Clinical Study Manager
4 days ago
Unlock Your Potential with Parexel
This is a hybrid position with travel 2/3 days a week to the sponsor's office in the region. As a member of our team, you will play a vital role in the success of our clients, including leading global biotechs and top 50 Pharma companies.
Our Clinical Operations Manager (Regulatory) is responsible for the performance and compliance with assigned protocols in a country, ensuring adherence to ICH/GCP and country regulations, client policies, quality standards, and adverse event reporting requirements.
Key Experience Required:
• Mandatory – Extensive experience in local EC and RA submission, including initial submission and protocol amendments submission.
• Experience in independently preparing submissions to both EC and RA.
• Skilled knowledge of the local regulatory environment, submissions, and approval processes.
• Experience in IMP supplies management at the local level and validation of translated documents.
At Parexel, we value our people and their passion, providing an open and friendly work environment where we empower individuals to develop their long-term careers. You will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments.
About Parexel
Parexel supports clinical studies across the full range of therapeutic areas, with longstanding partnerships with a vast client base. We have supported the trials of most top 50 best-selling drugs and enable more niche drug developments critical to patient well-being.
-
Advanced Clinical Study Report Developer
4 days ago
Bloemfontein, Orange Free State, South Africa IQVIA Full timeIQVIA is seeking a skilled statistical programmer to develop clinical study report materials using the SAS programming language. As a member of our team, you will be responsible for utilizing your programming skills to create high-quality clinical study reports. Responsibilities include:Key Responsibilities:Programming and performing quality control checks...
-
Clinical Operations Manager
2 months ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeAbout the RoleThe Clinical Operations Manager (Regulatory) is a key member of our team at Parexel, responsible for ensuring the successful execution of clinical studies in a country. This role requires a strong understanding of local regulations, submissions, and approval processes, as well as experience in independently preparing submissions to regulatory...
-
Clinical Supply Chain Manager
4 weeks ago
Bloemfontein, Orange Free State, South Africa IQVIA Full timeJob OverviewThe Clinical Supply Chain Manager plays a pivotal role in ensuring the seamless execution of clinical trial supply chain projects. This position requires a strategic thinker who can interpret clinical trial protocols and develop effective supply chain solutions.Key ResponsibilitiesDevelop and execute clinical trial supply chain strategies to meet...
-
Senior Clinical Data Analyst
1 month ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeJob Title: Senior Clinical Data AnalystParexel is seeking a highly skilled Senior Clinical Data Analyst to join our team. As a Senior Clinical Data Analyst, you will be responsible for leading and coordinating clinical data validation activities on assigned projects, with a high degree of proficiency and autonomy.Key Responsibilities:Lead and/or coordinate...
-
Manager of Clinical Operations
4 weeks ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeJoin us in making a difference in clinical research. This position offers a hybrid work model, requiring travel 2 to 3 days a week to the sponsor's office. At Parexel, we provide significant long-term job stability and growth opportunities. We conduct essential clinical trials for sponsors, including leading global biotech firms and top pharmaceutical...
-
Clinical Operations Manager
2 months ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeAbout the RoleWe are seeking a highly skilled Clinical Operations Manager to join our team at Parexel. As a key member of our regulatory team, you will be responsible for ensuring the performance and compliance of assigned protocols in a country, in accordance with ICH/GCP and country regulations, client policies and procedures, quality standards, and...
-
Senior Clinical Data Analyst
3 weeks ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeJob Title: Senior Clinical Data AnalystParexel is seeking a highly skilled Senior Clinical Data Analyst to join our team. As a Senior Clinical Data Analyst, you will be responsible for leading and collaborating with global and cross-functional teams to perform data validation activities, ensuring high-quality data management and compliance with regulatory...
-
Clinical Operations Manager
4 weeks ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeAbout the RoleParexel is seeking a highly skilled Clinical Operations Manager to join our team. As a Clinical Operations Manager, you will be responsible for ensuring the successful execution of clinical trials in a country, in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards, and adverse event reporting...
