6 457 Cancer Project Manager jobs in Vietnam
Clinical Trials Manager
Posted today
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Job Description
Responsibilities:
- Manage all aspects of clinical trial execution from initiation to close-out.
- Ensure compliance with Good Clinical Practice (GCP) and all relevant regulatory requirements.
- Develop and manage clinical trial budgets and timelines.
- Select and manage clinical research sites and investigators.
- Oversee the work of Clinical Research Associates (CRAs) and ensure effective site monitoring.
- Coordinate with internal departments (e.g., data management, drug safety, regulatory affairs) and external vendors.
- Prepare and review essential study documents, including protocols, informed consent forms, and study reports.
- Identify and mitigate potential risks and issues that could impact trial conduct.
- Track trial progress and report on key performance indicators to stakeholders.
- Ensure timely data collection and query resolution.
The ideal candidate will possess strong leadership and project management skills, with a deep understanding of clinical trial operations and regulatory landscapes. Excellent communication and interpersonal skills are essential for effective collaboration with site staff, investigators, and internal teams. This hybrid role requires a balance of on-site engagement for critical site interactions and remote work for strategic planning and oversight. You will be a key contributor to bringing new therapies to market by ensuring the integrity and efficiency of our clinical research.
Qualifications:
- Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
- Minimum of 5 years of experience in clinical trial management within the pharmaceutical or biotech industry.
- Extensive knowledge of GCP, ICH guidelines, and regulatory requirements.
- Proven experience managing multiple clinical trials simultaneously.
- Strong project management skills, including budget and timeline management.
- Experience with site selection, initiation, monitoring, and close-out.
- Excellent communication, negotiation, and interpersonal skills.
- Ability to work independently and as part of a team.
- Proficiency in clinical trial management systems (CTMS) and EDC systems.
- Experience in oncology or relevant therapeutic area is a plus.
Clinical Trials Manager
Posted 8 days ago
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Senior Biostatistician - Clinical Trials
Posted 8 days ago
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Senior Data Scientist - Clinical Trials
Posted 8 days ago
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Job Description
Key Responsibilities:
- Design and implement advanced statistical analyses and machine learning models for clinical trial data.
- Develop predictive models to identify patient populations likely to respond to therapies or predict adverse events.
- Analyze large-scale datasets from various sources, including patient records, genomic data, and real-world evidence.
- Collaborate closely with clinical research teams, statisticians, and medical experts to define analytical objectives and interpret results.
- Develop data visualization tools and dashboards to effectively communicate complex findings to both technical and non-technical audiences.
- Ensure the integrity, accuracy, and reproducibility of all analyses.
- Stay current with the latest advancements in data science, machine learning, and bioinformatics, particularly within the pharmaceutical and healthcare sectors.
- Contribute to the development of data science best practices and methodologies within the organization.
- Mentor junior data scientists and contribute to the growth of the data science team.
- Present research findings at scientific conferences and contribute to publications.
- Ph.D. or Master's degree in Statistics, Computer Science, Bioinformatics, Biostatistics, or a related quantitative field.
- Minimum of 6 years of experience in data science, with a strong focus on analyzing clinical trial data or similar biomedical datasets.
- Proven expertise in statistical modeling, machine learning algorithms (e.g., regression, classification, clustering, deep learning), and experimental design.
- Proficiency in programming languages such as Python or R, and experience with relevant libraries (e.g., scikit-learn, TensorFlow, PyTorch, pandas, NumPy).
- Experience with SQL and working with large databases.
- Familiarity with clinical trial phases, regulatory requirements (e.g., FDA, EMA), and data standards (e.g., CDISC).
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively in a multidisciplinary team.
- Experience with data visualization tools (e.g., Tableau, Power BI) is a plus.
- Demonstrated ability to lead complex analytical projects and deliver impactful results.
