87 Healthcare Project Management jobs in Bahrain
Clinical Trials Manager
Posted 4 days ago
Job Viewed
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.
Senior Biostatistician - Clinical Trials
Posted 1 day ago
Job Viewed
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 4 days ago
Job Viewed
Job Description
Clinical Research Associate - Oncology Trials
Posted 4 days ago
Job Viewed
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.
Clinical Research Associate - Pharmaceutical Trials
Posted 4 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
Posted 4 days ago
Job Viewed
Job Description
Clinical Research Associate - Pharmaceutical Trials
Posted 4 days ago
Job Viewed
Job Description
Be The First To Know
About the latest Healthcare project management Jobs in Bahrain !
Senior Clinical Research Associate - Oncology Trials
Posted 2 days ago
Job Viewed
Job Description
Responsibilities:
- Conduct site initiation, routine, and close-out monitoring visits in accordance with study protocols and GCP guidelines.
- Ensure the quality, integrity, and accuracy of clinical trial data through source data verification and review.
- Oversee study drug accountability and ensure compliance with investigational product management procedures.
- Identify, document, and resolve protocol deviations and regulatory compliance issues at study sites.
- Serve as the primary point of contact for assigned clinical trial sites, investigators, and study staff.
- Provide training and ongoing support to site personnel on study procedures and requirements.
- Prepare comprehensive monitoring visit reports and track site progress and action items.
- Ensure timely submission of all required regulatory and study-related documents.
- Collaborate with internal study team members (e.g., data management, project management) to ensure efficient study execution.
- Stay current with clinical research regulations, industry best practices, and therapeutic area advancements.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 5 years of experience as a Clinical Research Associate (CRA).
- Demonstrated experience in monitoring oncology clinical trials is required.
- Thorough knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
- Proficiency with Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS).
- Excellent organizational, time management, and problem-solving skills.
- Strong written and verbal communication skills, with the ability to build rapport with site staff.
- Ability to work independently and manage multiple sites remotely.
- Relevant certifications (e.g., ACRP, SoCRA) are a plus.
Senior Clinical Research Associate, Oncology Trials
Posted 2 days ago
Job Viewed
Job Description
Responsibilities:
- Conduct site qualification, initiation, interim monitoring, and close-out visits in accordance with study protocols and regulatory requirements.
- Verify the accuracy, completeness, and consistency of clinical data by reviewing source documents and case report forms (CRFs).
- Ensure compliance with GCP, ICH guidelines, and local regulations at assigned clinical trial sites.
- Build and maintain strong relationships with principal investigators, site staff, and other stakeholders.
- Identify, assess, and resolve potential issues or risks at clinical trial sites.
- Train and mentor junior CRAs and site personnel on study-specific procedures.
- Prepare and present monitoring reports, and follow up on action items.
- Ensure timely reporting of adverse events and safety information.
- Contribute to the development of study protocols, CRFs, and other study documents.
Remote Clinical Research Associate - Oncology Trials
Posted 2 days ago
Job Viewed
Job Description
Key Responsibilities:
- Conduct remote and on-site (as needed) monitoring visits to assess study conduct and data accuracy.
- Ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP) guidelines.
- Verify the accuracy and completeness of clinical data by reviewing source documents and case report forms (CRFs).
- Manage investigational product accountability and ensure proper storage and handling.
- Train and support site staff on study-related procedures and regulatory requirements.
- Build and maintain strong working relationships with investigators and site personnel.
- Prepare visit reports, follow-up letters, and other essential study documentation.
- Ensure timely reporting of adverse events and protocol deviations.
- Participate in study team meetings and contribute to risk-based monitoring strategies.
- Assist with site selection and initiation activities.
Qualifications:
- Bachelor's degree in a life science, nursing, or related field.
- Minimum of 3 years of experience as a Clinical Research Associate, with a significant focus on oncology trials.
- In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical research.
- Proven experience in conducting site monitoring visits and managing study documentation.
- Excellent understanding of medical terminology and clinical trial processes.
- Strong analytical and problem-solving skills.
- Exceptional organizational and time-management abilities.
- Outstanding written and verbal communication skills.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel as required, although the role is primarily remote.