82 Clinical Affairs jobs in Bahrain

Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, & Analytical Industries.

The incumbent is responsible for all Product Classification/Manufacturing Site Registration and Product Registration and to ensure that all documents required are available and are submitted on time.

ACCOUNTABILITIES

Adhere to all Zahrawi Policies & Procedures as applicable.

Regulatory Affairs:

Ensure that Zahrawi’s products comply with the regulations of the NHRA.

Keep up to date with the latest changes in regulatory legislation and guidelines.

Liaise and negotiate with regulatory authority to ensure a smooth registration process.

Provide advice about regulations to customers/suppliers.

Analyze product complaints and make recommendations to solve the problem and to avoid them in the future.

• Prepare and apply for the permit document as per the NHRA guidelines and verify the items being imported and the documents required.
• Apply for the NHRA regulated products permits on the NHRA website as per the specified guidelines.
• Register and submit the permits for SCE when required.
• Resubmit any permits that have not been approved and make sure all the information provided is correct and attach any new documents if required.
• Prepare daily report regarding the rejections/ delays for NHRA importation permits and reasons related to that.
• Communicate with the existing and new suppliers regarding NHRA importation rules and policies.
• Upload on the NHRA importation system any new classifications or registration certificates.
• Ensure that all urgent requests from the Sales team and suppliers are dealt with in a fast manner and ensure that all documents are in place.
• Report any deviation from NHRA guidelines of imported shipments and take the corrective and preventive action accordingly.
• Review on a regular basis the NHRA importation process of distribution agreements.
• Ensure that the NHRA license is renewed before expiry date to avoid importation disturbance.
• Segregate the imported products as per HS code in coordination with logistic team and confirm if products are NHRA regulated or not.
• Coordinate with the Procurement & Logistics Team to update all the required documents in time to avoid importation rejections.
• Act as the LRPPV (Local Responsible Person for Pharmacovigilance).
• Perform regulatory intelligence by screening the NHRA websites on a weekly basis.
• Screen all scientific and medical literature to stay up to date with the latest regulations.
• Comply with local regulatory requirements for reporting adverse drug reactions and submission of safety reports.
• Responsible for all Pharmacovigilance related work and assigned as the LRPPV (Local Responsible Person for Pharmacovigilance).
• Report Adverse Drug Reactions (ADRs) for all products by collating the needed information and incorporating customer’s comments.
• Fill the Council for International Organizations of Medical Sciences (CIOMS) forms with all the information collected from the ADRs.
• Send all CIOMS forms to the Manufacturers and the relevant authorities.
• Manage the Pharmacovigilance process of Zahrawi by preparing all SOPs, product safety reviews and literature reviews when needed.
• Maintain a high level of standard to ensure that all work is moving smoothly and that there are no delays.
• Prepare and review all SOP’s Pharmacovigilance plans for all Zahrawi Suppliers.
• Prepare all Registration and Pharmacovigilance forms and communicate the same to the Suppliers and stakeholders.
• Provide trainings to all internal divisions on the current Pharmacovigilance Policies & Procedures.

Individual Case Study Reports (ICSRs):

• Report any spontaneous Individual Case Study Reports (ICSRs) to the Supplier and the Health Authority.
• Maintain a soft and hard copy of all ICSRs for the future.
• Track and follow up with all active ICSR reconciliation with the respective authorities.
• Report all Suspected and Unexpected Serious Adverse Reactions to relevant Health Authorities.

Product Classification & Registration:

Ensure that all required documents and actions for Product Classification/Manufacturing Site Registration and Product Registration are available.

Prepare all required documents to be submitted for Product Classification under NHRA.

Prepare all required documents to be submitted for Manufacturing Site registration under NHRA.

Prepare all the Dossiers to be submitted to NHRA for product registration.

Collect all necessary documents from Supplier to submit for Health Authorities.

Quality Assurance:

• Monitor all Cold Products from point of receiving until delivery of products to customers along with Data Logger results within the set temperature limits.
• Examine the packing of goods from the cold storage and monitor the Data Logger Report to ensure consistency.
• Check the quality of the vehicles, warehouse cleanliness, temperature control mechanism, storage conditions and validity of goods on shelves on a regular basis.
• Ensure all Zahrawi Cold Vans/Delivery Vehicles, Data Loggers are calibrated regularly and update the temperature mapping of the Warehouse.
• Ensure all required licenses and registrations as well as calibration renewals are updated before their expiry dates.
• Review all technical and quality agreements with suppliers and customers on a regular basis.

Warehouse Quality Check:

Ensure that the Warehouse & Service Room are kept clean and organized.

Ensure that the temperature control mechanism and hygiene standards are maintained in the Warehouse.

