Astellas Pharma · 2 days ago
Oncology CRA/Clinical Site Monitor (field-based) - NY/NJ
New York, NY
Full-time
Hybrid
Mid, Senior Level
$122K/yr - $192K/yr
5+ years expAstellas Pharma is a pharmaceutical company focused on developing innovative therapies for patients. The Clinical Site Manager II will serve as the primary contact between the Sponsor and Investigational Sites, ensuring compliance with clinical trial protocols and managing site relationships throughout the trial process.
BiotechnologyHealth CareMedical
Responsibilities
Site Selection
Pre-trial assessment
Site level Study Participant recruitment/retention plans
Site Activation/Initiation
On-site and remote monitoring
Overall site relationship management in collaboration with other sponsor roles that interact with the site
Close-out activities
Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials
Develops meaningful site relationships through consistent collaborative communication and engagement
May participate in site feasibility and/or pre-trial site assessment visits
Attends/participates in investigator meetings as needed
May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensures study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study
Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk-based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits
Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe
Ensure site compliance with study protocol, ICH-GCP, and local/country regulations
Ensure ongoing adequacy of site (facilities, staff) for trial conduct
Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA
Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas
Ensures site non-IMP study supplies are adequate for trial conduct
Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed
Oversees the appropriate destruction of clinical supplies
Ensures site staff complete data entry and resolve queries within expected timelines
Ensures validity and completeness of data collected at trial sites
Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate
Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management
Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders
Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times
Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities
Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits
Prepares trial sites for close out, conduct final close out visit
Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff
May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate
May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines
Qualification
Required
BA/BS degree with ≥5years of experience in pharmaceutical related drug development or direct equivalent experience
Five years site monitoring and/or site management experience
A minimum of 2 years of early phase Oncology therapeutic area experience
Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines
Strong critical thinking and problem-solving skills
Strong IT skills in appropriate software and company systems
Willingness to travel up to 40% with overnight stay away from home
Proficient in speaking and writing English
Good written and oral communication
Preferred
Experience working cross-functionally and in matrix teams
Experience in executing Lead CSM role
Experience mentoring more junior site monitors or site managers
Experience working in early development studies
Benefits
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
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
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
10001+ employees
H1B Sponsorship
Astellas Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (4)
2022 (2)
2021 (3)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
National Institute on Drug Abuse (NIDA)
2020-07-22Grant
2008-10-13IPO
Leadership Team
Amanda Hart
Head, Global Commercial Analytics and Reporting
Recent News
2026-01-07
Company data provided by crunchbase