Clinical Data Manager

2 Months ago • All levels • Data Analyst • Undisclosed

About the job

2 skills required for this role

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quality-control

cross-functional

Job Description

As a Clinical Data Manager (CDM), you will be responsible for overseeing the data management activities for clinical trials in accordance with regulatory requirements, industry best practices, and company standards. You will collaborate with cross-functional teams to ensure the integrity, accuracy, and quality of clinical trial data, ultimately supporting the generation of high-quality, submission-ready data. Key Responsibilities: Develop and maintain data management plans and data validation specifications in compliance with regulatory guidelines and internal standards. Oversee the collection, cleaning, and validation of clinical trial data from various sources, including electronic data capture (EDC) systems and other relevant platforms. Lead the design and implementation of data validation and quality control processes to ensure data accuracy and integrity. Collaborate with clinical, statistical, and programming teams to support database lock activities and generate final analysis datasets for regulatory submissions. Contribute to the development and review of clinical study protocols, case report forms (CRFs), and other relevant documents. Participate in the selection and oversight of external vendors and CROs related to data management activities, ensuring quality and timeliness of deliverables. Stay abreast of emerging trends, technologies, and industry standards related to clinical data management and propose relevant process improvements.

Must have:

Develop data management plans
Oversee data collection and validation
Lead data validation and quality control
Collaborate with cross-functional teams
Contribute to protocol and CRF review

Good to have:

Knowledge of Sample tracking processes

Description

Job Description:
As a Clinical Data Manager (CDM), you will be responsible for overseeing the data management activities for clinical trials in accordance with regulatory requirements, industry best practices, and company standards. You will collaborate with cross-functional teams to ensure the integrity, accuracy, and quality of clinical trial data, ultimately supporting the generation of high-quality, submission-ready data.

Key Responsibilities:

Develop and maintain data management plans and data validation specifications in compliance with regulatory guidelines and internal standards.
Oversee the collection, cleaning, and validation of clinical trial data from various sources, including electronic data capture (EDC) systems and other relevant platforms.
Lead the design and implementation of data validation and quality control processes to ensure data accuracy and integrity.
Collaborate with clinical, statistical, and programming teams to support database lock activities and generate final analysis datasets for regulatory submissions.
Contribute to the development and review of clinical study protocols, case report forms (CRFs), and other relevant documents.
Participate in the selection and oversight of external vendors and CROs related to data management activities, ensuring quality and timeliness of deliverables.
Stay abreast of emerging trends, technologies, and industry standards related to clinical data management and propose relevant process improvements.
Knowledge of Sample tracking processes (Good to have)

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