82 Clinical Affairs jobs in Bahrain

Pharmaceutical Regulatory Affairs Manager

123 Riffa, Southern BHD4800 month WhatJobs

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full-time
Our client, a leading pharmaceutical company, is seeking a highly qualified and experienced Pharmaceutical Regulatory Affairs Manager to oversee regulatory compliance and submissions for their product portfolio in Riffa, Southern, BH . This critical role ensures that all products meet the stringent requirements of local and international health authorities. The ideal candidate will possess a deep understanding of pharmaceutical regulations, excellent analytical skills, and a meticulous approach to documentation and compliance. Key responsibilities include developing and implementing regulatory strategies, preparing and submitting regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities, and managing post-approval regulatory activities. You will also stay abreast of evolving regulatory landscapes, provide regulatory guidance to internal teams (R&D, manufacturing, marketing), and liaise with regulatory agencies. Experience in managing regulatory affairs for generic and/or innovator pharmaceuticals is essential. A proven track record in successfully navigating regulatory approval processes is required. A minimum of 6 years of experience in pharmaceutical regulatory affairs is mandatory. A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field is required; a Master's or PhD is advantageous. Fluency in English and excellent written and verbal communication skills are essential. Familiarity with GMP, GLP, and GCP is also important. This role offers a significant opportunity to contribute to bringing vital pharmaceutical products to market in compliance with all necessary regulations.
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Regulatory Affairs Executive & Warehouse Pharmacist

Manama, Capital Zahrawi Group

Posted 5 days ago

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Job Description

Regulatory Affairs Executive & Warehouse Pharmacist - (484) About Zahrawi Group

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.

Job Brief

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.
REQUIREMENTS
  • 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.
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Clinical Research Associate

70130 Amwaj Islands BHD4500 Annually WhatJobs

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Job Description

full-time
Our client, a leading pharmaceutical organization, is actively seeking a meticulous and driven Clinical Research Associate (CRA) to join their dedicated team in **Isa Town, Southern, BH**. This vital role is responsible for monitoring and managing clinical trials to ensure adherence to protocols, good clinical practice (GCP) guidelines, and all applicable regulatory requirements. The successful candidate will play a key role in the successful execution of clinical studies, contributing to the development of life-saving medications.

Responsibilities:
  • 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.
Qualifications:
  • 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.
This is a critical role for an experienced CRA looking to make a significant impact in pharmaceutical research.
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Clinical Research Associate

80610 Al Markh BHD75000 Annually WhatJobs

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full-time
Our client is recruiting a dedicated and meticulous Clinical Research Associate (CRA) to support their clinical trial activities in Sanad, Capital, BH . This vital role ensures that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP) guidelines. The CRA will be responsible for monitoring clinical trial sites, verifying data accuracy and integrity, and ensuring patient safety. You will conduct site initiation visits, routine monitoring visits, and close-out visits, as well as essential document management. Key responsibilities include managing investigational product accountability, resolving data queries, and ensuring compliance with all regulatory requirements. Building and maintaining strong relationships with investigators and site staff is paramount. The ideal candidate will possess a Bachelor's degree in a life science or healthcare-related field, with at least 3 years of experience as a Clinical Research Associate. Thorough understanding of ICH-GCP, clinical trial processes, and regulatory requirements is essential. Strong organizational, communication, and problem-solving skills are required. The ability to travel to clinical trial sites is a prerequisite. This is an exciting opportunity to contribute to groundbreaking medical research and help bring new therapies to patients.
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Clinical Research Associate

1005 BH Bilad Al Qadeem, Capital BHD65000 Annually WhatJobs

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full-time
Our client, a leading pharmaceutical innovator, is looking for an experienced Clinical Research Associate to join their expanding team in Manama, Capital, BH . This role is critical in supporting the execution of clinical trials, ensuring compliance with all relevant regulations and protocols, and contributing to the development of life-saving medications. The Clinical Research Associate will be responsible for site monitoring, data collection and verification, and maintaining accurate trial documentation. Key duties include identifying and qualifying study sites, training site staff, ensuring adherence to Good Clinical Practice (GCP) guidelines, and resolving data discrepancies. You will work closely with investigators, study coordinators, and internal project teams to facilitate the smooth running of trials and ensure patient safety and data integrity. This position requires a meticulous approach, strong organizational skills, and the ability to manage multiple tasks efficiently. The successful candidate will possess a Bachelor’s degree in a life science, nursing, or a related field, coupled with significant experience in clinical research. A thorough understanding of pharmaceutical industry standards, regulatory affairs, and clinical trial processes is essential. Excellent communication and problem-solving skills are a must. Travel to clinical sites will be required as needed. This is an exciting opportunity to be part of a forward-thinking company dedicated to advancing healthcare and to contribute to groundbreaking research in the heart of Manama.
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Clinical Research Coordinator

101 Riffa, Southern BHD60000 Annually WhatJobs

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full-time
Our client, a respected community healthcare provider in Riffa, Southern, BH , is seeking a dedicated and detail-oriented Clinical Research Coordinator to join their dynamic team. This role is crucial in facilitating the smooth execution of clinical trials, ensuring patient safety, data integrity, and adherence to regulatory guidelines. The successful candidate will work closely with physicians, patients, and research sponsors to manage all aspects of clinical research studies.

