Why This Role Matters
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.
The Impact You Will Make
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.
What You Bring
• 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.
Key Skills
• 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.
Work Schedule, Travel & Environment
• 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
Purpose Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
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