Job Openings at Clintec

Job description

Clintec is actively recruiting for a Medical Monitor to join our expanding global company in South Africa. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.

Role Description

The Medical Monitor will have responsibilities to ensure the safety of subjects participating in Clinical Trials. The Medical Monitor will be expected to take appropriate actions as are delegated to ensure the timely and quality performance of clinical trials, collection of data and completion of Study Reports for assigned projects.

Responsibilities Of The Medical Monitor

• Providing Medical Leadership to the monitoring staff in the region
• Developing and maintaining expertise in the compounds under development and their related fields
• Monitoring the safety of subjects participating in the Clinical Trials
• Selection of Clinical Investigators
• Handling Serious Adverse Event Reports in accordance with the SOPs
• Ensuring timely distribution of IND reports to investigators and EC
• Review and agreement of study budgets with the sites
• Review of the site monitoring reports for safety
• Supporting the CRAs in ensuring that sites conform to GCP and SOPs
• Participating in internal study team meetings
• To participate in the training of the department staff

Essential Criteria

• Practical experience as a Physician within a hospital environment
• Medical Doctor Degree
• Clinical Trials monitoring experience
• Knowledge of Clinical Trial Regulations in the countries of the Region
• Knowledge of Clinical Trial methodology and design
• Thorough understanding of the protocol, ICH-GCP, ICF and SOPs
• Excellent communication skills and the ability to work both independently and in the team
• Fluency in English (both written and spoken)
• Good computer skills

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Job description

Clintec is currently recruiting a number of Clinical Scientists to join our growing team in South Africa. These positions are full time and Office based. The successful candidate should be willing to work remotely, but travel to our sponsor offices as required (<5% travel). By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.

Responsibilities Of The Clinical Scientist

• Coordinating /supporting the scientific conduct of a clinical protocol
• Assists the Program Lead and study team with the scientific conduct of clinical studies
• May have specific task assignments for a single study or across multiple studies, e.g, adjudication support, medical monitoring, data management deliverables, preparation of meeting materials, safety and medical monitoring.
• May interact with internal and external stakeholders (study sites, committees, etc) in support of clinical study objectives.
• Expertise of the Protocol on multifunctional teams (w orking with data management, clinical supplies, statisticians, clinical directors, study start up specialists, Operational leads, ancillary supplies, medical writers)
• Train and answer any Protocol questions from the field including CRAs and sites
• Respond to ethic committee and IRB questions regarding the study
• Work with the clinical director to answer any medical questions from the field
• Lead medical monitoring activities
• Lead DMC or scientific expert committee meetings along with the clinical director
• Lead safety teleconferences with sites for Phase I/II studies.

Essential Criteria

• Degree in the Life Science
• Bachelor’s degree with 4+ years’; or MS with 3+ years’ relevant career experience
• Pharmaceutical and/or clinical drug development experience
• Demonstrated oral and written communication and computer/database management skills
• Ability to work remotely in South Africa
• Ability to travel to sponsor offices
• Fluency in English