Clinical Data Manager - Bangka Belitung

Join PT Medika Data Solusi, a leading healthcare data management firm in Bangka Belitung, as a Clinical Data Manager. In this pivotal role, you will ensure the accuracy, integrity, and compliance of clinical trial data, driving innovation in medical research. With a focus on data quality, security, and regulatory adherence, you'll work closely with cross-functional teams to streamline data collection, monitoring, and analysis processes. This opportunity offers significant growth potential in a dynamic and supportive environment.

As a Clinical Data Manager at PT Medika Data Solusi, you'll be responsible for overseeing the entire lifecycle of clinical trial data, from initial collection to final reporting. You'll use industry-standard tools like Oracle Clinical Data Management System (Oracle CDMS) and SAS to manage and analyze data, ensuring it meets the highest quality standards. This role is ideal for professionals with a strong background in clinical research and a passion for improving patient outcomes through data-driven insights.

📋 Tanggung Jawab Pekerjaan

• Oversee the entire lifecycle of clinical trial data, ensuring accuracy, integrity, and compliance with regulatory guidelines.
• Manage and analyze clinical trial data using Oracle CDMS and SAS, ensuring data quality and consistency.
• Develop and implement data management plans, including data collection protocols, data entry procedures, and data validation checks.
• Monitor data quality metrics and implement corrective actions to address any issues.
• Collaborate with cross-functional teams, including clinical research associates, data coordinators, and regulatory affairs, to ensure seamless data management processes.
• Conduct regular audits and reviews of clinical trial data to ensure compliance with regulatory requirements.
• Provide training and support to data management teams, ensuring they have the necessary skills and knowledge to perform their roles effectively.
• Stay up-to-date with industry trends, best practices, and regulatory changes to ensure the continuous improvement of data management processes.

🎓 Kualifikasi & Syarat

• Bachelor's degree in Clinical Research, Biostatistics, or a related field.
• 5-7 years of experience in clinical data management, with a strong background in regulatory affairs and data quality.
• Certification in Clinical Data Management (CDISC) or a related field is highly desirable.
• Proficient in Oracle CDMS and SAS, with experience in data analysis and reporting.
• Strong understanding of regulatory requirements, including ICH-GCP and FDA guidelines.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment.
• Detail-oriented with a strong commitment to data accuracy and integrity.
• Ability to manage multiple projects and prioritize tasks effectively.

🛠️ Keahlian

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