215 Healthcare Project Management jobs in Indonesia
Clinical Trials Manager
28112 Pekanbaru, Riau
IDR18000000 Annually
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Posted 3 days ago
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Job Description
Our client, a pioneering pharmaceutical company, is seeking an experienced and dedicated Clinical Trials Manager to lead critical research projects in Pekanbaru, Riau, ID . This role is essential for the successful execution of clinical studies, ensuring they meet regulatory requirements and project timelines. The Clinical Trials Manager will be responsible for the planning, implementation, and oversight of all aspects of clinical trials, from site selection and initiation to data collection and close-out. This position demands a strong understanding of clinical research methodologies, regulatory affairs, and project management principles.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop and manage clinical trial protocols, budgets, and timelines.
- Identify, evaluate, and select clinical trial sites and investigators.
- Oversee the conduct of clinical trials in compliance with Good Clinical Practice (GCP) guidelines, ICH guidelines, and local regulations.
- Manage and mentor Clinical Research Associates (CRAs) and other study personnel.
- Ensure accurate and timely collection, cleaning, and analysis of clinical trial data.
- Liaise with regulatory authorities and ethics committees to obtain necessary approvals.
- Monitor trial progress and identify any potential risks or issues, implementing mitigation strategies.
- Manage vendor relationships, including contract research organizations (CROs) and central labs.
- Ensure study supplies, including investigational products, are managed appropriately.
- Prepare and submit regulatory documents, progress reports, and final study reports.
- Organize and conduct investigator meetings and site monitoring visits.
- Facilitate effective communication among study team members, investigators, and stakeholders.
- Manage safety reporting and pharmacovigilance activities for the trial.
- Contribute to the development of new clinical research strategies and initiatives.
- Ensure the quality and integrity of clinical trial data.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. A Master's degree or Ph.D. is preferred.
- Minimum of 6 years of experience in clinical trial management within the pharmaceutical or biotechnology industry.
- In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
- Proven experience in managing multiple clinical trials simultaneously.
- Strong project management skills, including budgeting and timeline management.
- Excellent leadership, communication, and interpersonal skills.
- Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Ability to travel to clinical sites as needed.
- Experience in therapeutic areas relevant to the company's pipeline is a plus.
- Strong analytical and problem-solving skills.
- This role is based at our facility in Pekanbaru, Riau, ID and requires a dedicated on-site presence.
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Clinical Trials Manager
20111 Medan, North Sumatra
IDR20 Monthly
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Posted 8 days ago
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Job Description
Our client, a leading pharmaceutical company dedicated to advancing global health outcomes, is seeking an experienced and highly organized Clinical Trials Manager. This role is critical for overseeing the successful execution of clinical trials from initiation to completion, ensuring compliance with all regulatory requirements and ethical standards. The position is based at our facility in Medan, North Sumatra, ID .
Responsibilities:
The ideal candidate will possess a strong background in clinical research, with a proven track record of successfully managing multi-center clinical trials. Excellent leadership, organizational, and problem-solving skills are essential. This role demands a meticulous approach to detail and a deep understanding of the pharmaceutical development process. You will be expected to work collaboratively within a dedicated team and contribute to the strategic direction of our clinical research endeavors. The base in Medan, North Sumatra, ID is a vibrant hub for our research activities, and we are looking for a dedicated professional to join our mission.
Responsibilities:
- Develop and manage clinical trial protocols, budgets, and timelines in collaboration with investigators and study teams.
- Oversee the planning, initiation, and monitoring of clinical trial sites to ensure data integrity and patient safety.
- Ensure adherence to Good Clinical Practice (GCP) guidelines, FDA regulations, and other relevant international standards.
- Manage relationships with Contract Research Organizations (CROs) and other vendors involved in clinical trials.
- Coordinate the collection, management, and analysis of clinical trial data.
- Prepare and submit essential documents for Institutional Review Board (IRB) and regulatory agency approvals.
- Conduct site initiation visits, interim monitoring visits, and close-out visits.
- Identify and mitigate risks associated with clinical trial execution.
- Train and mentor clinical research associates and other study personnel.
- Prepare comprehensive clinical study reports and contribute to scientific publications.
- Maintain clear and consistent communication with internal stakeholders, investigators, and regulatory bodies.
- Manage drug supply and investigational product accountability throughout the trial.