Ensure a quick and accurate release of shipments from NHRA to avoid any delays in transporting the products to the customer.

Ensure that all stock areas are segregated properly into: Dispatching, Receiving, Returns, Hold and Expired and that no mix-up could happen at any time.

Product Quality Check:

Ensure that a sample of each batch of products is secured from the WH Assistants and provide the samples along with a progress report and supplier invoice to the Warehouse Operation, QA & RA Manager for NHRA release approval.

Check all shipments leaving the Warehouse are sealed and packed properly and if the vehicle is fit for transporting the products.

Compile all Quality Inspection Forms prepared by the Sr. Driver & Fleet Coordinator and prepare a monthly report.

Generate a discrepancy report to the Warehouse Operation, QA & RA Manager for MOH release approval for any late findings (excess, damaged or expired goods) in the shipment.

Audit:

• Prepare any documentation needed for internal and external audits.
• File all documents in the corresponding files to ensure all are available and are correct.
• Evaluate the suggestions after the audit and implement them when possible.

Admin:

• Develop a professional relationship with the NHRA staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations.
• Represent Zahrawi in NHRA and different authorities.
• Negotiate with regulatory authorities for marketing authorization.
• Attend and respond to calls and emails from customers, the Sales team and other support staff.
• Assist the Warehouse Coordinators with relevant documents when requested.
• Coordinate with the Procurement team and assist them with any question they or the Suppliers may have related to NHRA importation.
• Keep track of all registration application on Zahrawi’s tracking system.
• Record all active Zahrawi licenses on the Shared folder and ensure they are updated.

• Education: Bachelors Degree in Pharmacy
• Candidates must be based in Bahrain.
• Bahraini national is preferred.
• Candidates must have a valid Pharmacist license.
• RAO license is a plus.
• Experience: Fresh graduates or 1+ years of relevant experience in regulatory affairs within Bahrain is preferred.
• Job Specific Skills: Excellent Interpersonal Skills & Good English – Good computer skills in Ms. Office (Excel– ERP/Oracle system) - Knowledge about Regulatory Affairs, Product Classification and Importation Regulations as per NHRA.

• Conduct site visits (initiation, interim, and close-out) to assess protocol compliance, data accuracy, and overall study progress.
• Verify that all clinical trial activities are conducted in accordance with the study protocol, GCP, and regulatory requirements.
• Ensure accurate, complete, and timely entry of data into clinical trial databases.
• Monitor source documents and compare them against case report forms (CRFs) for discrepancies.
• Manage communication between study sites and the sponsor, addressing any issues or queries promptly.
• Train study site personnel on protocol requirements, study procedures, and data collection.
• Oversee the investigational product accountability and ensure proper storage and handling.
• Prepare site visit reports and follow up on action items with study sites.
• Ensure all essential documents are maintained in the Investigator Site File (ISF) and Trial Master File (TMF).
• Identify and report adverse events (AEs) and serious adverse events (SAEs) according to protocol.
• Contribute to the development of study protocols, CRFs, and other study-related documents.
• Participate in investigator meetings and training sessions.
• Ensure timely submission of all required regulatory documents.
• Maintain strong working relationships with investigators, site staff, and internal project teams.
• Actively participate in the resolution of site-level issues and deviations.
• Report on site performance and identify potential risks or challenges.

• Bachelor's degree in a life science, nursing, pharmacy, or a related scientific field. Advanced degree is a plus.
• Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial monitoring role.
• Thorough understanding of GCP guidelines, ICH regulations, and clinical trial processes.
• Experience with various therapeutic areas is preferred.
• 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 abilities, with attention to detail.
• Ability to travel frequently to clinical trial sites (estimated 50-70% travel).
• Proficiency in English; knowledge of Arabic is an advantage.
• Ability to work independently and as part of a cross-functional team.
• Strong analytical skills and the ability to interpret complex data.

• Recruit, screen, and enroll eligible participants into clinical trials according to protocol requirements.
• Obtain informed consent from participants, ensuring they fully understand the study procedures, risks, and benefits.
• Schedule participant visits, including medical evaluations, laboratory tests, and study-specific procedures.
• Collect, manage, and maintain accurate and complete study data, ensuring compliance with Good Clinical Practice (GCP) guidelines.
• Administer study medications or placebos as per protocol, maintaining meticulous records of administration and inventory.
• Monitor participants for adverse events and report any findings promptly to the principal investigator and regulatory bodies.
• Prepare and maintain all necessary study documentation, including case report forms (CRFs), source documents, and investigational product accountability logs.
• Assist with regulatory submissions and correspondence with Institutional Review Boards (IRBs) and ethics committees.
• Coordinate with external laboratories, pharmacies, and vendors involved in the research study.
• Communicate effectively with the research team, physicians, and study sponsors to ensure seamless trial operations.
• Stay updated on the latest developments in clinical research and relevant therapeutic areas.

