12 Clinical Informatics jobs in Indonesia
Remote Clinical Data Manager
Posted 7 days ago
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Job Description
Responsibilities:
- Develop, implement, and manage data management plans (DMPs) for clinical trials.
- Oversee the design, development, and testing of Electronic Data Capture (EDC) systems and databases.
- Establish data entry guidelines and procedures, ensuring consistent data collection across all sites.
- Perform data review and query management to identify, document, and resolve data discrepancies in a timely manner.
- Ensure all clinical trial data is accurate, complete, and meets quality standards prior to database lock.
- Collaborate with statisticians, programmers, clinical research associates (CRAs), and other study personnel to ensure alignment on data management activities.
- Contribute to the development and maintenance of Standard Operating Procedures (SOPs) for data management.
- Participate in study team meetings, providing expertise on data management aspects.
- Ensure compliance with all applicable regulatory requirements, including ICH-GCP guidelines and data privacy regulations.
- Manage external data integrations and data transfers as required.
- Prepare data management reports and metrics for internal stakeholders and regulatory submissions.
- Bachelor's degree in a relevant scientific or healthcare field; advanced degree preferred.
- Minimum of 4 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
- Proven experience with EDC systems (e.g., Medidata Rave, Oracle Clinical, Inform).
- Strong understanding of clinical trial processes, data management principles, and regulatory guidelines (ICH-GCP).
- Excellent data review and problem-solving skills.
- Proficiency in database management and SQL is a plus.
- Exceptional organizational skills and attention to detail.
- Strong written and verbal communication skills, with the ability to effectively communicate with diverse teams.
- Ability to work independently and manage multiple priorities in a remote setting.
- Experience with clinical trial startup, execution, and closeout phases.
Remote Clinical Data Manager
Posted 8 days ago
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Job Description
Key duties include:
- Developing and maintaining clinical databases and edit specifications in accordance with study protocols and regulatory requirements.
- Designing, developing, and validating data collection tools and eCRFs.
- Implementing data validation checks and performing ongoing data review to ensure data quality.
- Managing and resolving data discrepancies through effective query generation and tracking.
- Performing data cleaning activities and ensuring timely database lock.
- Ensuring compliance with GCP, FDA regulations, and other relevant industry guidelines.
- Participating in the development and review of Data Management Plans (DMPs).
- Generating data management reports and status updates for project teams and stakeholders.
- Contributing to process improvements and the development of standard operating procedures (SOPs) within the data management group.
- Mentoring and providing guidance to junior data management personnel as needed.
The ideal candidate will hold a Bachelor's degree in a life science, computer science, or related field, with a minimum of 4 years of experience in clinical data management within the pharmaceutical or biotech industry. Proven experience with EDC systems (e.g., Medidata Rave, Oracle Clinical) and a strong understanding of CDISC standards are essential. Excellent analytical skills, attention to detail, and strong communication and interpersonal abilities are crucial for this role. The ability to work independently and manage priorities effectively in a remote setting is paramount. This is a unique opportunity to join a forward-thinking organization and make a significant contribution to advancing healthcare, with the flexibility of a fully remote work arrangement. We offer a competitive compensation package and opportunities for professional growth.
Remote Clinical Data Manager
Posted 8 days ago
Job Viewed
Job Description
Responsibilities:
- Oversee the design, development, and implementation of clinical databases, including Case Report Forms (CRFs) and data validation plans.
- Manage data collection, query resolution, and data cleaning activities to ensure data accuracy and completeness.
- Develop and maintain data management plans (DMPs) and standard operating procedures (SOPs) for clinical data management.
- Perform data validation checks and implement data quality control measures throughout the study lifecycle.
- Collaborate closely with clinical research associates (CRAs), investigators, biostatisticians, and programming teams to ensure timely and accurate data delivery.
- Generate data management reports, including status updates, query metrics, and database lock timelines.
- Ensure compliance with Good Clinical Practice (GCP) guidelines, relevant regulatory requirements (e.g., FDA, EMA, BPOM), and company policies.
- Participate in the selection and implementation of clinical data management software and tools.
- Provide training and support to site personnel and study team members on data management processes and systems.
- Contribute to the continuous improvement of data management processes and systems.
- Effectively manage multiple projects simultaneously, ensuring adherence to study timelines and milestones.
