Sr. Manager Clinical Management
Company: Otsuka Pharmaceutical
Location: Princeton
Posted on: June 26, 2022
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Job Description:
Job SummaryUnder 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.Job Description---
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 trainingo 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.Qualifications/ Required 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%.Educational
QualificationsRequired:--- Bachelor's Degree or Registered Nurse
(RN). Minimum of 10 years industry experience with seven (7) years
in clinical trial management experience.Preferred:--- Previous
supervisory experience.#LI-Remote
Keywords: Otsuka Pharmaceutical, Trenton , Sr. Manager Clinical Management, Healthcare , Princeton, New Jersey
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