The ideal candidate will possess a strong background in clinical research, with a proven track record of successfully managing multi-center clinical trials. Excellent leadership, organizational, and problem-solving skills are essential. This role demands a meticulous approach to detail and a deep understanding of the pharmaceutical development process. You will be expected to work collaboratively within a dedicated team and contribute to the strategic direction of our clinical research endeavors. The base in Medan, North Sumatra, ID is a vibrant hub for our research activities, and we are looking for a dedicated professional to join our mission.
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1
Senior Clinical Trials Manager
20143 Medan, North Sumatra
IDR19000000 Annually
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Posted 8 days ago
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Job Description
Our client is looking for a highly motivated and experienced Senior Clinical Trials Manager to lead and oversee complex clinical research projects in Medan, North Sumatra, ID . This role is critical in ensuring the successful planning, execution, and completion of clinical trials in compliance with all regulatory requirements and ethical standards. You will be responsible for managing study timelines, budgets, and resources, as well as overseeing the work of clinical research associates (CRAs) and other study personnel. Key responsibilities include developing clinical trial protocols, managing site selection and initiation, monitoring site performance, and ensuring data integrity. You will act as the primary point of contact for investigative sites, ethics committees, and regulatory authorities. The ideal candidate will have a strong understanding of Good Clinical Practice (GCP) guidelines and relevant international regulations. Proven experience in project management within the pharmaceutical or biotech industry is essential. You will be adept at identifying and mitigating risks, resolving issues, and ensuring that trials are conducted efficiently and to the highest quality standards. Excellent leadership, communication, and interpersonal skills are required to effectively manage cross-functional teams and build strong relationships with external partners. A Bachelor's degree in a life science, nursing, or a related field is required; a Master's degree or relevant certifications are preferred. This position offers a hybrid work arrangement, providing a balance between essential on-site collaboration and remote flexibility. You will contribute significantly to bringing innovative therapies to patients by ensuring the rigorous and ethical conduct of clinical research.
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2
Senior Biostatistician - Clinical Trials
16115 Bogor, West Java
IDR18000000 Monthly
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Posted 8 days ago
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Job Description
Our client is a rapidly growing Contract Research Organization (CRO) dedicated to supporting pharmaceutical and biotech companies in bringing life-saving therapies to market. We are seeking an experienced Senior Biostatistician to join our team and contribute to the design, analysis, and reporting of clinical trials. This role offers a hybrid work arrangement, allowing for flexibility between remote work and in-office collaboration in **Bogor, West Java, ID**. The successful candidate will be responsible for developing statistical analysis plans, performing complex statistical analyses, and ensuring the integrity and accuracy of clinical trial data. You will work closely with clinical researchers, data managers, and other statisticians to interpret results and contribute to regulatory submissions. A strong understanding of statistical methodologies applied to clinical trials, regulatory guidelines (e.g., FDA, EMA), and proficiency in statistical software are essential. This is an excellent opportunity for a meticulous and analytical professional to make a significant impact on medical research and patient outcomes.
Responsibilities:
Qualifications:
Responsibilities:
- Develop and finalize statistical analysis plans (SAPs) for clinical trials.
- Perform statistical analyses of clinical trial data using SAS, R, or other relevant software.
- Design clinical trial protocols, ensuring appropriate statistical methodology.
- Collaborate with investigators and study teams to ensure data quality and integrity.
- Interpret statistical results and provide clear, concise summaries for reports and publications.
- Contribute to the preparation of clinical study reports (CSRs) and regulatory submissions.
- Participate in the review of clinical data management activities.
- Stay up-to-date with the latest statistical methodologies and regulatory requirements.
- Mentor and guide junior biostatisticians.
- Present statistical findings to internal teams and external stakeholders.
Qualifications:
- Master's or Ph.D. in Biostatistics, Statistics, or a closely related quantitative field.
- Minimum of 5 years of experience in biostatistics within the pharmaceutical or CRO industry, focusing on clinical trials.
- Proficiency in SAS and/or R for statistical analysis.
- Solid understanding of clinical trial design and methodologies.
- Knowledge of ICH guidelines and regulatory requirements for clinical data.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills.
- Ability to work effectively in a hybrid team environment.
- Experience with programming for data visualization is a plus.
- Detail-oriented with a commitment to accuracy and scientific rigor.
