Patient safety study manager Job at Randstad (Tokyo)

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...

Location

United States; Canada , Remote; Alberta

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Good knowledge of drug safety and the drug development process
Good knowledge/understanding of medical terminology
Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice
3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required
US Board Certification/board eligibility or regional equivalent for Canada
Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
Completion of at least basic training in clinical medicine (residency, internship etc.)
Demonstrated success in technical proficiency and scientific creativity
Good presentation and verbal/written communication skills

Job Responsibility

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs
as applicable) and liaising with the client, as require
Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
Review appropriateness of medical content in narrative for medical coherence
Assessing seriousness, listedness / expectedness of reported events
Providing medical inputs to case processing team
Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative

What we offer

Flexible approach to work that meets your personal needs
Work from home
Benefits vary by country
Investment in your professional and personal development

Aprn / Pa Inpatient - Internal Medicine

Function in a specialized area of advance practice in the role of practitioner, ...

Location

United States , Albuquerque

Salary:

53.29 - 82.51 USD / Hour

UNM Hospitals

Expiration Date

Until further notice

Requirements

Program Graduate
Advanced Nurse or Physician Assistant
1 year directly related experience
CPR for Healthcare/BLS Prov or Prof Rescuers w/in 30 days
Advanced Practice RN or Physician Asst Lic & NCCPA Cert
Pediatric Nursing Certification as applicable
ACLS or PALS (as applicable) within 30 days of hire
Prescriptive Authority from the State of New Mexico
State of New Mexico and Federal DEA Certification

Job Responsibility

PATIENT CARE - Assess, diagnose and develop treatment plans
implement treatment, follow-up and evaluate patient within the scope of practice protocols as outlined by state statute
PATIENT CARE - Perform patient history and physical exams as needed for procedures or admissions
document findings noting pertinent normal and abnormal findings
PATIENT CARE - Complete admitting orders, daily rounds and orders, consultations with nurses, specialist and ancillary staff, discharge summary, transfers, medication management and other orders as required for the management of patient care
PATIENT CARE - Perform invasive and non-invasive diagnostic and therapeutic procedures
PATIENT CARE - Order and interpret appropriate diagnostic procedures and tests. Explain the necessity of preparation, nature, and anticipated effects of procedures to patient and patient’s family
PATIENT CARE - Evaluate and revise intervention care/treatment plan with patient and family as necessary to achieve improved health
PATIENT CARE - Provide education for patients and/or families about preventative care, medical issues and use of the prescribed medical treatment
DOCUMENTATION - Provide accurate documentation of patient care, document orders, directives, procedures and patient responses in the medical record and communicate them to other members of the health care team

What we offer

Sign-On Bonus Available
Relocation Assistance Available

Fulltime

Aprn/pa Inpatient - Metropolitan Detention Center

Function in a specialized area of advance practice in the role of practitioner, ...

Location

United States , Albuquerque

Salary:

53.29 - 82.51 USD / Hour

UNM Hospitals

Expiration Date

Until further notice

Requirements

Program Graduate
Advanced Nurse or Physician Assistant
1 year directly related experience
CPR for Healthcare/BLS Prov or Prof Rescuers w/in 30 days
Advanced Practice RN or Physician Asst Lic & NCCPA Cert
Pediatric Nursing Certification as applicable
ACLS or PALS (as applicable) within 30 days of hire
Prescriptive Authority from the State of New Mexico
State of New Mexico and Federal DEA Certification

Job Responsibility

PATIENT CARE - Assess, diagnose and develop treatment plans
implement treatment, follow-up and evaluate patient within the scope of practice protocols as outlined by state statute
PATIENT CARE - Perform patient history and physical exams as needed for procedures or admissions
document findings noting pertinent normal and abnormal findings
PATIENT CARE - Complete admitting orders, daily rounds and orders, consultations with nurses, specialist and ancillary staff, discharge summary, transfers, medication management and other orders as required for the management of patient care
PATIENT CARE - Perform invasive and non-invasive diagnostic and therapeutic procedures
PATIENT CARE - Order and interpret appropriate diagnostic procedures and tests. Explain the necessity of preparation, nature, and anticipated effects of procedures to patient and patient’s family
PATIENT CARE - Evaluate and revise intervention care/treatment plan with patient and family as necessary to achieve improved health
PATIENT CARE - Provide education for patients and/or families about preventative care, medical issues and use of the prescribed medical treatment
DOCUMENTATION - Provide accurate documentation of patient care, document orders, directives, procedures and patient responses in the medical record and communicate them to other members of the health care team

What we offer

Sign-On Bonus Available
Relocation Assistance Available
Additional $6.00/hr. Safety Incentive Pay

Fulltime

Global Trial Manager - Early Development

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States , CARY, BLUE BELL, RAHWAY, NJ

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS/BSc or RN
At least 4+ years experience overseeing clinical trials including the oversight of Functional Service Providers, and outside vendors (CROs, central labs, imaging vendors, etc.)
Experience overseeing early phase studies (phase I) for biotech, pharmaceutical or CRO
Strong clinical project management skills and experience in driving milestones
Excellent communication and interpersonal skills to effectively work with cross-functional teams
Proficient in trial management systems and MS Project (or equivalent PM software)
Knowledge of ICH/GCP and regulatory guidelines/directives

Job Responsibility

Leads the study level planning and execution of overall operational deliverables, including study level forecast of investigational products and study logistics plan
Develops the strategic scenarios of designs for early phase clinical development plan
Ensures standard processes, tools, and procedures are used consistently
Routine engagement with Clinical Investigators
Provide oversight, support the design, and manage operational activities related to the planning, implementation, and reporting of outsourced Clinical Pharmacology studies
Leads, manages, and monitors overall study related activities including: Issues related to patient eligibility, enrollment and protocol deviations
Ongoing safety data review and completion of study data collection, data lock, and analysis
Resolution of cross-functional study-specific issues
Communication of study status to key stakeholder and updating relevant systems
Ensures study personnel are appropriately trained and understand study timelines and deliverables

