Post Graduate Diploma in Clinical Operations

Next start date: June 2023 | Fee: $5,000 

Introduction

This diploma delivered by FCD in partnership with UWC and covers the core topics one must know to manage research sites and lead clinical trials.

The main main focus of this diploma is on the successful operation of clinical trials and research sites within the context of the ethical, regulatory and economic environments all clinical research must operate in.

Graduates will learn many skills making them valuable members of any clinical trial. The diploma will give learners an overall understanding of the clinical trial process from project management to research design and protocol development. Best practices for patient recruitment and retention will be explored as well as data management, data monitoring, pharmacovigilance, safety reporting and good financial practices. Graduates will be able to help design and maintain the quality system of a clinical research site, and audits and inspections.

The graduate of this post graduate diploma will typically work at a clinical research site, hospital, CRO or pharmaceutical company. The student may be a physician, nurse, pharmacist, scientist or member of staff already working in clinical development or is someone who wishes to transition into a role in this area and wishes to gain a thorough grounding in the key topics they are expected to contribute towards.

Why Study this Program?

Enhance your career opportunities in an area where there is a great need for qualified professionals

Gain the skills to be a valuable contributor during the clinical development of medicines that meet unmet medical needs.

Learn to apply evidence-based thinking to a range of challenges those working in clinical operations must resolve

Learn from renowned world leading experts in a area in high demand,

Award Title
Post Graduate Diploma

Program Duration
12 Months

In Partnership with
University of Western Cape

Entry Requirements

Applicants with any of the following qualifications may be considered for acceptance:

Four-year degree in pharmacy – [e.g., BPharm or BSc (Pharm)].

Degree in medicine or allied discipline.

Three or four-year degree in science (e.g., BSc Hons).

Three or four-year degree in a non-scientific subject plus one years’ relevant work experience.

Post Graduate Certificate in Regulatory Affairs delivered by FCD in partnership with UWC plus two years’ relevant work experience.

Post Graduate Certificate in Clinical Operations delivered by FCD in partnership with UWC plus two years’ relevant work experience.

Post Graduate Certificate in Ethics and Leadershipdelivered by FCD in partnership with UWC plus two years’ relevant work experience.

Applicants without these qualifications may be considered if they can show suitable motivation and a high potential to positively contribute to the course. Consideration will be based on academic merit and appropriate experience.

What will I Study?

This 12-month online Post Graduate Diploma blends self-directed study with Tutor-led team-based learning. Throughout the course, you’ll engage in:

State of the art teaching via on-demand interactive lectures.

Learning through real world case studies, online group tutorials and team work.

Assessments that directly simulate the challenges faced by regulators and allied professions, for example clinical development and medical affairs. 

Modules

This program consists of the following modules.

Ethics

Clinical Research Operations

Generics & Biosimilars

Regulatory Affairs

Clinical Trial Mgt. & Stats

Health Economics

Leadership & Negotiation

Program Benefits

Graduates will receive a Post Graduate Diploma delivered by FCD in partnership with the University of the Western Cape a world leading, research-led, learning and teaching university with a legacy of social justice, community engagement and graduate employability.

Designed and delivered by leading experts with a global perspective

You can study while balancing existing family and work commitments

No need to travel as the program is online, available anytime, anywhere, on any device.

Possible path to the M.Sc. in Pharmacy Administration and Regulatory Policy for those who do not meet normal entry criteria.

If you are accepted onto the M.Sc in Pharmacy Administration and Policy Regulation after completing this diploma you may be eligible for exemptions worth up to 70 South African credits. The M.Sc is a 180 South African credit program. This is subject to availability and a final decision by UWC.

Post Graduate Diploma in Clinical Operations
Post Graduate Diploma in Clinical Operations