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For Employers

Clinical Study Data Manager

Gratitude India Manpower Consultants Pvt. Ltd.

5 - 10 years

|

3 - 7 Lacs

Posted:17 hours ago| Platform:

Apply

Skills Required

data management oracle sql protocols statistics clinical operations fda pharmaceutical quality control medidata rave ich-gcp guidelines drug safety clinical data management pharmacovigilance cdm gcp clinical research oracle clinical ich-gcp meddra

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibility

Manage and oversee the collection, review, and reporting of clinical trial data.
Ensure compliance with regulatory requirements, such as GCP and FDA guidelines.
Develop and implement effective data management plans and procedures.
Collaborate with cross-functional teams, including clinical operations and statistical analysis.
Conduct quality control checks on data accuracy and completeness.
Provide training and support to site staff on data management best practices.

Job Requirements

Strong knowledge of clinical study protocols, informed consent forms, and case report forms.
Experience with data management systems, such as Oracle or SQL.
Excellent analytical and problem-solving skills, with attention to detail.
Strong communication and interpersonal skills, with the ability to work effectively with stakeholders.
Ability to prioritize tasks and manage multiple projects simultaneously.
Familiarity with ICH-GCP guidelines and other relevant regulations.

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