124 Healthcare Project Management jobs in Kenya
Clinical Trials Manager
Posted 2 days ago
Job Viewed
Job Description
Lead Clinical Trials Manager
Posted 2 days ago
Job Viewed
Job Description
Responsibilities:
- Develop and implement comprehensive clinical trial plans and protocols.
- Oversee the selection, qualification, and training of clinical investigators and study sites.
- Manage patient recruitment and retention activities to meet enrollment targets.
- Ensure adherence to GCP, regulatory requirements, and company SOPs.
- Monitor study progress, identify risks, and implement mitigation strategies.
- Manage clinical trial budgets and track expenditures.
- Review and approve clinical study reports and other essential documents.
- Liaise with regulatory authorities and ethics committees.
- Lead and mentor clinical trial staff.
- Contribute to the strategic planning of clinical development programs.
- Bachelor's or Master's degree in a life science, nursing, or related field. Advanced degree preferred.
- Minimum of 7 years of experience in clinical trial management within the pharmaceutical or biotechnology industry.
- Extensive knowledge of ICH-GCP guidelines and regulatory submission processes.
- Proven experience in managing multiple clinical trials simultaneously.
- Strong project management, organizational, and leadership skills.
- Excellent communication, negotiation, and interpersonal skills.
- Ability to work independently and effectively in a remote setting.
- Experience with various therapeutic areas is a plus.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
Clinical Research Associate - Pharmaceutical Trials
Posted 2 days ago
Job Viewed
Job Description
Key Responsibilities:
- Monitor assigned clinical trial sites to ensure compliance with protocol and GCP.
- Conduct pre-study, initiation, monitoring, and close-out visits.
- Verify accuracy and completeness of source data and CRFs.
- Ensure patient safety and rights are protected throughout the trial.
- Build and maintain strong relationships with investigators and site staff.
- Identify, document, and resolve protocol deviations and GCP non-compliance issues.
- Implement CAPAs and track their effectiveness.
- Ensure timely reporting of adverse events and safety information.
- Review and manage essential trial documents.
- Communicate effectively with study teams, sponsors, and regulatory authorities.
- 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-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
- Experience in site monitoring and clinical trial conduct.
- Strong understanding of medical terminology and disease states.
- Excellent critical thinking, problem-solving, and decision-making skills.
- Exceptional organizational, time management, and documentation skills.
- Proficiency with clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
- Excellent written and verbal communication skills.
- Ability to work independently and travel as needed (if applicable for site visits).
Clinical Research Associate - Pharmaceutical Trials
Posted 2 days ago
Job Viewed
Job Description
Senior Clinical Research Associate - Pharmaceutical Trials
Posted 2 days ago
Job Viewed
Job Description
Responsibilities:
- Conduct pre-study, initiation, routine monitoring, and close-out visits for clinical trial sites.
- Ensure adherence to study protocols, standard operating procedures (SOPs), and all applicable regulatory requirements (e.g., FDA, EMA).
- Verify the accuracy, completeness, and quality of clinical data by reviewing source documents and case report forms (CRFs).
- Manage communication between clinical sites and the sponsor, addressing any study-related issues or queries promptly.
- Train and provide guidance to site personnel on study procedures, regulatory compliance, and data management.
- Identify, document, and track site deviations and adverse events, implementing corrective and preventive actions (CAPAs).
- Prepare monitoring reports, site summaries, and other study-related documentation in a timely manner.
- Contribute to the development and review of study protocols, informed consent forms, and other trial-related documents.
- Ensure timely drug accountability and inventory management at study sites.
- Foster strong working relationships with investigators, site staff, and study sponsors.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
- Minimum of 5 years of experience as a Clinical Research Associate, with a strong background in pharmaceutical trials.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements governing clinical trials.
- Proven experience in conducting site monitoring visits and managing clinical trial documentation.
- Excellent understanding of clinical trial processes, from site selection to close-out.
- Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Strong analytical, problem-solving, and organizational skills.