- Bachelor's degree in a scientific, healthcare, or related field. A Master's degree is a plus.
- Minimum of 3-5 years of direct experience in clinical data management in the pharmaceutical or biotechnology industry.
- Proven experience with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical, Veeva).
- Thorough understanding of clinical trial phases, study designs, and data flow.
- Knowledge of ICH-GCP guidelines and regulatory requirements related to clinical data.
- Proficiency in database design, data validation, and query management.
- Excellent organizational and problem-solving skills, with a keen eye for detail.
- Strong communication and interpersonal skills, with the ability to work effectively in a remote team environment.
- Ability to manage time effectively and meet deadlines in a fast-paced setting.
- Experience with data standards such as CDISC (SDTM, ADaM) is highly desirable.
Remote Clinical Data Scientist
Posted 8 days ago
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Job Description
Responsibilities:
- Analyze large-scale clinical trial datasets to identify trends, patterns, and insights.
- Develop and implement statistical models and machine learning algorithms for clinical data.
- Design data collection protocols and ensure data integrity throughout trials.
- Evaluate drug efficacy, safety, and pharmacokinetics using advanced analytical techniques.
- Collaborate virtually with cross-functional teams to interpret results and inform strategy.
- Generate reports, visualizations, and presentations for internal and external stakeholders.
- Contribute to the design of clinical trials and data analysis plans.
- Stay updated on regulatory guidelines and industry best practices for clinical data.
- Identify opportunities for process improvement in data management and analysis.
- Communicate complex findings clearly and concisely to non-technical audiences.
- Master's or Ph.D. in Biostatistics, Data Science, Bioinformatics, or a related quantitative field.
- Proven experience in clinical data analysis within the pharmaceutical or biotech industry.
- Expertise in statistical modeling, machine learning, and data mining techniques.
- Proficiency in programming languages such as R, Python, or SAS.
- Experience with clinical data management systems and databases.
- Strong understanding of drug development processes and regulatory requirements.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional ability to work independently and manage time effectively in a remote setting.
- Strong written and verbal communication skills for virtual collaboration.
- Experience with data visualization tools (e.g., Tableau, Power BI).
Lead Clinical Data Scientist
Posted 8 days ago
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Job Description
Lead Clinical Data Scientist - Remote
Posted 7 days ago
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Job Description
Responsibilities:
- Lead the design and execution of data science initiatives for clinical trials.
- Develop and implement advanced statistical and machine learning models for clinical data analysis.
- Interpret complex clinical trial data to identify trends, patterns, and key insights.
- Collaborate with cross-functional teams (clinical, biostats, medical affairs) to define analytical strategies.
- Ensure data quality, integrity, and adherence to regulatory standards.
- Develop data visualization dashboards and reports to communicate findings effectively.
- Mentor and guide junior data scientists and analysts.
- Contribute to the development of data management plans and SOPs.
- Stay current with the latest advancements in data science, AI/ML, and pharmaceutical R&D.
- Present findings and recommendations to senior management and external stakeholders.
- Ph.D. or Master's degree in Biostatistics, Data Science, Statistics, Computer Science, or a related quantitative field.
- Minimum of 7 years of experience in data science within the pharmaceutical or biotechnology industry.
- Proven experience with clinical trial data analysis and interpretation.
- Expertise in Python or R, including relevant libraries for statistical analysis and machine learning.
- Strong knowledge of SQL and experience with database management.
- Familiarity with clinical trial regulatory requirements and data standards (e.g., CDISC).
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional communication and presentation skills, with the ability to explain complex concepts clearly.
- Demonstrated leadership experience and ability to manage remote teams.
- Experience with cloud platforms (AWS, Azure, GCP) is a plus.
Remote Senior Clinical Data Manager
Posted 8 days ago
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Job Description
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Senior Clinical Data Scientist - Remote
Posted 8 days ago
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Job Description
Responsibilities:
- Design, develop, and implement statistical and machine learning models for analyzing clinical trial data.
- Identify patterns, trends, and insights within large, complex datasets to support drug development and clinical research objectives.
- Collaborate closely with clinical operations, biostatistics, and data management teams to define data analysis requirements and ensure data integrity.
- Develop and maintain robust analytical pipelines and reproducible research workflows.
- Visualize and communicate complex analytical findings to both technical and non-technical stakeholders through clear reports and presentations.