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3
Clinical Research Associate - Oncology Trials
15311 Tangerang, Banten
IDR12000000 Annually
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Posted 7 days ago
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Job Description
Our client, a leading pharmaceutical company, is seeking an experienced Clinical Research Associate (CRA) to contribute to groundbreaking oncology research in Tangerang, Banten, ID . This pivotal role involves overseeing and managing clinical trials to ensure they are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements. As a CRA, you will be responsible for site selection, initiation, monitoring, and close-out activities, ensuring data integrity and patient safety throughout the trial lifecycle. The ideal candidate will possess a strong understanding of pharmaceutical research, excellent attention to detail, and the ability to build effective relationships with investigators and site staff.
Key Responsibilities:
Key Responsibilities:
- Conduct site visits to assess site feasibility, initiate new sites, monitor ongoing trial progress, and manage site close-out.
- Ensure adherence to study protocols, SOPs, and regulatory guidelines at investigative sites.
- Verify the accuracy, completeness, and validity of clinical trial data by reviewing source documents and case report forms (CRFs).
- Monitor patient safety and report adverse events and serious adverse events promptly and accurately.
- Train and mentor site staff on study-specific procedures, regulatory requirements, and data collection methods.
- Manage and maintain essential trial documents, ensuring regulatory compliance.
- Build and maintain strong working relationships with investigators, study coordinators, and other site personnel.
- Identify and report potential risks and issues at study sites, and work collaboratively to develop and implement corrective action plans.
- Prepare monitoring visit reports and communicate findings to study teams and management.
- Ensure timely retrieval and reconciliation of study supplies and investigational product.
- Participate in Investigator Meetings and other relevant training sessions.
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field. Advanced degree preferred.
- Minimum of 3 years of experience as a Clinical Research Associate, with a focus on oncology trials.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Proven experience in monitoring clinical trial sites and managing data integrity.
- Excellent understanding of medical terminology and disease processes, particularly in oncology.
- Strong analytical, problem-solving, and organizational skills.
- Exceptional written and verbal communication skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel frequently to study sites as required.
- Demonstrated ability to work independently and as part of a cross-functional team.
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4
Clinical Research Associate - Pharmaceutical Trials
32114 Bandar Lampung, Lampung
IDR11000000 Annually
WhatJobs
Posted 8 days ago
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Job Description
Our client, a leading pharmaceutical company dedicated to improving global health outcomes, is seeking a meticulous and experienced Clinical Research Associate (CRA) to join their team in Bandar Lampung, Lampung, ID . This role is essential for overseeing and managing clinical trial sites, ensuring adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. The ideal candidate will possess strong organizational skills, excellent attention to detail, and a thorough understanding of the clinical trial process. This position requires regular on-site visits to trial locations.
Key Responsibilities:
Key Responsibilities:
- Monitor clinical trial sites to ensure data accuracy, protocol compliance, and patient safety.
- Verify the collection, recording, and reporting of clinical data according to protocol requirements.
- Ensure compliance with all applicable regulatory requirements, including GCP, ICH guidelines, and local regulations.
- Conduct site initiation visits, interim monitoring visits, and close-out visits.
- Train site staff on study procedures, regulatory requirements, and data collection processes.
- Manage study supplies and accountability of investigational product at clinical sites.
- Review and ensure the accuracy and completeness of source documents and case report forms (CRFs).
- Identify, report, and resolve site-level issues and deviations in a timely manner.
- Communicate effectively with investigators, site staff, and internal project teams.
- Prepare monitoring reports and maintain accurate site files and essential regulatory documents.
- Participate in the selection and qualification of new clinical trial sites.
- Contribute to the development of clinical trial protocols and other study-related documents.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
- Minimum of 3 years of experience as a Clinical Research Associate or in a related clinical research role.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Proven experience in monitoring clinical trial sites and managing study conduct.
- Excellent understanding of medical terminology and clinical trial processes.
- Strong organizational, problem-solving, and time management skills.
- Exceptional communication, interpersonal, and presentation skills.
- Proficiency in clinical trial management software and electronic data capture (EDC) systems.
- Ability to travel regularly to assigned clinical trial sites.
- Detail-oriented with a high level of accuracy and integrity.
- Experience working with pharmaceutical companies or Contract Research Organizations (CROs) is preferred.
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5
Clinical Research Associate, Pharmaceutical Trials
17111 Bekasi, West Java
IDR11000000 Monthly
WhatJobs
Posted 8 days ago
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Job Description
Our client, a prominent pharmaceutical company, is actively seeking a dedicated Clinical Research Associate (CRA) to oversee and manage clinical trial sites. This role is crucial for ensuring the integrity, accuracy, and timeliness of clinical trial data, adhering strictly to Good Clinical Practice (GCP) guidelines and regulatory requirements. The CRA will be responsible for site selection, initiation, monitoring, and close-out activities, acting as the primary liaison between the sponsor and the investigational sites. This position demands a thorough understanding of clinical trial processes, excellent organizational skills, and the ability to build strong professional relationships.
