Executive Director, Clinical Research SA
2 months ago
As the Executive Director of Clinical Research, the individual will lead Clinical Operations for South Africa and the Sub-Saharan Cluster, overseeing all Clinical Trials. They will play a crucial role in shaping the clinical research landscape by representing the organization to Regulators, Research Institutions, and Industry Associations. As part of the EMEA Clinical Operations leadership team, they will help design and implement regional strategies and participate in various internal forums.
In this leadership position, the Executive Director will foster a compliant, collaborative, and innovation-driven work environment, managing a team of Directors and Associate Directors responsible for South Africa. They will ensure trial quality, handle audit/inspection responses, and complete corrective and preventive actions (CAPAs). Serving as the single point of contact, they will oversee clinical trial execution across phases I/II through III/IV in the cluster and engage with Global Clinical Trials Organization and Research and Development teams in the US, along with vital interactions with Quality Assurance, Finance, Regulatory, Clinical Supplies, Legal, Global Medical Affairs, and European Clinical Development.
The Executive Director will ensure compliance with GCP and local/global policies, conducting high-quality, inspection-ready studies while being accountable for trial quality, audit responses, and CAPA completion within the Global Clinical Trial Operations framework.
Responsibilities:
- Lead the South African and Sub-Saharan Cluster Clinical Trial Operations leadership team, leading strategic development to deliver clinical trials as per their growing global clinical research pipeline requirement
- Be the strategic country and cluster representative for initiatives at all levels of the organization
- Build and lead the team to effectively manage resources, ensuring appropriately skilled and high-performing teams to effectively deliver the study portfolio across their therapy areas to achieve on their objectives
- Lead the strategic development and management of institutional & investigator relationships in conjunction with the company’s research division’s Therapy Areas
- Work with their regional and global colleagues, developing and executing the Clinical Trial Operations strategy for South Africa and cluster - such as Industry associations
- Recruit, hire, proactively manage and develop talent – in addition to creating an empowering, compliant, collaborative, and innovation-focused work environment
- Proactively identify new opportunities and gaps to support emerging needs and addresses them by reallocating and training of existing staff and/or external recruitment
- Build a culture of quality and compliance through training, oversight, and collaboration
- Oversight to ensure appropriate scientific and operational training for staff members
- Clinical Trial Operations and Research division’s goals, initiatives and expectations
- Development and delivery of company standards
- Activities of all cluster-level teams, programs and studies
- Country-level operational study budgets
- Regulatory Inspections and internal audits; responding to inquiries by health authorities, ethics committees, and internal auditors, compliance, Regulatory, Pharmacovigilance (PV) and Medical Affairs
- Responsible and supports the development of audit responses and completion of CAPAs
- Functional Service Provider (FSP): Senior, Regional and local Leadership to ensure adequate and appropriate resourcing for company's internal clinical trial portfolio
- Support the development and management of Investigator and operational relationships in conjunction with all research division’s Therapy Areas, and when appropriate – Human Health colleagues
- Contribute to the program life-cycle management through effective study allocation and execution (prioritising programs, working with Key Opinion Leaders etc.)
- Drive change by shaping the external environment
- Ensure that compliance, quality and timeline objectives are met for all trials executed in the cluster
- Sets clear performance standards and holds self and organisation accountable for achieving results
- Work collaboratively in a matrix organisation with all groups within Clinical Trials, especially with Clinical Sciences and Study Management in their US headquarters, Clinical Quality Managers and Regional Operations Teams, to deliver objectives
- Take responsibility for any clinical audits, working closely with the Quality Assurance (QA) group and the Good Clinical Practice Quality and Compliance Council
- Bachelor’s degree in Science or equivalent healthcare experience is required, advanced degree, (e.g., MD, PhD, Pharm D, MS, MBA) is preferred
- Significant experience in Clinical Trials
- Proven leadership experience, preferably in the pharmaceutical or biotech company
- Significant Management experience in a Clinical Trials setting with the ability to service and collaborate with different stakeholders in a matrix organization.
- Strategic thinking
- Management expertise should cover management of budget, travel, resources, headcount, processes (and controls), productivity, quality and project delivery
- A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required.
- Strong Communication skills requiring proficiency in written and spoken English. The incumbent must be competent and effective in written and verbal communication
- High emotional intelligence
- Strong leadership that will attract, motivate, inspire, develop and retain talented staff. In addition, Leadership skills that enable and drive alignment with the goals, purpose and mission of the company
- Positive proven success in people management
Should you not receive feedback within 7 days, please accept your application as unsuccessful
-
Clinical Research Director
4 weeks ago
Midrand, Gauteng, South Africa MNA Recruitment (Pty) Ltd Full timeClinical Research Director**Job Summary**MNA Recruitment (Pty) Ltd is seeking an experienced Clinical Research Director to lead Clinical Operations for South Africa and the Sub-Saharan Cluster. The ideal candidate will have a strong background in clinical trials, excellent leadership skills, and the ability to shape the clinical research landscape.**Key...
