Cra Manager

** CRA Manager**
- **Permanent full-time** role with **competitive renumeration and benefits**:

- ** Location**: Macquarie Park Office, NSW
- ** Travel**: 20-30%
- ** Manage and support** an agile and **passionate** team of CRA’s**:

- ** Upskill and growth in an area you’re passionate about,** whilst being fully **supported and encouraged**

This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Head of Site Management and Monitoring, 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 continuously develop key talents by providing training, support and mentoring to the CRAs and properly manage situation of low or non-performance. The role will work at country level with other local stakeholder e.g. CRM and COM Leads to ensure alignment and development of the country capabilities. The role will collaborate with country PLMs to ensure alignment across all monitoring functions. The person contributes to HQ capacity/resource planning activities to ensure efficient allocation of resources and work.

**What You Will Do**

**Responsibilities include, however not limited to**:

- Work allocation, staff development and performance appraisal.
- Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources.
- Work with CRAs, PLMS and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.
- Interacts with sites as needed to resolve site or CRA operational issues to meet commitments in a timely manner in coordination with the study CRM.
- Attend local Investigator Meetings if requested to.
- Interface with GCTO partners on clinical trial execution.
- Escalates site performance issues to HSMM, Clinical Research Director CRD and other relevant stakeholders.

**People and Resource Management**:

- Manage CRA - career development, performance reviews, and including addressing low performance situations and taking appropriate actions.
- Support and resolve escalation of issues from CRAs.
- Liaise with local HR and finance functions as required.
- Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work.
- Manage local conflicts between resource and work.
- Provides training, support and mentoring to the CRA to ensure continuous development.
- Ensures CRA compliance to corporate policies, procedures and quality standards.

**CORE Competency Expectations**:

- Ability to work independently and in a team environment.
- Excellent people management, time management, project management and organizational skills.
- History of strong performance.
- Skills and judgment required to be a good steward/decision maker for the company.
- Fluent in Local Language and business proficient in English (verbal and written).
- Excellent working knowledge of all applicable ICH/GCP regulations and good documentation practices, and ability to work within these guidelines.
- Expertise in and excellent working knowledge of core trial management systems and tools.

**Behavioural Competency Expectations**:

- High emotional intelligence
- Strong leadership skills with proven success in people management
- Excellent interpersonal and communication skills, conflict management
- Demonstrated ability to build relationships and to communicate effectively with external customers (e.g. sites and investigators)
- Influencing skills

**What You Must have**
- Bachelor’s degree in Science
- Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology, preferred
- Solid prior experience within Clinical Research
- Prior experience as CRA monitoring clinical trials
- Line management experience preferred or at the minimum team leader experience

**What You Can Expect**
- ** Work autonomously whilst being supported, encouraged**:

- Exposure to **upskill and develop**

**Excluded**:

- No relocation offered
- No VISA sponsorship available

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Not Applicable

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Job Posting End Date**:
01/22/2025

**Requisition ID**:R327423