Senior Clinical Site Manager Job at iconplc (Melbourne)

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

Senior Clinical Research Associate

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

Location

Taiwan , Taipei

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree in a relevant field such as life sciences, nursing, or medicine
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license

Job Responsibility

Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations

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 Coordinator

The Computational Health Informatics Program (CHIP) is seeking an experienced, h...

Location

United States , Boston

Salary:

58676.80 - 93901.60 USD / Year

Boston Children's Hospital

Expiration Date

Until further notice

Requirements

Bachelor’s degree
Master’s preferred
Bachelor’s degree and 4 years of relevant work experience OR Master’s degree and 2 years of relevant work experience
Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex
Well-developed communication skills to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions
Ability to effectively engage with and influence others
build working relationships and can work independently and as a team member, leads others when needed
Act as a resource and must be knowledgeable and compliant in all hospital, State, and Federal regulatory requirements, including hospital policy and procedures

Job Responsibility

In conjunction with the Principal Investigator and/or designees designs, develops, and implement clinical research projects such as enrollment strategies, study materials, and study documents
Responsible for daily operations of the study
Develops and implements processes and procedures to meet study goals and protocol requirements
Participate in training and prepare study related training materials
Plans and prioritizes the work of administrative and support personnel on all clinical study activities
Consents and enrolls patients for research studies by providing detailed information on the Clinical Study to patients and families
Communicates all policies and procedures and responds to all inquiries
Evaluate the suitability of prospective study candidates and make selections based on clinical knowledge of each study
Provide input for updates of SOPs and drafting of new quality documentation
Assist with developing and implementing best practice guidelines for conducting various clinical research protocols

What we offer

flexible schedules
affordable health, vision and dental insurance
child care and student loan subsidies
generous levels of time off
403(b) Retirement Savings plan
Pension
Tuition and certain License and Certification Reimbursement
cell phone plan discounts
discounted rates on T-passes

Fulltime

Senior Clinical Research Associate

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

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Excellent attention to detail
Good written and verbal communication skills
Good collaboration and interpersonal skills
Good negotiation skills
Proficient in written and spoken English language required
Fluency in local language(s) required
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
Good knowledge of relevant local regulations
Good medical knowledge and ability to learn relevant Client Therapeutic Areas
Basic understanding of the drug development process

Job Responsibility

Contributes to the selection of potential investigators
In some countries, as required, accountable for study start-up and regulatory maintenance
Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles
Confirms that site staff have completed and documented the required training appropriately
Actively participates in Local Study Team (LST) meetings
Contributes to National Investigators meetings, as applicable
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents
Shares information on patient recruitment and study site progress
Drives performance at the sites
Proactively identifies and ensures timely resolution to study-related issues

What we offer

Patient-focused in everything we do
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

Fulltime

Senior Clinical Application Specialist

Looking for an exciting challenge? A change in pace using your Rad Tech skill to...

Location

Egypt , Cairo

Salary:

Not provided

PaxeraHealth

Expiration Date

Until further notice

Requirements

Excellent English Language
Experience as a radiology technologist or in similar clinical role
A deep understanding of medical imaging and the challenges faced by professionals in this industry
A Bachelor’s degree in Radiology, Biomedical Engineering or similar field
Strong presentation skills with sales ability
Ability to absorb and convey highly technical information
A hands-on and customer-centric approach
Must be able to travel to demonstrate to clients and to trade shows on occasion
Good time management skills and ability to prioritize tasks
Ability to work as part of a team

Job Responsibility

Serve as a software expert to clients and internal team members
Conduct webinars and workshops to demonstrate and provide technical expertise, support and training to clients as it relates to PaxeraHealth applications remotely and on-site
Create presentations, videos and other training materials as required for webinars, workshops and training sessions
Interfaces between clients/potential clients and company development team, skillfully forwarding pertinent suggestions and ideas to development for inclusion in future enhancements of software
Participate in the product development process
Develop and manage software documentation and technical support content including user manuals video-based tutorials and training tools
Attend conferences and exhibitions, meet with clients and demonstrate PaxeraHealth medical imaging solutions
Help with the product setup process as well as provide product presentations to customers and visitors during trade shows
Work together with technical teams and user groups to solve clients’ problems with available technology including hardware, software, databases and peripherals

