598 Clinical Trials jobs in Bahrain
Clinical Trials Manager
Posted 20 days ago
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Job Description
Key Responsibilities:
- Develop and implement clinical trial protocols and project plans.
- Manage study budgets, timelines, and resources effectively.
- Ensure adherence to Good Clinical Practice (GCP) and other relevant regulatory guidelines.
- Oversee the recruitment and training of site staff and clinical research associates (CRAs).
- Monitor study progress and identify potential risks, implementing mitigation strategies as needed.
- Collaborate with data management teams to ensure accurate and timely data collection and reporting.
- Prepare study reports and contribute to regulatory submissions.
- Communicate effectively with internal teams, investigators, and external vendors.
Qualifications:
- Bachelor's degree in a life science, nursing, or related field; Master's degree preferred.
- Minimum of 4 years of experience in clinical trial management within the pharmaceutical or biotechnology sector.
- Strong understanding of ICH-GCP guidelines and regulatory requirements.
- Proven experience in managing multiple clinical trials simultaneously.
- Excellent leadership, project management, and communication skills.
- Ability to work effectively in a hybrid environment, balancing remote and in-office responsibilities.
- Proficiency in clinical trial management software and tools.
- Experience with specific therapeutic areas is a plus.
Remote Clinical Trials Manager
Posted 15 days ago
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Job Description
Key Responsibilities:
- Plan, manage, and execute clinical trials according to study protocols, Good Clinical Practice (GCP), and regulatory requirements.
- Oversee the selection, initiation, monitoring, and close-out of clinical trial sites.
- Develop and manage trial budgets, ensuring cost-effectiveness and timely resource allocation.
- Create and maintain essential study documents, including clinical protocols, case report forms (CRFs), and investigator brochures.
- Ensure timely data collection, query resolution, and database lock.
- Manage relationships with investigators, site staff, contract research organizations (CROs), and other vendors.
- Monitor trial progress, identify potential risks, and implement mitigation strategies to ensure study timelines are met.
- Ensure compliance with all applicable regulatory requirements (e.g., FDA, EMA) and company SOPs.
- Conduct regular site monitoring visits (remotely or on-site as required) to ensure protocol adherence and data integrity.
- Prepare study reports, including interim and final study reports.
- Contribute to the development of clinical development plans and regulatory submission documents.
- Mentor and train junior clinical research staff.
- Bachelor's degree in a life science, nursing, or related field; advanced degree (MSc, PhD) is preferred.
- Minimum of 5 years of experience in clinical trial management, with a proven track record of successfully managing Phase II and/or Phase III trials.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Experience with various therapeutic areas is desirable.
- Strong project management skills, including budgeting, scheduling, and resource allocation.
- Excellent understanding of clinical trial operations and site management.
- Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Exceptional communication, interpersonal, and leadership skills.
- Ability to work autonomously, manage multiple priorities, and thrive in a remote work environment.
- Strong problem-solving and decision-making abilities.
Senior Biostatistician - Clinical Trials
Posted 17 days ago
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Job Description
Key Responsibilities:
- Provide statistical expertise for the design of clinical trials, including sample size calculations and randomization schemes.
- Develop and review Statistical Analysis Plans (SAPs) for clinical studies.
- Perform statistical analyses of clinical trial data using appropriate software (e.g., SAS, R, SPSS).
- Interpret statistical results and contribute to the preparation of clinical study reports, manuscripts, and regulatory submissions.
- Collaborate with cross-functional teams, including clinical operations, data management, and medical affairs.
- Ensure adherence to statistical principles, regulatory guidelines (e.g., ICH), and company SOPs.
- Mentor and provide guidance to junior biostatisticians and statistical programmers.
- Contribute to the development and implementation of statistical methodologies and tools.
- Participate in scientific and technical discussions with regulatory agencies.
- Maintain up-to-date knowledge of statistical advancements and their applications in clinical research.
Qualifications:
- Ph.D. or Master's degree in Biostatistics, Statistics, or a related quantitative field.
- Minimum of 5 years of experience in biostatistics, with a focus on clinical trial design and analysis.
- Proficiency in statistical software such as SAS (highly preferred), R, or SPSS.
- In-depth knowledge of clinical trial phases, endpoints, and regulatory requirements (e.g., FDA, EMA).
- Strong understanding of statistical modeling techniques relevant to clinical research.
