Clinical Trials Manager

**Main purpose of the job**:

- Ensure compliant, timely, and cost-efficient delivery of clinical projects across a portfolio through technical input and ongoing review and evaluation of project performance, in collaboration with project teams

**Location**:

- **Ezintsha - 32 Princess of Wales Terrace, Parktown - Johannesburg**

**Key performance areas**:

- Provide senior review and advice to prepare regulatory submissions and ensure high-quality standards that meet or exceed expectations and national requirements
- Provides up-to-date legislation and guidance as it becomes available
- Manage and coordinate core file reviews and audits as needed
- Drive eTrial Master File (eTMF) filing compliance focusing on completeness, timeliness, and quality
- Ensure quality performance for managed projects
- Identify and recognize out-of-scope activities in a contract in a timely manner and liaise with other departments to follow through on all aspects of contract modifications
- Ensure compliance with relevant organizational SOPs and regulatory standards
- Establish and manage performance dashboards, analyze event triggers/alerts and determine appropriate follow-up for Study teams
- Coordinate project schedule and ensure timely updates of all key milestones and partner with study team on related calls
- Develop and maintain relevant sections of Project Management Plans
- Prepare project status reports and presentation materials for internal project teams and stakeholder meetings in collaboration with study teams
- Monitor project metrics and make required updates to ensure accurate and timely reporting is available to senior management, project teams, and external stakeholders as applicable
- Ensure portfolio heads have timely and accurate data on areas including cost, schedule, scope, utilization, and change orders to support better decision-making
- Review and support project resource allocation within project budgets for assigned portfolios/projects
- Develop direct reporting staff to ensure they have the skills required by the organization and are able to achieve their performance objectives
- Responsible for human resources management to ensure optimal staff utilization and maintenance of sound labor relations
- Support the development of a work schedule and process flow for line reports to guide their activities
- Promote harmony, teamwork, and sharing of information
- Take ownership and accountability for tasks & activities and demonstrates effective self-management
- Inform relevant parties in the event of tasks or deadlines not being met and provide appropriate means of resolution
- Support and drives the business’ core values
- Maintain a positive attitude
- Take ownership of own career development

**Required minimum education and training**:

- **Graduate Degree in Science, Allied medical sciences, or related Degree**

**Required minimum work experience**:

- **Minimum of 5 years of clinical trials experience with sound regulatory affairs expertise and managerial experience**

**Desirable additional education, work experience, and personal abilities**:

- Post Graduate qualification in Project and Financial Management
- Portfolio management experience
- Demanding stakeholders (i.e. project teams, funders, and collaborators)
- Maintain confidentiality and diplomacy
- Methodical and systematic
- Agility, adaptability, and innovativeness

**TO APPLY**:

- Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
- _AJ Personnel is fully POPIA Compliant._
- Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.

**Please note**:

- **Our Client, WHC - Ezintsha, maintains mandatory Covid-19 requirements, and as such only Covid-19 vaccinated incumbents will be considered for positions.**:

- WHC, in accordance with its Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.
- AJ Personnel is only responsible for advertising the advertisement on behalf of their client Wits Health Consortium.
- AJ Personnel does not have any salary or other information regarding the position.