Country Clinical Quality Manager

Exciting opportunity to work directly with a Global Biopharma

Permanent Full-Time role based in Macquarie Park, Sydney Australia

Great opportunity to work on innovative trials

The Opportunity

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare 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.

What You Will Do

• Responsibilities include, however not limited to

It is critical that, for all our company's sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The Country Clinical Quality Manager (CCQM) position has a significant impact in achieving those objectives.

Under the guidance of the Regional Director, Clinical Quality Management (RCQM), the CCQM oversees all CQM activities in the respective country / cluster.

The role requires the ability to properly implement local / global processes / procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support audits, inspections as well as Quality Control and local training activities.

What You Must Have

Bachelor's Degree or equivalent in relevant health care area

Extensive prior relevant experience in clinical research including direct field monitoring experience or management / oversight of such individuals, with a demonstrated record of accomplishments Experience in Country Operations preferred

Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research related regulations

Ideally, experience in Clinical Quality Management including Quality Control Activities, Process Management & Improvement

Ideally, experience in managing audits and inspections

Ideally, experience in coordinating and delivering training sessions

Superior oral and written communication and leadership skills in an international environment.

Excellent project management, organizational and prioritization skills

Excellent teamwork skills, including conflict resolution expertise and discretion

Ability to analyze, interpret, and solve complex problems

Ability to think strategically, objectively and with creativity and innovation

Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results

What You Can Expect

Be exposed to innovative clinical trials

Work with a passionate and supportive ANZ Team

Work within a company that truly takes pride on their purpose of "Patients first, Profits Later"

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.

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.

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Regular

No relocation