Senior Biostatistician - Clinical Trials Analysis
Posted 8 days ago
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As a Senior Biostatistician, you will play a pivotal role in the design, execution, and analysis of clinical trials. Your responsibilities will include developing statistical analysis plans (SAPs), defining study endpoints, and performing complex statistical analyses of clinical trial data using SAS or R. You will be responsible for ensuring the accuracy and validity of statistical outputs, generating tables, figures, and listings, and preparing statistical reports for regulatory submissions and publications.
Key duties involve collaborating closely with clinical scientists, data managers, and other statisticians to ensure appropriate trial design and data collection. You will provide statistical expertise and guidance throughout the trial lifecycle, from protocol development to final study report. This includes advising on sample size calculations, randomization schemes, and interim analysis plans. You will also stay current with regulatory guidelines (e.g., FDA, EMA) and industry best practices in biostatistics.
The ideal candidate will hold a Master's or Ph.D. in Biostatistics, Statistics, or a related quantitative field, with a minimum of 7 years of relevant experience in the pharmaceutical or biotechnology industry, specifically in clinical trial biostatistics. A strong command of statistical software (SAS is required, R is a plus) and a deep understanding of statistical methodologies relevant to clinical trials are essential. Excellent analytical, problem-solving, and critical thinking skills are mandatory, along with strong written and verbal communication abilities. Experience with programming for data analysis and reporting is crucial. You must be self-motivated, detail-oriented, and able to work independently and effectively in a remote team environment. This is a significant opportunity to impact patient health by ensuring the statistical rigor of vital clinical research.
Senior Clinical Research Associate - Remote Clinical Trials
Posted 8 days ago
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Job Description
Responsibilities:
- Conduct remote and on-site monitoring visits (pre-study, initiation, routine monitoring, and close-out) to ensure study compliance.
- Verify the accuracy, completeness, and integrity of clinical trial data through source data verification (SDV) and query resolution.
- Ensure compliance with protocols, Standard Operating Procedures (SOPs), and applicable regulatory requirements (e.g., FDA, EMA, ICH-GCP).
- Act as the primary point of contact for assigned clinical trial sites, building strong relationships with investigators and site staff.
- Manage site issues and escalate them to the Clinical Operations Manager or relevant stakeholders as necessary.
- Train site personnel on study-specific procedures, regulatory requirements, and data collection processes.
- Review and approve essential regulatory documents, including Investigator Site Files (ISF).
- Contribute to the development and review of clinical study protocols and other study-related documents.
- Prepare and submit monitoring visit reports in a timely manner.
- Track study timelines and milestones, proactively identifying and mitigating risks.
Qualifications:
- Bachelor's degree in a life science, nursing, pharmacy, or a related discipline. Advanced degree preferred.
- Minimum of 5-7 years of experience as a Clinical Research Associate, with demonstrated success in managing multiple complex clinical trials.
- Extensive knowledge of GCP, ICH guidelines, and local regulatory requirements.
- Proven ability to perform remote monitoring effectively and independently.
- Excellent communication, interpersonal, and organizational skills.
- Strong problem-solving abilities and a meticulous attention to detail.
- Proficiency in using Electronic Data Capture (EDC) systems and clinical trial management systems (CTMS).
- Ability to travel occasionally for essential on-site visits (if required).
- Commitment to patient safety and data integrity.
This remote opportunity offers the chance to significantly contribute to groundbreaking pharmaceutical research while enjoying the flexibility and autonomy of a home-based role within the vibrant Pharmaceutical sector.
Clinical Research Associate - Pharmaceutical Trials
Posted 3 days ago
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Job Description
Key Responsibilities:
- Conduct pre-study, initiation, routine monitoring, and close-out visits to investigational sites.
- Ensure compliance with study protocols, Standard Operating Procedures (SOPs), and regulatory guidelines (e.g., GCP, ICH).
- Verify the accuracy, completeness, and consistency of clinical data by reviewing source documents and case report forms (CRFs).
- Manage investigational product accountability and ensure proper storage and handling.
- Oversee patient recruitment and retention strategies at study sites.
- Identify and report adverse events (AEs) and serious adverse events (SAEs) promptly.