- Exceptional written and verbal communication and interpersonal skills.
- Ability to work independently, manage time effectively, and travel occasionally as required for specific site visits or team meetings (while primarily remote).
- Demonstrated ability to maintain a high level of accuracy and attention to detail.
Senior Clinical Research Associate - Pharmaceutical Trials
Posted 2 days ago
Job Viewed
Job Description
Responsibilities:
- Oversee and manage multiple clinical trial sites in accordance with GCP, ICH, and local regulations.
- Conduct site initiation, interim monitoring, and close-out visits (remote and/or on-site as needed).
- Ensure accurate and timely collection of clinical data, verification of source documents, and query resolution.
- Monitor patient safety and safety reporting throughout the trial.
- Build and maintain strong relationships with investigators, site staff, and study sponsors.
- Train site personnel on study protocols, procedures, and regulatory requirements.
- Ensure all regulatory and ethical requirements are met at assigned clinical sites.
- Prepare and submit site monitoring reports and other required documentation.
- Identify potential risks and issues at clinical sites and implement corrective and preventive actions (CAPAs).
- Contribute to the development and review of clinical trial protocols and study documents.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degree preferred.
- Minimum of 5 years of experience as a Clinical Research Associate (CRA) or in a similar role within the pharmaceutical industry.
- Extensive knowledge of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
- Proven experience in managing clinical trials from start to finish.
- Strong understanding of clinical trial processes, data management, and study monitoring techniques.
- Excellent interpersonal, communication, and organizational skills, essential for remote collaboration.
- Ability to travel to sites as required for monitoring or essential activities, alongside remote duties.
- Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
- Critical thinking and problem-solving abilities.
- Fluency in English, with excellent written and verbal communication skills.
Senior Clinical Research Associate - Oncology Trials
Posted 2 days ago
Job Viewed
Job Description
As a Senior CRA, your responsibilities will include site selection, initiation, monitoring, and close-out activities for oncology clinical trials. You will build and maintain strong relationships with investigators, site staff, and study participants, providing essential support and guidance. Ensuring compliance with Good Clinical Practice (GCP), protocol requirements, and applicable regulations is paramount. You will be responsible for reviewing and verifying case report forms (CRFs), source documents, and other study-related data to ensure accuracy and completeness. This role requires a deep understanding of oncology, clinical trial methodologies, and regulatory frameworks. The ability to identify and resolve site-level issues proactively is crucial. You will also play a key role in training new CRAs and contributing to the development of clinical trial protocols and strategies. This fully remote position requires excellent organizational, communication, and interpersonal skills. Travel may be required on an as-needed basis to clinical sites, but the primary work will be conducted remotely. Our client is committed to innovation and collaboration, fostering an environment where scientific expertise drives progress. The ideal candidate will possess a Bachelor's degree in a life science or healthcare-related field, with extensive experience as a CRA in oncology studies. This role offers a rewarding career path, the chance to make a significant impact on cancer treatment, and the flexibility of remote work.
Location: This position is fully remote. The company's primary research and development operations are based in **Nyeri, Nyeri, KE**, but we are recruiting globally for this critical role.
Be The First To Know
About the latest Healthcare project management Jobs in Kenya !
Remote Clinical Research Associate - Pharmaceutical Trials
Posted 2 days ago
Job Viewed
Job Description
Responsibilities:
- Perform remote site monitoring visits (when applicable) and ensure adherence to study protocols and Good Clinical Practice (GCP) guidelines.
- Verify the accuracy and completeness of clinical data through remote review of source documents and case report forms (CRFs).
- Manage and maintain essential trial documents, ensuring regulatory compliance.
- Serve as the primary liaison between the sponsor and clinical trial sites, facilitating communication and resolving issues remotely.
- Monitor patient recruitment and retention efforts at trial sites.
- Ensure proper investigational product (IP) accountability and management at the site level.
- Train site staff on study-specific procedures and regulatory requirements via remote sessions.
