Cra Manager for New Zealand

Opportunity to join a leading global biopharma company
- Exciting chance to work with passionate and collaborative teams
- Be at the center of innovation and excellence in execution.

Our Clinical Research and Pharmacovigilance team pushes global healthcare boundaries through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

In this role, you will be critical to ensure strong monitoring in our clinical trials. Under the oversight of the Head of Site Management and Monitoring and a dotted line to the NZ CRD, you will be responsible for managing a team of 6-14 CRAs and ensuring excellent study and site performance with strict adherence to local regulations, company SOPs, and ICH GCP.

As a line manager, you will be critical to continuously developing key talents by providing training, support, and mentoring to the CRAs and properly managing situations of low or non-performance.

You will work at the country level with other local stakeholders to ensure alignment and development of the country's capabilities. You will collaborate with country PLMs to ensure alignment across all monitoring functions. You will contribute to HQ capacity/resource planning activities to ensure the efficient allocation of resources and work.

**What will you do**:

- Work allocation, staff development and performance appraisal.
- Provides input for capacity planning, including reporting current workforce and forecasting 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 promptly in coordination with the study CRM.
- Attend local Investigator Meetings if requested. Interface with GCTO partners on clinical trial execution.

Escalates site performance issues to CRM and Clinical Research Director CRD.

**People and Resource Management**:

- Manage CRA - career development, performance reviews, etc., addressing 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 efficiency:

- Allocation of resources and work. Manage local conflicts between resources and work.Provides training, support, and mentoring to the CRA to ensure continuous
- development.
- Ensures CRA compliance to corporate policies, procedures and quality standards

**What should you have**:

- Bachelor's degree in science. Advanced degree (e.g. BA/BS or higher) with a strong emphasis in science and biology is preferred. Minimum of 5 years' experience in Clinical Research
- with at least three years' experience as CRA monitoring clinical trials
- Line management experience preferred or, at the minimum, team leader experience
- Ability to work independently and in a team environment
- Excellent people management, time management, project management, and organizational skills
- A track record of high 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 working knowledge of core trial management systems and tools.

**Who we are**

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for**

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
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**Requisition ID**:R251842