Senior Clinical Site Manager Job at iconplc (Melbourne or Sydney)

Senior Clinical Trial Manager

The Senior Clinical Trial Manager (Sr. CTM) will manage the planning, execution,...

Location

United States , Waltham

Salary:

136000.00 - 170000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

8+ years of clinical trial experience, including direct management of CROs and vendors
Proven ability to lead cross-functional study teams and drive clinical programs forward independently
Deep understanding of GCP, ICH guidelines, and regulatory frameworks relevant to global clinical trial management
Strong problem-solving, organizational, and analytical skills with the ability to anticipate challenges and implement solutions
Excellent written and verbal communication skills, including stakeholder presentations and vendor negotiations
Ability to manage multiple priorities in a fast-paced environment and lead initiatives with minimal oversight
Proficient in Microsoft Office Suite, and working knowledge of project management tools (e.g., MS Project, Smartsheet)
Must be able to travel as needed
Bachelor’s degree in life sciences or a related field

Job Responsibility

Serve as the primary operational lead for assigned clinical trials
accountable for end-to-end trial execution, including oversight of CROs and vendors, from study start-up through close-out
Lead cross-functional trial teams to ensure alignment on timelines, deliverables, risk mitigation, and study objectives
Independently manage key trial activities, such as protocol development, site selection, study conduct, monitoring, data review, and database lock
Oversee and review key clinical trial documents (e.g., informed consent forms, investigator brochures, monitoring plans), ensuring quality and regulatory compliance
Monitor CRO performance to ensure adherence to study plans, timelines, budgets, and quality expectations
escalate and resolve issues proactively
Lead development and review of study plans and vendor SOPs
ensure appropriate documentation and risk mitigation strategies are in place
Ensure timely data query resolution, review of protocol deviations, and follow-through on site-related corrective actions

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Senior Clinical Research Manager - Network Operations

The Senior Clinical Research Manager (CRM) provides strategic and operational ov...

Location

United States , Brookline; Brighton; Milford; Weymouth; Methuen; Foxborough; Londonderry

Salary:

105400.00 - 130500.00 USD / Year

Dana-Farber Cancer Institute

Expiration Date

Until further notice

Requirements

Bachelor’s Degree required, with a minimum of 7+ years of related experience or Master Degree with 5+ years experience.
Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process.
Experience in protocol development, data compilation and analysis.
Skilled at developing tracking systems to ensure timely data management by the clinical research staff.
Expert knowledge of Federal and State regulations as they relate to research.
Strong interpersonal, organizational and communication skills are required.
Must have computer skills including the use of Microsoft Office and working knowledge of Livelink
EPIC and OnCore applications.
Has expert knowledge of and is fully proficient in ability to execute clinical trials start-up, active and close out phases.
Is fully proficient in their knowledge of clinical research local policy and federal regulation.

Job Responsibility

CLINICAL TRIAL OPERATIONS: Responsible for the oversight of their disease group's clinical trial portfolio and all related regulatory, compliance and performance metrics requirements.
Oversee the processing of protocols through DFCI Institutional Review Board (and other institutions' IRBs) when appropriate.
Collaborate with the DFCI Clinical Trials Office (CTO), the Office for Human Research Studies (OHRS) and the Quality Assurance for Clinical Trials (QACT) to fulfill local and federal requirements governing human clinical trials.
Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader in overseeing their resolution.
Assist the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and Contracts offices. Work with grant managers and other financial managers in the reporting and accounting of these funds.
Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials.
Work collaboratively with clinical research administration and grant managers to help monitor and reconcile all study and related grant finances as needed.
Assists the principal investigator in preparing manuscripts for publication.
Collaborate with the DFCI CTO and DF/HCC QACT to develop study forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center Trials
Oversee the subject enrollment, protocol treatment and follow-up care processes for protocol patients.

Fulltime

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

Site Manager - Healthcare Sector

The Site Manager will oversee all aspects of site preparation and readiness, inc...

Location

United Arab Emirates , Abu Dhabi

Salary:

25000.00 - 30000.00 AED / Month

Toshiba EMEA

Expiration Date

January 31, 2026

Requirements

Bachelor’s degree in Civil Engineering or a related field
A minimum of 10+ years of relevant experience in Site Management, preferably in radiotherapy, medical field, and or civil engineering
Understanding CAD drawings in essential
MEP works
Execute the project as per plan, Maintain HSEQ requirements and assist in project cash flow
The ability to explain basic design ideas and plans clearly to the Clients, Project consultants, Engineers Office, Vendors, and Subordinates
Having overall responsibility on project results including risks, opportunities and claims
Strong presentation and communication skills with the ability to present basic, technical information to a wide audience
High competence in technical writing, systems development and utilization

Job Responsibility

Ensure the customer’s physical site (hospital or clinic) meets all the infrastructure requirements: civil works, electrical supply, HVAC, radiation shielding, safety, ventilation, clean room, etc.
Coordinate site inspections & feasibility surveys
perform on‐site inspections to validate that construction / facilities are prepared according to Toshiba’s Site Preparation Guide
Work with hospital staff, architects, engineers, contractors, rigging and construction companies, local suppliers to ensure that all pieces (building, utilities, room design) match specifications
Liaise with local regulatory authorities (for safety, radiation protection, health codes) as needed
Develop and maintain project schedules along with the Project Manager for the site readiness phase: Civil Works, Installation, logistics, commissioning
Coordinate timelines with internal departments: sales, logistics, installation, service, quality, etc., to align delivery & handover
Be the main point of contact for the customer for all site-related matters: clarifying requirements, communicating delays/issues, managing expectations
Ensure a smooth handover from construction to installation teams
ensure the high level of customer satisfaction through the installation & commissioning phases

Fulltime

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

Freelance Senior Clinical Research Associate

TFS HealthScience is a leading global, mid-size Contract Research Organization (...

Location

Salary:

Not provided

TFS HealthScience

Expiration Date

Until further notice

Requirements

Bachelor’s degree, preferably in life sciences or nursing, or equivalent
Minimum of 2 years of experience working as a CRA (in oncology)
Ability to work in a fast-paced environment with changing priorities
Understanding of basic medical terminology and science related to assigned drugs and therapeutic areas
Solid understanding of Good Clinical Practice (GCP) regulations and ICH guidelines
Ability to work independently and within a team/matrix organization
Excellent written and verbal communication skills
Strong organizational skills
Ability and willingness to travel

Job Responsibility

Monitor clinical trials on-site and remotely in accordance with TFS/client SOPs, FDA regulations, and GCP/ICH guidelines
Review CRFs (paper or electronic) and subject source documentation for validity and accuracy
generate queries to resolve data issues
Identify site problems or deficiencies and report them to management through trip reports, memos, and communication with the Project Manager or Lead CRA
Initiate corrective actions as directed by the supervisor
Contribute to Ethics Committee/IRB application submissions and prepare required documentation in collaboration with the CTA and as directed by the Lead CRA/Project Manager
Participate in contract handling and negotiation under direction of the Lead CRA/Project Manager
Set up the Investigator Site File (ISF) and Study Master File (SMF), or support the CTA in doing so, and distribute materials to investigational sites
Collaborate with the study team on SMF maintenance
Order, ship, and reconcile clinical investigational supplies for study sites, if applicable

What we offer

competitive compensation package
comprehensive benefits
opportunity for personal and professional growth in a rewarding environment

Parttime

Senior Clinical Site Manager

iconplc

Location:
Australia , Melbourne or Sydney

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 20, 2026

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