-
Clinical Data Analyst I
1 month ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeClinical Data Analyst I Job DescriptionParexel is seeking a highly skilled Clinical Data Analyst I to join our team in South Africa. As a Clinical Data Analyst I, you will play a crucial role in ensuring the accuracy and quality of clinical data.Key Responsibilities:Perform data cleaning and data review activities, including query management and manual/SAS...
-
Clinical Operations Manager
1 month ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeAbout the RoleWe are seeking a highly skilled Clinical Operations Manager to join our team at Parexel. As a key member of our regulatory team, you will be responsible for ensuring the performance and compliance of assigned protocols in a country, in accordance with ICH/GCP and country regulations, client policies and procedures, quality standards, and...
-
Clinical Operations Manager
1 month ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeAbout the RoleWe are seeking a highly skilled Clinical Operations Manager to join our team at Parexel. As a key member of our regulatory affairs team, you will be responsible for ensuring the performance and compliance of assigned protocols in a country, in accordance with ICH/GCP and country regulations, client policies and procedures, quality standards,...
-
Clinical Operations Manager
3 weeks ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeAbout the RoleWe are seeking a highly skilled Clinical Operations Manager to join our team at Parexel. As a key member of our regulatory team, you will be responsible for ensuring the performance and compliance of assigned protocols in a country, in accordance with ICH/GCP and country regulations, client policies and procedures, quality standards, and...
-
Clinical Research Associate
1 month ago
Bloemfontein, Orange Free State, South Africa IQVIA Full timeJob Title: Centralized Monitor - Dutch SpeakingWe are seeking a highly skilled and experienced Centralized Monitor to join our team at IQVIA. As a Centralized Monitor, you will play a key role in ensuring the quality and integrity of clinical trials.Key Responsibilities:Perform centralized monitoring activities on assigned projects and evaluate the quality...
-
Senior Clinical Data Analyst
2 weeks ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeAbout the RoleParexel is seeking a highly skilled Senior Clinical Data Analyst to join our team in South Africa. As a key member of our Clinical Data Management team, you will be responsible for leading and coordinating clinical data validation activities on assigned projects.Key ResponsibilitiesLead and/or coordinate all clinical data validation activities...
-
Clinical Operations Manager
4 weeks ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeAbout the RoleWe are seeking a highly skilled Clinical Operations Manager to join our team at Parexel. As a key member of our regulatory team, you will be responsible for ensuring the performance and compliance of assigned protocols in a country, in accordance with ICH/GCP and country regulations, client policies and procedures, quality standards, and...
-
Clinical Research Associate
2 weeks ago
Bloemfontein, Orange Free State, South Africa IQVIA Full timeJob Title: Centralized Monitor - Dutch SpeakingAre you a detail-oriented and results-driven individual with excellent communication skills and a passion for clinical research?We are seeking a Centralized Monitor - Dutch Speaking to join our team at IQVIA. As a Centralized Monitor, you will be responsible for providing remote project support and assistance...
-
Data Management Specialist
6 days ago
Bloemfontein, Orange Free State, South Africa Staff Unlimited Recruitment Full timeOur client, a specialized Contract Research Organization (CRO), is seeking a Data Management Specialist to join their team for a Clinical Research position. This role is responsible for maintaining and constantly improving performance and quality in data management services.Key Responsibilities:CRF tracking, set-up, and testing of databases for paper and...
-
Senior Clinical Data Analyst
4 days ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeParexel is currently recruiting for a Senior Clinical Data Analyst in South Africa.This role involves independently performing and/or coordinating all clinical data validation activities on assigned projects, with a high degree of proficiency and autonomy. Key responsibilities include providing technical expertise and/or operational leadership regarding all...
-
Clinical Data Analyst II
1 month ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeClinical Data Analyst II Job DescriptionParexel is seeking a highly skilled Clinical Data Analyst II to join our team in South Africa.Key Responsibilities:Perform clinical data validation activities on assigned projects with minimal guidance and supervision.Support data validation activities, data management documents, and data cleaning matrices.Act as a...
-
Clinical Operations Manager
1 month ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeAbout the RoleWe are seeking a highly skilled Clinical Operations Manager to join our team at Parexel. As a key member of our regulatory team, you will be responsible for ensuring the performance and compliance of assigned protocols in a country, in accordance with ICH/GCP and country regulations, client policies and procedures, quality standards, and...