- Provide training and ongoing support to site staff.
- Maintain accurate and up-to-date trial documentation and electronic trial master files (eTMF).
- Build and maintain strong working relationships with investigators, site staff, and internal project teams.
- Prepare monitoring visit reports and action plans.
- Bachelor's degree in a life science, nursing, or related field.
- Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial management role.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Strong understanding of medical terminology and disease states.
- Excellent written and verbal communication skills.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to investigational sites as required.
- High attention to detail and strong organizational skills.
- Problem-solving capabilities and critical thinking.
- Fluency in English is required.
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Clinical Research Associate - Pharmaceutical Trials
Posted 4 days ago
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Job Description
Responsibilities:
- Conduct on-site and remote monitoring visits to clinical trial sites.
- Ensure compliance with study protocols, GCP, and regulatory requirements.
- Verify the accuracy, completeness, and integrity of clinical data.
- Manage site initiation, interim monitoring, and close-out activities.
- Build and maintain strong relationships with investigators and site staff.
- Train site personnel on study procedures and data collection requirements.
- Monitor investigational product accountability and study supplies.
- Identify and resolve site-specific issues and deviations.
- Prepare comprehensive monitoring visit reports and follow-up actions.
- Contribute to site selection and qualification processes.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3 years of experience as a Clinical Research Associate.
- In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
- Proven experience in site monitoring and clinical trial management.
- Excellent understanding of clinical trial processes and documentation.
- Strong analytical, problem-solving, and decision-making skills.
- Exceptional organizational and time management abilities.
- Proficient in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Excellent verbal and written communication skills.
- Willingness to travel to clinical sites as required.
- Fluency in English is essential.
Remote Clinical Research Associate - Pharmaceutical Trials
Posted today
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Job Description
Key Qualifications:
- Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
- Minimum of 3-5 years of experience as a Clinical Research Associate in the pharmaceutical industry.
- In-depth knowledge of ICH-GCP guidelines and applicable regulatory requirements.
- Proven experience in monitoring clinical trial sites, both in-person and remotely.
- Excellent written and verbal communication skills, with the ability to present complex information clearly.
- Strong organizational, time management, and problem-solving abilities.
- Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Ability to work independently and manage a remote workload effectively.
Senior Clinical Research Associate, Oncology Trials
Posted 5 days ago
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Job Description
Responsibilities:
- Conduct remote site monitoring visits (according to protocol and regulations) to ensure data accuracy, patient safety, and protocol adherence for oncology clinical trials.
- Manage and oversee a portfolio of clinical trial sites, acting as the primary point of contact for investigators and site staff.
- Ensure all regulatory requirements (ICH-GCP, local regulations) are met at assigned trial sites.
- Review and verify source data, case report forms (CRFs), and other trial-related documentation.
- Oversee the initiation, conduct, and closure of clinical trial sites.
- Train and mentor junior CRAs and site personnel on study protocols, procedures, and regulatory requirements.
- Identify, evaluate, and recommend potential clinical trial sites.
- Prepare and present monitoring visit reports and action plans.
- Collaborate with cross-functional teams, including project managers, data managers, and medical monitors, to ensure successful trial execution.
- Manage investigational product accountability and drug supplies at sites.
- Ensure timely resolution of site issues and discrepancies.
- Bachelor's degree in life sciences, nursing, pharmacy, or a related scientific discipline. Advanced degree preferred.
- Minimum of 5 years of experience as a Clinical Research Associate, with a significant portion focused on oncology trials.
- In-depth knowledge of ICH-GCP guidelines, FDA regulations, and other relevant regulatory requirements.
- Proven experience in monitoring clinical trials, including remote monitoring techniques.
- Excellent understanding of oncology drug development and clinical trial protocols.
- Strong analytical and problem-solving skills.
- Exceptional organizational and time management abilities to manage multiple sites and tasks effectively.
- Outstanding written and verbal communication skills in English.
- Ability to work independently and as part of a remote, global team.
- Willingness to travel occasionally if required (though the role is primarily remote).