Senior Clinical Research Associate II

For seasoned clinical monitoring professionals, the Senior Clinical Research Associate II (SCRA II) represents a premier leadership track within Pfizer’s GSSO organization. In this high-impact, expert-level role, you are not only accountable for safeguarding patient safety and clinical quality at the site level, but you also serve as a pillar of leadership for our broader monitoring community.

You will manage complex investigator relationships, drive site performance, lead global/regional process improvement initiatives, and step into elevated Site Care Partner (SCP) responsibilities for smaller projects. By mentoring both CRAs and Senior CRAs I, you will cultivate clinical excellence, represent Pfizer's scientific leadership to health care professionals, and drive the operational strategies that bring life-saving breakthroughs to patients.

In this distinguished, senior-leadership monitoring role, your responsibilities include:

• Expert Clinical Monitoring: Ensure superior clinical conduct across assigned investigator sites in accordance with Study Monitoring Plans, GCP, local laws, and Pfizer standards.

• Community Leadership & Mentorship: Lead, motivate, and align the monitoring community. Act as a dedicated mentor and trainer for both CRAs and Senior CRAs I.

• Operational Autonomy & SCP Duties: Perform the duties of a Site Care Partner (SCP) for small projects, or under the guidance of an SCP on larger projects (encompassing feasibility, site selection, PTA, site activation checklist coordination, ICD finalization, and SIV management).

• Strategic Process Improvement: Participate in or lead global, regional, or local working groups and strategic process improvement initiatives. Serve as a core SME for CRA processes.

• Regulatory & Audit Excellence: Lead site preparation and serve as a central point of contact for regulatory inspections, audits, and Audit Observation CAPA developments. Drive Quality Event remediation processes.

• Site Management & Support: Conduct onsite, remote, and co-monitoring activities. Oversee investigational products, resolve data queries, assess e-diary data, monitor site-level safety (AEs/SAEs) with the Drug Safety Unit, and establish preventive actions to prevent open issues from persisting.

• High-Level Collaboration: Interface directly with health care professionals to enhance Pfizer's credibility, and partner with Country SOMs, Clinicians, and Study Team members to support clinical development goals.

• Education: Bachelor’s degree in Life Sciences, or a professional degree in nursing, pharmacy, medical background, or equivalent.

• Core Knowledge: Extensive, superior knowledge of clinical trial methodologies, ICH/GCP, FDA, and local regulations.

• Experience: Minimum of 5 years of relevant experience in clinical research site monitoring (with a preference for 3 years of experience in Oncology).

• Global Exposure: Prior global clinical trial experience is required.

• Language Skills: Fluency in English and the native language(s) of the country you will work in.

• Preferred Experience: Therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.

• Superior knowledge of clinical R&D processes and advanced feasibility/protocol design processes.

• Proven leadership capability to motivate, align, and mentor the monitoring team.

• Exceptional matrix collaboration, influence, and relationship-building skills.

• Superior capability to critically evaluate, present, and mitigate complex operational risks.

• Travel Commitment: This role requires significant travel (60% to 80%) within your assigned cluster. Occasional international and weekend travel may be required.

• Requirements: A valid driver’s license and passport are required.

Please apply by sending your CV in English.

Work Location Assignment: Remote

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.