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Local Study Associate Director

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor degree in related discipline, preferably in life science, or equivalent qualification
Five years of US focused clinical trial management experience, including budget oversight
Good knowledge of international guidelines ICH- GCP as well as relevant local regulations
Excellent project management skill
Excellent team building and interpersonal skills
Excellent organisational skills
Excellent verbal and written communication skills
Excellent ability to prioritize and handle multiple tasks
Excellent attention to details
Excellent knowledge of spoken and written English

Job Responsibility

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality
Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations
Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks
Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study
Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations
Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head
Ensures timely preparation of local Master CSA (including site budget) and amendments as needed
Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant SOPs and local regulations
Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with SOPs

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Manager, Patient Safety and Pharmacovigilance Operations

Reporting to the Senior Director, Patient Safety and Pharmacovigilance (PSPV) Op...

Location

United States , Waltham

Salary:

110000.00 - 140000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Minimum of 6+ years of experience in Drug Safety/Pharmacovigilance Operations within the pharmaceutical or biotechnology industry
Working knowledge of global PV regulations, including FDA and ICH guidelines
Demonstrated working knowledge of safety databases (e.g., Argus), especially reports generation, PV dashboard, etc
Demonstrated ability to work collaboratively in a fast-paced, cross-functional, and matrixed environment with strong organizational, time management, and project prioritization skills. Excellent verbal and written communication and interpersonal skills
Prior PV Operations and safety vendor management experience required
Adaptable to changing priorities
Proficient computer skills, including Microsoft Word and Excel
Must be able and willing to travel on occasion
Bachelor’s degree in Life Sciences (or equivalent experience) or a related field required. (BS, RN, preferred)

Job Responsibility

Act as a subject matter expert on emerging global guidelines and regulations, assessing impact on existing procedures, and recommending updates
Support PSPV Operations in the development and maintenance of safety vendor documentation (e.g., SMP, SAE/AESI, Pregnancy Reporting forms, etc.)
Responsible for the oversight of the safety vendor ICSR case processing and reporting activities (e.g., ensuring high quality and compliant case processing and submission activities including narrative writing, coding (MedDRA), query resolution, reports generation, study closure, etc.), SAE Reconciliation support, and safety vendor metrics (e.g., KPIs and KQIs, etc.) as defined in the SMP
Act as primary day-to-day liaison with the safety vendor project manager and team leads to ensure efficient case workflow to meet PSPV and alliance partner obligations
Support in-line and/or retrospective case quality review (e.g., to assess coding accuracy, narrative completeness, data integrity, regulatory compliance, etc.)
Develop and maintain a robust and easily navigable PSPV SharePoint repository
Document, track, and escalate issues or quality trends as per process and the PV Quality Agreement. Identify process or quality gaps and contribute to effective, stage appropriate, and compliant solutions
Collaborate with the safety vendor to provide timely delivery of internal and external safety database data extract requests and support safety database activities (e.g., database updates, processes, new study configurations, access issue escalations, case processing conventions, system implementation/transitions, etc.)
Contribute to controlled document development and maintenance (e.g., SOPs, WIs, SAE/pregnancy forms, SMPs, etc.) and support inspection readiness activities
Support PSPV Aggregate reporting activities (e.g., signal detection, DSUR, risk management, literature review, etc.), as required

What we offer

comprehensive health coverage
flexible time off
paid holidays
a year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

New

Staff Nurse- Cardiothoracic OR

The Clinical Nurse is a Registered Professional Nurse who provides safe, compete...

Location

United States , New York

Salary:

62.36 USD / Hour

Mount Sinai Health System

Expiration Date

Until further notice

Requirements

Graduation from an accredited Nursing program
Bachelor’s Degree in Nursing (BSN)
Associate’s Degree in Nursing (ADN) RN who is matriculated in a BSN Program with a graduation date within the year
Any Associate’s Degree in Nursing (ADN) RN with Nursing experience must be approved by the CNO
Relevant clinical competence in area of nursing practice assigned
new graduates must possess current knowledge of the nursing process and its application
Licensed as a registered nurse with current registration in New York State
Basic Life Saver (BCLS) Issuing Agency: AHA
Must have Operating Room and Cardiac OR experience

Job Responsibility

Delivers patient care by incorporating the tenets of the professional practice model of Relationship Centered Care and through the application of the nursing process based upon theory, research, evidence-based practice, and approved organizational nursing standards
Assesses and evaluates patient care needs and applies critical thinking skills in patient care management
Integrates relevant assessment and intervention skills in the delivery of nursing care
Collaborates with the interdisciplinary healthcare team in the development, implementation, and evaluation of the plan of care
Prioritizes all aspects of patient care including teaching, rounding, coaching, and planning after hospital care and delegating to others as appropriate
Educates patients and caregivers while anticipating needs and readiness to learn, about their plan of care, transition of care, promotion of health, and prevention of disease
Communicates effectively and professionally with patients, family and all members of the Interdisciplinary Patient Care Team
Manages assignments within the Care Delivery Model of Modified Primary Nursing and demonstrates allocation of material resources effectively
Role models the tenets of Mount Sinai Relationship Centered Care (MSHRCC)
Considers the patients values, preferences, expressed needs and knowledge in all aspects of care

Fulltime

Patient safety study manager

Randstad

Location:
Japan , Tokyo ▼
Osaka

Category:
Pharmacy

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
May 01, 2025

Expiration:
February 13, 2026

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Job Description:

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