Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and management of Otsuka clinical studies, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Otsuka SOPs, within agreed-upon timeframes and budget.
• Provides oversight and management of clinical studies at Otsuka, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Otsuka SOPs.
• Contribute to the development and review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents.
• Provide input into and approval of the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites.
• Provide leadership and guidance to clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Otsuka SOPs.
• Communicates and coordinates clinical project-related activities and progress across all relevant cross-functional departments.
• Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required.
• Participate in forecasting study expenditures and resourcing needs.
• Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast.
• Provide timely communication of any variances in budget forecast to the Director/Associate Director.
• Establish communication flow with CRO and investigative sites to maximize compliance with study protocol.
• Provide oversight of ESP in its conduct of the day-to-day operations of assigned trial(s), as assigned.
• Participates in ongoing review of clinical trial data focusing on data integrity, trending and consistency.
• Supports project level inspection readiness activities, including responsibility for ensuring the completeness, timeliness and quality of the TMF.
• Serve as Clinical Management representative for review of protocols within and across portfolios, as assigned.
• Participate in program-level risk mitigation strategies and collaborate with ESPs on study-level risk mitigation and management activities.
• Represent Clinical Management in departmental and cross-functional initiatives, as assigned.
• Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts.
• May have supervisory responsibilities including:
o Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes.
o Assuring compliance with departmental, SOP, compliance, and corporate training
o Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities.
o Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance.
• Performs other duties, as assigned.
Knowledge/ Experience and Skills:
• Comprehensive knowledge of clinical operations, drug development process, roles, and responsibilities of individuals within the project team, standard operating procedures (SOPs) and GCP/ICH regulations.
• Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW).
• Strong understanding of the clinical and scientific basis for assigned clinical program, with the ability to translate that knowledge in operational management.
• Strong understanding of global regulatory requirements.
• Strong communication, organization, planning, analytical, problem solving, and people management skills.
• Demonstrated experience with working with the Microsoft suite of programs (e.g., Word, Excel, PowerPoint, Outlook, etc.)
• Good understanding of clinical trial related software (e.g., eCRFs, IRT, CTMS, etc.).
• Ability to travel up to 25%.
• Bachelor's Degree or Registered Nurse (RN). Minimum of 10 years industry experience with seven (7) years in clinical trial management experience.
• Previous supervisory experience.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
Valid Proof of COVID-19 Vaccination or Accommodation
The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.
Statement Regarding Job Recruiting Fraud Scams
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.
Add your resume to our resume database that can be searched by employers looking to hire!
Stay up to date with job alerts! Customize your alerts based on a specific area, category and receive weekly updates!