- Excellent analytical, problem-solving, and critical-thinking skills.
- Superior written and verbal communication skills, with the ability to present complex statistical concepts clearly.
- Proven ability to work independently and collaboratively within a remote team environment.
- Experience with data management systems and concepts related to clinical data collection.
- Demonstrated ability to manage multiple projects and meet deadlines effectively.
Senior Clinical Trials Manager
Posted 20 days ago
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Job Description
Clinical Research Associate - Pharmaceutical Trials
Posted 2 days ago
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Job Description
Key Responsibilities:
- Conduct pre-study, initiation, routine, and close-out monitoring visits at clinical trial sites.
- Verify the accuracy, completeness, and compliance of clinical trial data by reviewing source documents and electronic case report forms (eCRFs).
- Ensure adherence to the study protocol, investigational plan, and all applicable regulatory requirements (e.g., GCP, FDA, EMA).
- Assess patient safety and ensure adverse events are appropriately reported and managed.
- Verify the qualification and training of site staff involved in the clinical trial.
- Manage site supplies, including investigational product, and ensure proper storage and accountability.
- Build and maintain effective working relationships with investigators, study coordinators, and other site personnel.
- Identify site issues and develop corrective and preventive action plans (CAPAs) in collaboration with site staff and the study team.
- Prepare detailed monitoring visit reports and communicate findings and recommendations promptly.
- Assist in resolving data discrepancies and queries from the data management team.
- Ensure timely submission of essential study documents.
- Stay updated on regulatory guidelines and company policies related to clinical research.
Qualifications:
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline.
- Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial monitoring role.
- In-depth knowledge of ICH-GCP guidelines and other relevant regulatory requirements.
- Experience in site management, including site selection, initiation, monitoring, and close-out.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Excellent monitoring skills, including source data verification and query resolution.
- Strong written and verbal communication skills, with the ability to communicate effectively with healthcare professionals.
- Highly organized with strong attention to detail and ability to manage multiple priorities.
- Ability to work independently and travel to clinical sites as required by the hybrid model.
- Knowledge of specific therapeutic areas is an advantage.
This is a critical role within our research and development division, offering the chance to impact patient care and contribute to the development of innovative pharmaceuticals. This hybrid position requires regular presence at our Tubli, Capital, Bahrain office.
Clinical Research Associate - Pharmaceutical Trials
Posted 11 days ago
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Job Description
Key Responsibilities:
- Conduct site visits (initiation, monitoring, and close-out) to ensure compliance with protocols, SOPs, and GCP.
- Verify the accuracy, completeness, and consistency of clinical trial data through source document verification.
- Manage and maintain trial master files (TMF) and site regulatory documents.
- Oversee drug accountability and ensure proper handling and storage of investigational products.
- Train and support site staff on study-related procedures and regulatory requirements.
- Identify and resolve site-specific issues, escalating as necessary.
- Communicate effectively with investigators, study coordinators, and internal project teams.
- Prepare monitoring reports and ensure timely submission of study-related documentation.
- Participate in study team meetings and contribute to protocol development and amendments.
Required Qualifications:
- Bachelor's degree in a life science, nursing, or a related field.
- Minimum of 3-5 years of direct experience as a Clinical Research Associate.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
- Demonstrated experience in site monitoring and data verification.
- Excellent organizational skills and attention to detail.
- Strong verbal and written communication abilities.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to clinical sites as required (estimated 30-50% travel).
- A proactive approach to problem-solving and a commitment to ethical research practices.
This position is located in Riffa, Southern, BH , with a hybrid work arrangement. If you are passionate about advancing medical research and possess the required expertise, we encourage you to apply.
Clinical Research Associate - Oncology Trials
Posted 20 days ago
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Job Description
As a remote CRA, you will be responsible for site selection, initiation, monitoring, and close-out activities for clinical trial sites. This includes verifying the accuracy and integrity of study data, ensuring patient safety, and maintaining all necessary documentation. You will serve as the primary liaison between the investigative sites and the sponsor, fostering strong working relationships and facilitating effective communication.
Key responsibilities include:
- Conducting pre-study visits (PSVs) to assess the suitability of potential clinical sites.
- Initiating sites by ensuring all necessary documentation is in place and regulatory requirements are met.
- Performing routine monitoring visits (on-site or remote, as applicable) to verify source data verification (SDV), assess protocol adherence, and ensure patient safety.
