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Job Source: Eq-fin BryanstonEq-fin Bryanston
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Job Source: Eq-fin BryanstonJohannesburg, Gauteng
R 400000 ZA Per annum
Job Description:
Lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model.
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Job Responsibilities:
Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.
Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant AZ SOPs and local regulations.
Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
Ensures timely preparation of country financial Study Management Agreement (f SMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.
Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
Job Requirements:
Excellent understanding of the Clinical Study Process including monitoring.
Good knowledge of the Drug Development Process.
Excellent ability to prioritize and handle multiple tasks.
Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
Ability to travel nationally and internationally as required.
Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
Excellent team building and interpersonal skills.
Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
Good ability to learn and to adapt to work with IT systems.
Excellent project management skills.
Minimum 3 years of experience in Development Operations (CRA, Sr CRA) or other related fields (Medical Affairs-led or Academic-led studies).
Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*).
Job Details:
Company: Astra Zeneca
Vacancy Type: Full Time
Job Location: Johannesburg
Application Deadline: N/A
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Analytical chemistry jobs pretoria – local study associate director jobs in Johannesburg, Gauteng
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