-
Executive Director, Clinical Research South Africa
2 months ago
Midrand, South Africa MSD Full timeJoin our cutting-edge Clinical Research team that is dedicated to enhancing global healthcare through groundbreaking research and innovation. As the **Executive Director of Clinical Research**, you will spearhead Clinical Operations in **South Africa and the Sub-Saharan Cluster**, overseeing the execution of all clinical trials within the region. You will...
-
Clinical Research Director
3 weeks ago
Midrand, Gauteng, South Africa MNA Recruitment (Pty) Ltd Full time**Job Title:** Clinical Research Director**About the Role:** MNA Recruitment (Pty) Ltd is seeking a highly skilled Clinical Research Director to lead Clinical Operations for South Africa and the Sub-Saharan Cluster.The ideal candidate will have a deep understanding of clinical trials and a proven track record of leadership in the pharmaceutical...
-
Associate Clinical Research Manager
5 months ago
Midrand, South Africa MSD Full timeWith support of other Clinical Research Managers and/or Therapeutic Area Head/Clinical Research Director, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting...
-
Clinical Research Manager
6 months ago
Midrand, South Africa MSD Full timeThis role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the Clinical Research Manager could be...
-
Clinical Research Manager
2 months ago
Midrand, South Africa MSD Full timeThis role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the Clinical Research Manager could be...
-
Clinical Research Manager
5 months ago
Midrand, South Africa MSD Full timeThis role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the Clinical Research Manager could be...
-
Sr. Clinical Research Associate
5 months ago
Midrand, South Africa MSD Full timeThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or Clinical Research Director, the person ensures compliance of study conduct with ICH/Good Clinical Practice and country regulations, our company's policies and procedures, quality standards and adverse event reporting...
-
Clinical Research Associate Manager
5 months ago
Midrand, South Africa MSD Full timeThis role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Clinical Research Director (CRD) the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP. As line manager the role is critical to...
-
Clinical Research Associate
5 months ago
Midrand, South Africa MSD Full timeThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA Manager, the person ensures compliance of study conduct with Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and...
-
Clinical Research Associate
5 months ago
Midrand, South Africa MSD Full time**Brief Description of Position** The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, the organization's policies and procedures, quality standards and adverse event reporting...
-
Sr. Clinical Research Associate
5 months ago
Midrand, South Africa MSD Full time**Brief Description of Position** The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, organizational policies and procedures, quality standards and adverse event reporting...
-
Executive Personal Assistant
5 months ago
Midrand, South Africa Kontak Recruitment SA Full timeMidrand, Gauteng - Administrative **Executive Personal Assistant (JB4057)** Midrand, Gauteng R20 000 to R22 000 a month CTC Permanent A premier transportation service provider in multiple cities offering 24/7 door-to-door services for travellers is looking for a professional Executive Personal Assistant to join their Team. Their luxury vehicles and expert...
-
Clinical Operations Manager
5 months ago
Midrand, South Africa MSD Full timeThis role is accountable for performance and compliance for assigned protocols in South Africa and Other African Countries in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the COM lead, Head COMs or CRD, you...
-
Associate Clinical Research Associate
5 months ago
Midrand, South Africa MSD Full time**Brief Description of Position** With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical...
-
Clinical Operations Manager
5 months ago
Midrand, South Africa Edge Executive Search Full timeAre you a dynamic leader with a passion for driving excellence in healthcare operations? Look no further! our client is seeking a talented individual to fill the crucial role of **Clinical Operations Manager.** As part of the dedicated team, you'll play a pivotal role in driving and implementing clinical operations functions across the dialysis units,...
-
Sales Director for Renewable Energy
5 months ago
Midrand, South Africa Hexing Electrical SA (Pty) Ltd Full time**JOB DESCRIPTION** **Job Title**: Sales Director for Renewable **Location**:Midrand, Gauteng Energy **Salary**: Negotiable **Department**: Sales **Working Hours**:08h30 - 17h30 **Job Objective**: The successful Sales Directors will oversee the Livoltek sales team to ensure they meet sales targets. They will be responsible for leading and motivating...
-
Clinical Trial Coordinator
5 months ago
Midrand, South Africa MSD Full time**Brief Description of Position**: Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools,...
-
Sales Director for Electricity Meters
5 months ago
Midrand, South Africa Hexing Electrical SA (Pty) Ltd Full time**JOB DESCRIPTION** **Job Title**: Sales Director for Electrical **Location**:Midrand, Gauteng Meters **Salary**:Negotiable **Department**: Sales **Working Hours**:08h30 - 17h30 **Job Objective**: The successful Sales Directors will oversee the Hexing Electrical sales team to ensure they meet sales targets. They will be responsible for leading and...
-
Researcher
5 months ago
Midrand, South Africa Source and Select Full time**Unlock Your Research Potential at Productivity SA!** Are you a passionate economist with a knack for uncovering insights that drive economic growth? Productivity SA is on the hunt for a dedicated Researcher to join our pioneering team and be at the forefront of shaping a more productive and competitive future! **More About Us**: Productivity SA is a...