- Prepare monitoring visit reports and follow up on action items with sites.
- Identify and report adverse events (AEs) and serious adverse events (SAEs) in a timely manner.
- Contribute to the overall success and integrity of clinical trials from a remote operational base.
Qualifications:
- Bachelor's degree in a life science, nursing, or a related healthcare field.
- Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial management role.
- Thorough understanding of GCP, ICH guidelines, and relevant regulatory requirements.
- Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Excellent verbal and written communication skills, with the ability to conduct professional remote interactions.
- Strong organizational and time management skills, essential for managing multiple sites remotely.
- Proficiency in Microsoft Office Suite and virtual collaboration tools.
- Ability to work independently with minimal supervision in a remote capacity.
- Must be able to operate effectively from Naivasha, Nakuru, KE .
- Relevant certifications (e.g., ACRP, SoCRA) are a plus.
This role offers a chance to be part of groundbreaking medical research and development, providing vital support to clinical trials that improve patient health globally, all within a flexible, remote work structure.
Remote Clinical Research Associate - Pharmaceutical Trials
Posted 2 days ago
Job Viewed
Job Description
Responsibilities:
- Conduct remote monitoring of clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and all applicable regulations.
- Verify the accuracy, completeness, and consistency of clinical trial data through source data verification (SDV) and other monitoring activities.
- Manage and maintain effective communication with clinical trial sites, investigators, and site staff, providing guidance and support as needed.
- Identify, document, and resolve site-level issues and discrepancies in a timely and efficient manner.
- Ensure that all regulatory documentation is accurate, complete, and maintained according to established timelines.
- Prepare for and participate in site initiation visits, interim monitoring visits, and site close-out visits, often conducted remotely or with minimal on-site presence required.
- Contribute to the development and review of study-related documents, including protocols, informed consent forms, and case report forms (CRFs).
- Oversee drug accountability and ensure proper storage and dispensing of investigational products at study sites.
- Support the safety reporting process by ensuring timely reporting of adverse events and serious adverse events.
- Foster strong working relationships with internal study teams, including data management, biostatistics, and regulatory affairs.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field. Advanced degree preferred.
- Minimum of 3-5 years of experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and methodologies.
- In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements (e.g., FDA, EMA).
- Proven experience in remote monitoring techniques and utilization of electronic data capture (EDC) systems.
- Excellent organizational skills, attention to detail, and ability to manage multiple tasks and priorities effectively in a remote setting.
- Strong analytical and problem-solving abilities.
- Exceptional written and verbal communication skills, with the ability to communicate clearly and professionally with diverse stakeholders.
- Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) software.
- Ability to work independently and collaboratively within a remote team structure.
- Commitment to maintaining the highest standards of data integrity and patient safety.
Remote Clinical Research Associate, Pharmaceutical Trials
Posted 2 days ago
Job Viewed
Job Description
Responsibilities:
- Monitor assigned clinical trial sites to ensure adherence to protocols, SOPs, and regulatory guidelines (GCP, FDA, ICH).
- Verify accuracy, completeness, and consistency of clinical trial data through source data verification (SDV).
- Initiate, monitor, and close-out clinical trial sites according to study plans.
- Train and mentor site personnel on study procedures and data collection requirements.
- Communicate effectively with investigators, study coordinators, and other site staff.
- Ensure timely submission of all required regulatory and study documents.
- Identify, track, and resolve site-related issues and deviations.
- Manage site supplies and investigational product accountability.
- Prepare trip reports and maintain accurate site visit documentation.
- Collaborate with internal teams, including project managers and data managers.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Master's degree or advanced certification in a relevant area is preferred.
- Minimum of 3-5 years of experience as a Clinical Research Associate (CRA) or equivalent role in the pharmaceutical industry.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Experience in monitoring multiple clinical trial sites and therapeutic areas.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- 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 travel to sites as needed and work independently in a remote setting.
- Detail-oriented with a strong commitment to ethical research practices.