- Ensuring timely collection, review, and reconciliation of study data, including electronic data capture (EDC) and query resolution.
- Managing all aspects of site close-out, including the retrieval of essential documents and case report forms (CRFs).
- Providing training and ongoing support to investigators and site staff on study protocols and procedures.
- Identifying, documenting, and escalating study-related issues and risks to the study team.
- Ensuring compliance with Good Clinical Practice (GCP), FDA regulations, and other applicable guidelines.
- Maintaining accurate and up-to-date trial master file (TMF) documentation.
- Communicating effectively with internal study teams and external investigators.
The ideal candidate will have a Bachelor's degree in a life science, nursing, or a related field. A minimum of 3 years of experience as a CRA, with a strong background in oncology clinical trials, is essential. Thorough knowledge of ICH-GCP guidelines and regulatory requirements is mandatory. Excellent organizational, problem-solving, and communication skills are required. The ability to work independently, manage multiple priorities, and travel occasionally as needed (if required by study) is also important. This role offers an exciting opportunity to contribute to groundbreaking research from a remote location, impacting patient care in **Tubli, Capital, BH**, and globally.
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Clinical Research Associate - Pharmaceutical Trials
Posted 20 days ago
Job Viewed
Job Description
Key Responsibilities:
- Performing site selection, initiation, monitoring, and close-out visits to clinical trial sites.
- Ensuring that all study conduct adheres to the approved protocol, Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP) guidelines.
- Verifying the accuracy, completeness, and consistency of clinical data through source document verification.
- Monitoring patient safety and reporting adverse events according to regulatory requirements.
- Managing communication between the sponsor, clinical investigators, and site staff.
- Ensuring timely submission of essential study documents.
- Identifying, tracking, and resolving site-related issues and deviations.
- Training and mentoring site staff on protocol requirements and data collection procedures.
- Preparing and presenting study progress reports to internal stakeholders.
- Maintaining accurate and up-to-date trial master files and site files.
The ideal candidate will possess a Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. A minimum of 3 years of experience as a Clinical Research Associate or in a similar role within the pharmaceutical or biotechnology industry is required. Comprehensive knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials is essential. Demonstrated experience in monitoring clinical trials and performing site visits is mandatory. Excellent communication, organizational, and interpersonal skills are necessary. The ability to travel to clinical sites as required is crucial for this hybrid role. Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is highly desirable. This position plays a vital role in bringing new medicines to patients. The primary focus area is around Hamad Town, Northern, BH .
Clinical Research Associate - Pharmaceutical Trials (Remote)
Posted 7 days ago
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Job Description
Senior Clinical Research Associate - Oncology Trials
Posted 9 days ago
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Job Description
Responsibilities:
- Conduct pre-study, initiation, routine monitoring, and close-out visits for clinical trial sites in and around Hamad Town, Northern, BH .
- Ensure compliance with Good Clinical Practice (GCP), protocol requirements, and all applicable regulatory guidelines.
- Manage investigational product accountability at study sites.
- Act as the primary liaison between study sites and the clinical trial team, fostering strong working relationships.
- Review and reconcile essential study documents, including regulatory binders, source documents, and case report forms (CRFs).
- Identify and report adverse events and serious adverse events according to protocol and regulatory requirements.
- Train and mentor site staff on study procedures, protocol amendments, and data collection.
- Participate in investigator meetings and site initiation meetings.
- Contribute to the development of study-related documents, such as protocols and monitoring plans.
- Identify potential risks and issues at study sites and develop mitigation strategies.
- Ensure timely data entry and query resolution.
- Communicate effectively with internal stakeholders, including project managers, data managers, and medical monitors.
- Bachelor's degree in a life science, nursing, or a related field. Master's degree or PhD is a plus.
- Minimum of 5 years of experience as a Clinical Research Associate, with a strong emphasis on oncology trials.
- In-depth knowledge of ICH-GCP guidelines and local regulatory requirements in Bahrain.
- Proven ability to manage multiple sites and complex trials simultaneously.
- Excellent communication, interpersonal, and organizational skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to study sites within the region as required for monitoring activities.
- Demonstrated ability to work independently and as part of a collaborative team.
- Strong problem-solving skills and attention to detail.
- Fluency in English is essential; knowledge of Arabic is advantageous.