Fulltime

Senior Site Management Associate

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

Location

Romania , Bucharest

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences, clinical research, or a related field
Extensive experience in site management, clinical operations, or monitoring within the clinical research industry
Strong understanding of clinical trial processes, Good Clinical Practice (GCP), and regulatory requirements
Excellent problem-solving and organizational skills, with the ability to manage multiple sites and timelines
Effective communication and interpersonal skills, with a focus on collaboration and maintaining strong site relationships
Romanian language is required
Italian language is strong preference

Job Responsibility

Overseeing day-to-day site management activities, ensuring that clinical trial sites comply with study protocols, regulatory requirements, and timelines
Collaborating with site staff and cross-functional teams to resolve issues, monitor progress, and ensure timely data collection and reporting
Assisting with site initiation, monitoring visits, and close-out activities to ensure the proper execution of clinical trials
Providing guidance and mentorship to junior site management staff, fostering collaboration and process improvement
Preparing and maintaining site management documentation, including site reports, communications, and updates on site performance

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 Local Trial Manager - Oncology

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS degree
Degree in a health or science related field
3 - 5+ years of trial end to end management experience
Start-up & Database Locks/Cleaning experience preferred
Oncology Solid Tumor experience required
Specific therapeutic area experience may be required depending on the position
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
Strong IT skills in appropriate software and company systems
Willingness to travel with occasional overnight stay away from home according to business needs
Proficient in speaking and writing the country language and English

Job Responsibility

Ensuring top-quality end-to-end trial delivery at a country level
Managing the consistency of Local Trial Management duties and processes
Serving as the country-level single point of contact on the study for internal partners
Managing and overseeing Central IRB and other local vendors
Execution of local milestones from feasibility through study close out
Resourcing of country-level roles
Inspection Readiness and AQR at the country level
Close collaboration with assigned Local Trial Manager(s), Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers
Efficient communication with Clinical Trial Managers, Clinical Operations and Global Trial Leader
Country level ad hoc meetings during any phase of the study

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
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Enhanced Staff Nurse & Enhanced Senior Staff Nurse

The role is responsible for the provision of quality service in line with standa...

Location

Ireland , Lucan, Co. Dublin

Salary:

Not provided

Blackrock Health Hermitage Clinic

Expiration Date

Until further notice

Requirements

Be registered in the general division of the Register of Nurses maintained by NMBI
Meet the qualifying conditions of Documented completion of clinical competencies in relation to patient care / speciality area ( Unit Competency Folder)
Evidence of ongoing personal professional development, ( Unit Competency Folder)
Completion of Mandatory Training
Evidence of participation in audit and evaluation , including collection of Quality care data or metrics
Competency in cannulation in all Hermitage Clinic nursing units, Administration of 1st Dose Antibiotics, ECG , Bladder Scanning
Flexibility to transfer or undertake rotation within the unit or between the patient care units
Submission of your annual registration with the Nursing and Midwifery Board of Ireland to the Hermitage Clinic
Ongoing skills training – relevant to care required for patient load
Have at least 17 years recent relevant post-registration nursing experience (full-time or equivalent hours part-time) in an acute hospital setting (for Enhanced Senior Staff Nurse)

Job Responsibility

Practice Nursing according to the Code of Professional Conduct as laid down by Nursing and Midwifery Board of Ireland (NMBI) (Cnáimhseachais na hÉireann) Professional Clinical Guidelines and Code of Professional Conduct and Ethics
Take measures to develop and maintain clinical competence necessary for professional and contemporary nursing practice
Contribute to the development of an expanded scope of nursing practice
Maintain a high standard of professional behaviour and be accountable for own practice
Be aware of ethical policies and procedures which pertain to area of practice
Engage with redeployment when deemed necessary by senior nursing management for service continuity, service provision and patient safety
Adhere to NMBI Guidance on Medication Administration
Ensure that controlled drug records are kept in accordance with standard recognised legal and professional practice
Keep accurate, comprehensive, up-dated records and written reports as required and guided by NMBI recommendations
Document all necessary assessments, interventions and care provided on the Meditech Patient information system

Fulltime

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Senior Clinical Site Manager

Job Description

Job Responsibility

Requirements

What we offer

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