Key responsibilities include conducting pre-study visits to assess site eligibility, initiating studies at approved sites, and providing essential training to site staff on study protocols and procedures. The CRA will perform routine site monitoring visits to verify data accuracy, ensure patient safety, and confirm adherence to protocols. They will also manage essential study documents, resolve data queries, and ensure that all regulatory requirements are met. The ability to travel frequently to various clinical sites is a requirement of this role. Strong analytical skills are needed to identify potential issues and implement corrective actions promptly.
Key responsibilities:
Qualifications:
This position is located in Bekasi, West Java, ID and offers a competitive salary, benefits, and the opportunity to advance your career in clinical research within the pharmaceutical sector.
Key responsibilities include conducting pre-study visits to assess site eligibility, initiating studies at approved sites, and providing essential training to site staff on study protocols and procedures. The CRA will perform routine site monitoring visits to verify data accuracy, ensure patient safety, and confirm adherence to protocols. They will also manage essential study documents, resolve data queries, and ensure that all regulatory requirements are met. The ability to travel frequently to various clinical sites is a requirement of this role. Strong analytical skills are needed to identify potential issues and implement corrective actions promptly.
Key responsibilities:
- Conduct site selection, initiation, interim monitoring, and close-out visits.
- Ensure compliance with clinical trial protocols, GCP guidelines, and regulatory requirements.
- Verify the accuracy, completeness, and quality of data collected at clinical sites.
- Train and support site staff on study-specific procedures and documentation.
- Manage investigational product accountability and investigational site supplies.
- Resolve data queries and ensure timely resolution of issues identified during monitoring visits.
- Maintain accurate and up-to-date trial master file (TMF) documentation.
- Report trial progress, site status, and any potential risks or issues to the project team.
- Ensure patient safety and ethical conduct of the study at all times.
- Collaborate effectively with investigators, site staff, and internal project teams.
Qualifications:
- Bachelor's degree in a life science, nursing, or a related field.
- Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar clinical trial management role.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Experience in site monitoring, data management, and regulatory documentation.
- Excellent interpersonal, communication, and presentation skills.
- Strong organizational and time management abilities, with meticulous attention to detail.
- Proficiency in clinical trial management software and electronic data capture (EDC) systems.
- Ability to travel frequently, as required by the role (up to 50-70%).
- Problem-solving skills and the ability to work independently.
This position is located in Bekasi, West Java, ID and offers a competitive salary, benefits, and the opportunity to advance your career in clinical research within the pharmaceutical sector.
This advertiser has chosen not to accept applicants from your region.
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6
Remote Clinical Data Manager - Pharmaceutical Trials
50131 Semarang, Central Java
IDR17000000 Annually
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Posted today
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Job Description
Our client, a leading pharmaceutical research organization, is seeking a meticulous and experienced Remote Clinical Data Manager to play a vital role in their clinical trial operations. This fully remote position allows you to manage critical data from clinical studies across various geographical locations. You will be responsible for the design, development, and maintenance of clinical databases, ensuring data accuracy, completeness, and integrity throughout the trial lifecycle. The ideal candidate will have a strong understanding of clinical trial processes, data management systems (e.g., EDC systems), regulatory requirements (e.g., ICH GCP), and statistical analysis principles. Experience with EDC platform development, data validation, and query management is crucial.
Key Responsibilities:
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.
This advertiser has chosen not to accept applicants from your region.
7
Senior Clinical Research Associate - Oncology Trials
16111 Depok, West Java
IDR700 Annually
WhatJobs
Posted 2 days ago
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Job Description
Our client is seeking a highly skilled and experienced Senior Clinical Research Associate (CRA) to oversee critical oncology clinical trials. This role demands a thorough understanding of clinical trial management, regulatory requirements, and patient safety protocols. You will be responsible for monitoring trial sites, ensuring data accuracy, and maintaining compliance with Good Clinical Practice (GCP) guidelines and protocol requirements. This position offers a hybrid work model, balancing remote responsibilities with on-site visits to study centers in and around **Depok, West Java, ID**.