Responsibilities:
  • 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.
Qualifications:
  • 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.
Join our team in Riffa, Southern, BH and make a significant contribution to advancing medical knowledge and patient care through innovative clinical research.
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Clinical Research Scientist

10256 Busaiteen, Muharraq BHD75000 Annually WhatJobs

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full-time
Our client, a leading pharmaceutical research and development company situated in Busaiteen, Muharraq, BH , is seeking a highly skilled and dedicated Clinical Research Scientist. This role is critical to advancing our pipeline of innovative therapeutics through meticulous planning, execution, and analysis of clinical trials. The ideal candidate will possess a strong scientific background, extensive experience in clinical research methodologies, and a commitment to upholding the highest standards of data integrity and regulatory compliance. You will contribute to groundbreaking studies that have the potential to transform patient care.

Responsibilities:
  • 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.
Qualifications:
  • 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.
This is an outstanding opportunity to contribute to cutting-edge pharmaceutical research in a supportive and intellectually stimulating environment.
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Clinical Research Associate

1022 Tubli, Central BHD68000 Annually WhatJobs

Posted 1 day ago

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full-time
Our client is actively seeking a dedicated and meticulous Clinical Research Associate (CRA) to join their growing pharmaceutical division in **Budaiya, Northern, BH**. This vital role involves supporting and managing clinical trials, ensuring adherence to protocols, and upholding the highest standards of data integrity and patient safety. The ideal candidate will be detail-oriented, possess strong organizational skills, and have a deep understanding of pharmaceutical research processes.

Primary responsibilities include site selection, initiation, monitoring, and closing of clinical trial sites. You will be responsible for ensuring that clinical trials are conducted, recorded, and reported in accordance with the trial protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and other applicable regulatory requirements. This involves performing source data verification, reviewing study documentation, and ensuring accurate and timely data entry into clinical databases. The CRA will also liaise with investigators and site staff, address protocol deviations, and manage investigational product. Additionally, you will be responsible for preparing for and participating in regulatory inspections and audits.

Qualifications required include a Bachelor's degree in a life science, nursing, or a related field. A Master's degree is an advantage. Prior experience as a CRA or in a similar role within the pharmaceutical or biotechnology industry is essential, preferably with experience in Phase II or III trials. A thorough understanding of ICH-GCP guidelines and regulatory requirements is mandatory. Excellent communication, interpersonal, and problem-solving skills are necessary. The ability to travel to clinical sites (approximately 50-60%) is required. Strong computer skills, including proficiency with clinical trial management systems and electronic data capture (EDC) systems, are important. This is an exceptional opportunity to contribute to the development of life-saving medications and advance your career in clinical research.
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Clinical Research Associate

1152 Hamad Town, Northern BHD1500 month WhatJobs

Posted 5 days ago

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full-time
Our client, a dynamic pharmaceutical company dedicated to advancing healthcare, is seeking a meticulous and driven Clinical Research Associate to join their team in **Hamad Town, Northern, BH**. This vital role supports the execution of clinical trials, ensuring adherence to protocols, regulations, and ethical standards. The ideal candidate will possess a strong scientific background and experience in clinical trial management. Key responsibilities include:
  • 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.
Qualifications:
  • 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.
This position offers a competitive salary, benefits, and the chance to contribute to the development of life-saving medications.
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Clinical Research Associate

205 Durrat Al Bahrain BHD70000 Annually WhatJobs

Posted 5 days ago

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full-time
Our client, a leading pharmaceutical innovator, is searching for a meticulous and dedicated Clinical Research Associate (CRA) to join their team in Jidhafs, Capital, BH . This role is pivotal in ensuring the successful execution of clinical trials, adhering strictly to Good Clinical Practice (GCP) guidelines and regulatory requirements. The CRA will be responsible for monitoring study sites, verifying the accuracy and completeness of data, ensuring patient safety, and managing the overall conduct of trials. Key responsibilities include site initiation visits, routine monitoring visits (on-site and remote), data review and query resolution, and close-out visits. You will serve as the primary liaison between the sponsor and the investigative sites, fostering strong working relationships with principal investigators and study staff.

The ideal candidate will possess a Bachelor's degree in a life science, nursing, or a related field, coupled with demonstrable experience as a CRA or in a similar clinical research role. A thorough understanding of ICH-GCP guidelines, clinical trial protocols, and regulatory affairs is essential. Strong organizational skills, excellent attention to detail, and the ability to manage multiple tasks and priorities effectively are critical. The candidate must possess outstanding interpersonal and communication skills, with the ability to build rapport and influence stakeholders at all levels. Proficiency in clinical trial management software and electronic data capture (EDC) systems is a significant advantage. This position involves frequent travel to clinical trial sites, requiring flexibility and a valid driver's license. Our client offers a competitive compensation package, comprehensive benefits, and ample opportunities for professional growth and development within the pharmaceutical industry. If you are passionate about advancing medical treatments and ensuring the highest standards in clinical research, this is the role for you. Join us in making a difference in patient lives through rigorous scientific investigation.
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