Clinical Site Manager/CRA, Northeast (NY/NJ/MA) - Astellas Pharma
New York, NY
About the Job
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 around the world. 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. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in the Northeast. Ideal candidates would be located in New York, New Jersey or the Boston area. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
The primary purpose of the Clinical Site Manager II (CSM II) is to serve 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 Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Clinical Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols.
Responsibilities may include assisting with or primary responsibility for:
+ 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
Essential Job Responsibilities:
+ 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 ensure 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.
Quantitative Dimensions:
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.
Organizational Context:
Reports to the regional Site Management Lead Early or Late-Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role.
Qualifications:
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 Oncology or other directly relevant 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. Depending on hiring region, may also be required to be fluent in local language.
+ 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 Oncology studies
Benefits:
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 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
+ Referral bonus program
+ Fleet Car
#LI-SS
Category Early Development Clinical Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. 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. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in the Northeast. Ideal candidates would be located in New York, New Jersey or the Boston area. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
The primary purpose of the Clinical Site Manager II (CSM II) is to serve 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 Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Clinical Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols.
Responsibilities may include assisting with or primary responsibility for:
+ 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
Essential Job Responsibilities:
+ 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 ensure 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.
Quantitative Dimensions:
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.
Organizational Context:
Reports to the regional Site Management Lead Early or Late-Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role.
Qualifications:
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 Oncology or other directly relevant 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. Depending on hiring region, may also be required to be fluent in local language.
+ 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 Oncology studies
Benefits:
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 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
+ Referral bonus program
+ Fleet Car
#LI-SS
Category Early Development Clinical Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Source : Astellas Pharma