• Bachelor's degree in Nursing, Biology, Health Sciences, or a related field.
• Minimum of 3 years of experience as a Clinical Research Coordinator or in a similar research role.
• In-depth knowledge of clinical trial phases, study designs, and regulatory requirements (e.g., ICH-GCP, FDA regulations).
• Experience with electronic data capture (EDC) systems and electronic health records (EHR).
• Excellent organizational, time management, and multitasking abilities.
• Strong communication and interpersonal skills, with the ability to interact empathetically with patients and their families.
• Proficiency in medical terminology and understanding of disease processes relevant to clinical trials.
• Ability to work independently and as part of a collaborative team.
• Attention to detail and a commitment to maintaining data accuracy and integrity.
• Certification from a recognized clinical research professional body (e.g., SoCRA, ACRP) is highly desirable.

• Design and develop clinical trial protocols, ensuring scientific validity and alignment with regulatory requirements.
• Oversee the operational aspects of clinical trials, including site selection, initiation, monitoring, and close-out.
• Collaborate with cross-functional teams, including medical affairs, regulatory affairs, data management, and biostatistics.
• Analyze clinical trial data, interpret results, and prepare comprehensive study reports.
• Contribute to the writing of regulatory submission documents (e.g., INDs, NDAs) and scientific publications.
• Ensure compliance with Good Clinical Practice (GCP), FDA regulations, and other relevant guidelines.
• Manage external collaborations with clinical sites, investigators, and contract research organizations (CROs).
• Develop and present scientific findings at internal meetings and external conferences.
• Stay current with scientific literature, emerging technologies, and therapeutic area advancements.
• Contribute to the strategy and planning of future clinical development programs.
• Ensure the safety and well-being of study participants throughout the trial lifecycle.

• Ph.D. or equivalent doctoral degree in a relevant life science, biomedical science, or related field.
• Minimum of 5 years of experience in clinical research, with a focus on clinical trial design and execution within the pharmaceutical industry.
• Strong understanding of drug development processes, clinical trial phases, and regulatory pathways.
• Proven experience in data analysis, interpretation, and scientific writing.
• Excellent knowledge of GCP, ICH guidelines, and regulatory submission requirements.
• Demonstrated ability to manage complex projects and cross-functional teams.
• Strong analytical, problem-solving, and critical thinking skills.
• Effective communication and presentation skills, with the ability to convey complex scientific information clearly.
• Experience in therapeutic areas such as oncology, immunology, or cardiovascular diseases is highly desirable.
• Ability to work independently and as part of a collaborative team in a fast-paced environment.

• Monitoring clinical trial sites to ensure compliance with protocols, Good Clinical Practice (GCP) guidelines, and applicable regulations.
• Verifying the accuracy, completeness, and consistency of clinical data collected at study sites.
• Ensuring proper documentation, including source documents, case report forms (CRFs), and investigational product accountability.
• Communicating effectively with investigators, site staff, and study sponsors to resolve discrepancies and address issues.
• Conducting site initiation visits, interim monitoring visits, and close-out visits.
• Training site personnel on study procedures, protocols, and data collection requirements.
• Ensuring patient safety and reporting adverse events and serious adverse events promptly.
• Managing study supplies and ensuring proper storage and handling of investigational products.
• Reviewing and reconciling study data, identifying and resolving data queries.
• Participating in the development and finalization of clinical trial documentation, such as protocols and informed consent forms.
• Ensuring compliance with all relevant pharmaceutical industry regulations and ethical guidelines.
• Maintaining organized and up-to-date study files and essential documents.
• Collaborating with internal teams, including data management, regulatory affairs, and project management.
• Reporting on site progress, challenges, and key findings to study management.
• Upholding the highest standards of data integrity and scientific rigor.

• A Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field. A Master's degree is a plus.
• Minimum of 2-3 years of experience as a Clinical Research Associate (CRA) or in a similar clinical trial monitoring role.
• In-depth knowledge of GCP guidelines, ICH regulations, and clinical trial processes.
• Strong understanding of medical terminology and clinical trial methodologies.
• Excellent attention to detail and accuracy in data review and documentation.
• Proficiency in clinical data management software and electronic data capture (EDC) systems.
• Effective communication, interpersonal, and organizational skills.
• Ability to travel to study sites as required.
• Proficiency in both written and spoken English.
• A proactive approach to problem-solving and the ability to work independently.
• Familiarity with the pharmaceutical and healthcare landscape in **Hamad Town, Northern, BH** is beneficial.