Key responsibilities include initiating, monitoring, and closing out clinical trial sites. You will ensure that investigational sites are properly equipped, staffed, and trained to conduct the trial. The Senior CRA will verify the accuracy, completeness, and integrity of study data through source data verification and review of case report forms (CRFs). You will act as the primary point of contact between the sponsor and investigative sites, fostering strong relationships and resolving site-related issues promptly. The ideal candidate will have extensive experience in managing complex oncology trials, a deep understanding of drug development processes, and a commitment to upholding the highest ethical and quality standards. Strong organizational, communication, and problem-solving skills are essential. You will also be involved in regulatory document review and submission preparation.
Responsibilities:
Key responsibilities include initiating, monitoring, and closing out clinical trial sites. You will ensure that investigational sites are properly equipped, staffed, and trained to conduct the trial. The Senior CRA will verify the accuracy, completeness, and integrity of study data through source data verification and review of case report forms (CRFs). You will act as the primary point of contact between the sponsor and investigative sites, fostering strong relationships and resolving site-related issues promptly. The ideal candidate will have extensive experience in managing complex oncology trials, a deep understanding of drug development processes, and a commitment to upholding the highest ethical and quality standards. Strong organizational, communication, and problem-solving skills are essential. You will also be involved in regulatory document review and submission preparation.
Responsibilities:
- Conduct pre-study, initiation, interim, and close-out monitoring visits.
- Ensure study sites comply with GCP, protocol, and regulatory requirements.
- Verify the accuracy, completeness, and validity of clinical trial data.
- Manage communication between study sites, the sponsor, and relevant stakeholders.
- Train site personnel on study protocols, procedures, and regulatory compliance.
- Oversee drug accountability and investigational product management at sites.
- Identify and resolve site-level issues and discrepancies promptly.
- Prepare and submit accurate and timely monitoring visit reports.
- Review essential regulatory documents for completeness and accuracy.
- Contribute to the development of study protocols and Case Report Forms (CRFs).
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- 5+ years of experience as a Clinical Research Associate (CRA), with a significant focus on oncology trials.
- In-depth knowledge of GCP, ICH guidelines, and local regulatory requirements.
- Experience with various phases of clinical trials (Phase I-IV).
- Strong understanding of medical terminology and disease processes, especially in oncology.
- Excellent monitoring and site management skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Exceptional written and verbal communication skills.
- Strong organizational, analytical, and problem-solving abilities.
- Ability to travel to study sites as required and work effectively in a hybrid model.
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8
Senior Clinical Research Associate - Oncology Trials
40111 Bandung, West Java
IDR12000000 Annually
WhatJobs
Posted 8 days ago
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Job Description
Our client, a prominent pharmaceutical company, is seeking a dedicated and experienced Senior Clinical Research Associate (CRA) to join their dynamic team in Bandung, West Java, ID . This role offers a hybrid work model, providing a balanced approach to fieldwork and remote data management. As a Senior CRA, you will be responsible for overseeing clinical trials, ensuring compliance with protocols, regulations, and Good Clinical Practice (GCP) guidelines, and maintaining the integrity of study data. You will play a crucial role in the successful execution of oncology clinical trials, working closely with investigators, site staff, and internal project teams to achieve study objectives and ensure patient safety.
Responsibilities:
Responsibilities:
- Conduct site selection, initiation, monitoring, and close-out visits for clinical trial sites.
- Ensure study conduct adheres to the approved protocol, GCP, and applicable regulatory requirements.
- Monitor data accuracy and completeness, identifying and resolving discrepancies in a timely manner.
- Manage communication between study sites, principal investigators, and the sponsor.
- Train and support site personnel on study procedures, regulatory requirements, and data collection.
- Oversee drug accountability and management at study sites.
- Identify and report adverse events (AEs) and serious adverse events (SAEs) according to protocol.
- Prepare comprehensive monitoring visit reports and follow-up on action items.
- Contribute to the development of study documents, including protocols, case report forms (CRFs), and investigator brochures.
- Ensure timely submission of required study documentation.
- Bachelor's degree in a life science, nursing, or related field.
- Minimum of 5 years of experience as a Clinical Research Associate, with a strong focus on oncology trials.
- In-depth knowledge of ICH-GCP guidelines and local regulatory requirements.
- Proven experience in conducting monitoring visits and managing clinical trial sites.
- Excellent understanding of clinical trial processes, from initiation to close-out.
- Strong analytical and problem-solving skills, with meticulous attention to detail.
- Exceptional organizational and time management abilities.
- Excellent written and verbal communication skills in Indonesian and English.
- Ability to work independently and collaboratively in a hybrid environment.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
This advertiser has chosen not to accept applicants from your region.
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