Astellas Pharma
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.
Purpose
A Clinical Site Manager (CSM) 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 Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. 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 Reports to the regional Site Management Lead Early or Late Stage Site Monitoring & Management Organization. Essential Job Responsibilities
Acts as primary local company contact for assigned sites for specific 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. Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring and site management. Ensures site staff are trained and the corresponding training records are complete and accurate. Ensure site compliance with study protocol, ICH-GCP, and local/country regulations. Ensure ongoing adequacy of site for trial conduct. Involved with site level recruitment strategy and prioritization and implementation. Qualifications Required
BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience. 5 years site monitoring and/or site management experience. A minimum of 2 years of Oncology, Ophthalmology, and/or Gene Therapy or other directly relevant therapeutic area experience. Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures. Strong critical thinking and problem-solving skills. Strong IT skills in appropriate software and company systems. Preferred
Experience working cross-functionally and in matrix teams Experience in executing Lead CSM role Experience mentoring more junior site monitors or site managers Working Environment
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. Benefits
Medical, Dental and Vision Insurance Generous Paid Time Off options, including Vacation and Sick time, plus national holidays 401(k) match and annual company contribution Company paid life insurance Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans
#J-18808-Ljbffr
A Clinical Site Manager (CSM) 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 Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. 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 Reports to the regional Site Management Lead Early or Late Stage Site Monitoring & Management Organization. Essential Job Responsibilities
Acts as primary local company contact for assigned sites for specific 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. Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring and site management. Ensures site staff are trained and the corresponding training records are complete and accurate. Ensure site compliance with study protocol, ICH-GCP, and local/country regulations. Ensure ongoing adequacy of site for trial conduct. Involved with site level recruitment strategy and prioritization and implementation. Qualifications Required
BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience. 5 years site monitoring and/or site management experience. A minimum of 2 years of Oncology, Ophthalmology, and/or Gene Therapy or other directly relevant therapeutic area experience. Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures. Strong critical thinking and problem-solving skills. Strong IT skills in appropriate software and company systems. Preferred
Experience working cross-functionally and in matrix teams Experience in executing Lead CSM role Experience mentoring more junior site monitors or site managers Working Environment
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. Benefits
Medical, Dental and Vision Insurance Generous Paid Time Off options, including Vacation and Sick time, plus national holidays 401(k) match and annual company contribution Company paid life insurance Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans
#J-18808-Ljbffr