the Clinical Data Management department as part of the Clinical Data Management leadership team.
• To pro-actively keep abreast of current data management developments and systems.
• To mentor data management staff.
•  To assist in the creation and review of in-house SOPs.
• To research and provide input into in-house strategies and systems.
• Ensure launch, delivery, and completion of all Data Management procedures according to contractual agreement and relevant SOPs, guidelines and regulations.· 
• Be willing to travel both domestically and internationally as necessary. 
• To undertake other ad hoc tasks as required. 

Person specification/Qualifications:

• Degree level in a life sciences subject or equivalent and 4-7 Years of experience.
• PC skills, including some knowledge of Excel and Word.
• Excellent organizational skills and analytical skills and attention to detail.
• Good communication skills (oral and written) and good analytical skills.
• Thorough knowledge of ICH Guidelines and GCP including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.
• Ability to manage competing priorities in a changeable environment.
• Ability to inspire effective teamwork and motivate staff.
• Ability to effectively lead project teams across multiple locations.
• Excellent project management skills.
• Extensive knowledge of at least 2 Clinical Data Management systems:

Oracle Clinical

Medidata Rave

Inform

About the company:

Quanticate is a leading global data-focused Clinical Research Organization (CRO) which may also be known as a 'Biometric CRO'. Quanticate has a global reach with offices across 3 continents and is primarily focused on the management, analysis and reporting of data from clinical trials and post-marketing surveillance.

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