Clinical Research Associate – Senior

Jobtailor; Deutschland; Vor Ort; EUR 70.000 - 95.000; Vollzeit

Benefits dieser Stelle

Paid parental leave

Health & Wellness programs

Career Growth Experiences program

Recognition & rewards program

Life Insurance Benefits

Pfizer Learning Academy access

Zusammenfassung

Pfizer Australia and New Zealand seeks a Senior Clinical Research Associate I to partner with investigator sites, lead site management and monitoring from start-up to close-out, and ensure patient safety and data quality.

You will work across oncology studies, manage risk-based monitoring, and collaborate with cross-functional teams to accelerate trial delivery while maintaining GCP standards. Extensive travel (60-80%) and global coordination are expected.

Qualifikationen

• Bachelor's degree in life sciences or nursing/pharmacy/medical background
• Extensive knowledge of ICH-GCP, FDA and country regulations
• Minimum 3 years' site monitoring experience (Oncology preferred)

Aufgaben

• Lead site management and monitoring across assigned sites per protocol and GCP
• Be primary contact for investigator sites to support delivery and trial outcomes
• Manage site operations from start-up to close-out with milestones and quality objectives
• Conduct onsite, remote, and risk-based monitoring visits
• Collaborate with Site Care Partners and cross-functional teams to mitigate risks and resolve issues
• Support patient recruitment and enrollment with investigators
• Provide protocol guidance and training to site personnel
• Maintain study documentation and regulatory compliance

Kenntnisse

Clinical trial monitoring

Site management

Risk-based monitoring

Communication skills

English proficiency

Ausbildung

Bachelor's degree in life sciences

Jobbeschreibung

Use Your Power for Purpose

Reporting to the ANZ GSSO Leadership, you will play a critical role in delivering high-quality clinical trials by partnering with investigator sites to ensure patient safety, regulatory compliance, and operational excellence. As a Senior Clinical Research Associate I you will serve as a trusted partner to investigators and study teams, leading site management and monitoring activities from study activation through closeout.

By building strong site relationships, proactively managing risks, resolving protocol-related issues, and supporting site performance, you will help accelerate the delivery of clinical research while maintaining the highest standards of quality and Good Clinical Practice. Working closely with Site Care Partners and cross-functional study teams, your expertise will contribute to successful enrollment, data integrity, database release, and the generation of evidence that advances innovative medicines for patients worldwide.

What You Will Achieve

• Lead site management and monitoring activities across assigned clinical trial sites, ensuring studies are conducted in accordance with protocol, Good Clinical Practice (GCP), regulatory requirements, and Pfizer standards.
• Serve as the primary point of contact for investigator sites, building strong partnerships to support high-quality study delivery and successful trial outcomes.
• Manage site operations from study start-up through closeout, ensuring key milestones, timelines, and quality objectives are achieved.
• Conduct onsite, remote, and risk-based monitoring activities, including site initiation, routine monitoring visits, and closeout visits.
• Partner with Site Care Partners and cross-functional study teams to identify and mitigate risks, resolve site issues, and drive operational excellence.
• Support patient recruitment and enrollment efforts by collaborating with investigators and study teams to address site-level challenges and implement recruitment strategies.
• Provide protocol guidance, training, and coaching to investigator site personnel to ensure compliance, quality execution, and patient safety.
• Develop and maintain strong scientific and operational knowledge of study protocols, investigational products, and therapeutic areas to effectively support investigators and site teams.
• Drive the identification, escalation, and resolution of site quality, compliance, and data integrity issues, including implementation of corrective and preventive actions (CAPAs).
• Monitor and support patient safety activities, including adverse event and serious adverse event reporting and follow-up.
• Ensure timely completion and maintenance of essential study documentation, trial records, and regulatory compliance requirements throughout the study lifecycle.
• Contribute to continuous improvement initiatives by mentoring junior CRAs, sharing best practices, and participating in local and regional process improvement projects.

Here Is What You Need (Minimum Requirements)

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
• Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
• Global clinical trial experience
• Proficiency in English, both written and verbal
• Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
• Valid driver’s license and passport required

Bonus Points If You Have (Preferred Requirements)

• Master’s degree with experience in early drug development.
• Ability to manage multiple projects simultaneously
• Strong analytical and problem‑solving skills
• Excellent communication and presentation skills
• Experience using common AI tools, including generative technologies such as Microsoft Copilot or Gemini, to support problem solving and enhance

At Pfizer we care about our colleagues’ wellbeing and offer a range of great benefits for them, including:

• Paid parental leave
• Access to Health & Wellness apps
• Career Growth Experiences program
• Recognition & rewards program
• Paid volunteer days
• Life Insurance Benefits
• Pfizer Learning Academy access to top content providers
• Access to flu vaccines & skin checks
• Options to purchase additional leave
• Salary packaging & novated lease options

*Benefits listed may vary depending on your position and location and may be subject to change.

Pfizer Australia and New Zealand’s diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.

If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.