- Stay abreast of the latest advancements in data science, machine learning, statistical methodologies, and their applications in the pharmaceutical industry.
- Contribute to the development and implementation of data governance policies and best practices.
- Mentor junior data scientists and contribute to the overall growth of the data science function.
- Evaluate and recommend new tools, technologies, and methodologies to enhance analytical capabilities.
- Ensure all analytical activities comply with regulatory requirements (e.g., FDA, EMA) and industry standards.
- Participate in the design of clinical trials, providing input on data collection strategies and analysis plans.
- Develop predictive models for patient stratification, treatment response, and outcome prediction.
- Contribute to the writing of clinical study reports and regulatory submission documents.
- Ph.D. or Master's degree in Statistics, Data Science, Computer Science, Bioinformatics, Biostatistics, or a related quantitative field.
- Minimum of 7 years of experience in data science, with a significant focus on clinical trial data analysis within the pharmaceutical or biotechnology industry.
- Proven expertise in statistical modeling, machine learning algorithms (e.g., regression, classification, clustering, deep learning), and their practical application.
- Proficiency in programming languages such as Python (with libraries like Pandas, NumPy, Scikit-learn, TensorFlow/PyTorch) and R.
- Experience with clinical data standards (e.g., CDISC) and EDC systems is highly desirable.
- Strong understanding of clinical trial phases, study designs, and regulatory requirements.
- Excellent data visualization skills using tools like Matplotlib, Seaborn, Tableau, or Power BI.
- Exceptional analytical and problem-solving abilities, with a rigorous scientific approach.
- Superior written and verbal communication skills, with the ability to explain complex technical concepts clearly.
- Demonstrated ability to work independently and collaboratively in a remote team environment.
- Experience with big data technologies (e.g., Spark, Hadoop) is a plus.
Remote-First Clinical Data Manager
Posted 8 days ago
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Job Description
Key Responsibilities:
- Design, develop, and maintain electronic Case Report Forms (eCRFs) and database specifications.
- Oversee the creation and execution of data validation plans and data management plans.
- Perform data review and validation activities, identifying and resolving data discrepancies through query generation and tracking.
- Manage data cleaning activities and ensure timely database lock.
- Collaborate with statisticians and programmers to ensure data consistency and accuracy for analysis.
- Ensure compliance with GCP, regulatory guidelines (e.g., FDA, EMA), and company standard operating procedures (SOPs).
- Participate in the selection and implementation of data management systems and tools.
- Provide training and support to clinical study sites on data entry and management best practices.
- Contribute to the development and improvement of data management processes and standards.
- Act as a key point of contact for data management issues throughout the trial lifecycle.
- Bachelor's degree in a scientific, medical, or IT-related field.
- Minimum of 3 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
- Thorough understanding of the drug development process and clinical trial lifecycle.
- Proficiency with EDC systems (e.g., Medidata Rave, Oracle Clinical) and data management software.
- Knowledge of CDISC standards (SDTM, ADaM) is highly desirable.
- Strong understanding of ICH-GCP guidelines and other relevant regulatory requirements.
- Excellent attention to detail and accuracy.
- Strong organizational and problem-solving skills.
- Effective communication and interpersonal skills, suitable for a remote team environment.
- Ability to work independently, manage multiple tasks, and meet deadlines in a fast-paced setting.
Remote Clinical Data Manager - Pharmaceutical Trials
Posted today
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Job Description
Key Responsibilities:
- Oversee the design, build, and validation of clinical databases using Electronic Data Capture (EDC) systems.
- Develop data management plans (DMPs) and standard operating procedures (SOPs) for clinical data management activities.
- Ensure data quality through the implementation of robust data validation checks and query management processes.
- Manage the initiation, monitoring, and close-out of clinical databases in collaboration with clinical research associates (CRAs) and other study personnel.
- Oversee data entry and perform data review to ensure compliance with protocol requirements and regulatory standards.
- Collaborate with biostatisticians and other research teams to ensure data consistency and support statistical analysis.
- Generate data management reports, including progress updates, query status, and data quality metrics.
- Ensure compliance with Good Clinical Practice (GCP) guidelines and other relevant regulatory requirements.
- Participate in the selection and implementation of new EDC systems and data management technologies.
- Train study site personnel on data entry procedures and data management requirements.
- Contribute to the continuous improvement of data management processes and standards.