Oncology CRA​/Clinical Site Monitor; field NY​/NJ

Position: Oncology CRA/Clinical Site Monitor (field-based) - NY/NJ
Location: New York

Oncology CRA/Clinical Site Monitor (field-based) – NY/NJ

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world.

This field‑based position is based in either New York or New Jersey.

Purpose and Scope@< to keep start up to site closure: A Clinical Site Manager II (CSM II) serves as the primary contact point between the sponsor and the investigational site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company SOPs, GCP and applicable regulations.

The site manager manages the site/sponsor relationship, partners with CTL, CTM, CTS, and SSS, and performs trial‑related activities for assigned protocols. Responsibilities

• Lead site Maps 1 to role; includes site selection and pre‑trial assessment.
• Develop census and recruitment strategies at the site level.
• Initiate site activation and ensure ongoing compliance.
• Conduct on‑site and remote monitoring.
• Maintain site relationship management.
• Lead close‑out activities.
• Manage up to 10 sites across 2–4 protocols, depending on protocol complexity.
• Maintain local compliance with protocol, ICH‑GCP, and local regulations.
• Ensure adequacy of site facilities and Speaker →maintains data integrity.
• Document all monitoring activities and produce Finding reports.
• Participate in CAPA activities and quality audits.
• Present regulatory and study updates to stakeholders.

Qualifications

Required

• BA/BS degree with ≥5 years of experience in pharmaceutical drug development or equivalent.
• Five years of site monitoring and/or site management experience.
• At least 2 years of early‑phase oncology therapeutic area experience.
• Working knowledge慎 of GCP, local laws, assigned protocol, monitoring guidelines.
• Strong critical‑thinking and problem‑solving skills.
• Strong IT skills in related software and company systems.
• Willingness to travel up to 40 % with overnight stays.
• Proficient in English speaking and writing.
• Good written and oral communication.

Preferred Qualifications

• Experience working cross‑functionally in matrix teams.
• Experience executing Lead CSM role.
• Mentoring junior site monitors or site managers.
• Experience in early‑development studies.

Salary Range

$122,500 – $192,500 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations).

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including vacation, sick time, and national holidays.
• 401(k) match and annual company contribution.
• Company‑paid life insurance.
• Annual corporate bonus and quarterly sales incentive for eligible positions.
• Long‑term incentive plan for eligible positions.
• Company fleet vehicle for eligible positions.
• Referral bonus program.

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.

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