Clinical Research Manager

**Position Title**: Clinical Research Manager
**Location**: 700 Swanston Street, Carlton, VIC
**Employment Type**: Part-Time Hybrid (1 day remote, 2 days in-office)
**Reporting to**:CEO
**Desired Start Date**: 1 July 2025 (or sooner if available)

**About Kali Healthcare**

Kali Healthcare is a health technology company dedicated to transforming pregnancy care. Founded by a multidisciplinary team of clinicians and engineers, we develop wearable technologies and digital health tools designed to enhance pregnancy monitoring. Our platform aims to empower clinicians with novel capabilities to detect and manage pregnancy complications and improve access to high quality care for expectant parents.

At Kali Healthcare, creating a better world for mothers, babies and their families is at the heart of everything we do. To achieve this, we foster a culture of high agency, proactive problem solving and respectful collaboration, where every team member’s voice matters.

**About the Role**
Kali Healthcare is looking for a part-time Clinical Research Manager to oversee and manage the execution of clinical research activities across Australia, and other international regions.

As a member of the clinical research team, the Clinical Research Manager will be responsible for the management of clinical studies including planning, coordination, administration, data preparation and reporting.

**Responsibilities**
The Clinical Research Manager will ensure clinical operations run to timeline, budget and comply with regulatory requirements by working as part of Kali’s multidisciplinary research team including the Chief Executive Officer and the Chief Medical Officer.

Key responsibilities include:

- Assist with development of clinical study strategy, including engaging with clinical study sites for set-up of future clinical studies.
- Assist with evidence generation activities including publications, literature reviews, and conference presentations.
- Contribute to the development of clinical study documentation and facilitating implementation at each clinical site
- Assist in preparation of regulatory documentation for the TGA/FDA and co-ordinate usability and human factors studies
- Work with contract research organisations to ensure smooth operation and governance of clinical trials
- Manage clinical trial documentation and administration including coordinating with relevant stakeholders, preparing hospital ethics and research committee (HREC) submissions and reports for successful trial completion
- Assist in data management activities including setting up electronic data capture (EDC) systems, data preparation, maintenance, and entry via paper and electronic case report forms (CRFs)
- Perform protocol-specific clinical trial tasks including tracking patient enrolment, adverse event monitoring and reporting.
- Facilitate quality assurance audits to ensure patient case record accuracy, quality of data and assurance of compliance with protocol.
- Participate in preparing educational materials and providing training to research midwives as needed
- Liaise with clinicians, engineers, and other researchers during clinical trials.

**Desirable Skills**
- Experience in clinical trials relating to a new medical device registration with regulatory bodies, and an interest in the medical device development process
- Must be able to communicate effectively with research scientists, engineers, clinicians, and other staff.
- Must be willing and able to learn new technical skills related to the position in order to perform essential functions of the position (e.g. data management software)
- High agency and a proactive approach to problem-solving.
- Ability to manage multiple concurrent projects in a dynamic startup environment.
- Strong knowledge of GCP, regulatory standards (TGA, FDA), the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research and applicable state/federal privacy laws.

**Essential Qualifications and Other Requirements**
- Graduated from an accredited school/university with a degree in medicine, nursing, midwifery, science or related field
- Minimum of 3 years of industry experience in clinical research management
- Must have Australian citizenship/permanent residence or an appropriate visa with full-time working rights
- Must be located or willing to relocate to Melbourne

**Benefits**
- Competitive salary package + employee share option plan (ESOP)
- Hybrid working arrangement
- Dynamic, collaborative, and creative startup environment

**How to Apply**
1. A detailed CV/resume highlighting your experience in **clinical research management**
2. A brief cover letter explaining your suitability for the role, including **specific examples of relevant achievements