Clinical Site Manager II

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 Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The 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
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.

Work content and job description
(Upon hire)
•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/sub-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.

Common to all Job Types
Annual Salary :

7 million yen
~
12 million yen

Education and Degree Requirements
Ph.D. / Doctor
/

Master
/

Bachelor

Description
＜必須 / Required＞
•BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience CSM.
•Five years site monitoring and/or site management experience.
•Demonstrated ability to independently manage assigned sites, prioritize competing activities, resolve routine and complex site issues, and escalate risks appropriately with limited supervision.
•A minimum of 2 years of 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. Depending on hiring region, may also be required to be fluent in local language.
•Strong stakeholder management skills with investigators, site staff, cross-functional study team members, vendors/CROs, and regional/global functions.
•Good written and oral communication.
＜歓迎 / 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

Common to all Job Types
Tenured

-

Non-tenure track

Supplementary explanation of compensation
【Salary】
①Base salary: will be decided by the candidate's experience, skill and capability.
②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000～100,000yen, based on the Grade)
③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.
【Salary Raise】
Available
【Bonus】
Available
【Allowance】
Discretionary work allowance, Housing allowance, Commutation allowance, etc.
【Working Hours】
8:45～17:45（Mon～Thu）、8:45～16:00（Fri）
Discretionary Work System
【Holidays】
Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays
【Vacation Leave】
Annual paid leave, childcare leave system, nursing care leave system, etc.

Selection
CV screening → First interview → 2nd Interview → Final interview
*Please be advised that there might be a change in the process.

Notification of result
You will be notified of the results of your application through the system.
For more information about Astellas, please visit our career web site.