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

Senior Clinical Site Manager

Senior Clinical Site Manager (SCRA) – Home-Based | Adelaide or Melbourne | Rare ...

Location

Australia , Melbourne

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Experience as a CRA II or Senior CRA within a CRO, biotech, or pharmaceutical environment
Strong site-facing experience with proven ability to build and maintain relationships
Excellent problem-solving skills and ability to think creatively to overcome recruitment challenges
High attention to detail with experience reviewing data and identifying site issues
Outstanding communication skills with the ability to adapt style across different audiences
Solid knowledge of ICH-GCP and clinical trial processes
Ability to work independently in a fast-paced, global environment

Job Responsibility

Build, develop, and maintain strong relationships with investigators and site staff
Lead all aspects of site management, including selection, initiation, monitoring, and close-out visits
Identify site performance trends and proactively address recruitment or operational challenges
Review data and site metrics to identify risks and implement solutions
Act as the primary point of contact for study sites
Support study delivery through collaboration with Project Managers, vendors, and internal teams
Contribute to study start-up activities, documentation, and regulatory submissions
Ensure studies remain audit and inspection ready at all times
Drive innovative approaches to improve site engagement and patient recruitment

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

Parttime

Senior Manager, Site Engagement, Sponsor Dedicated

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

Location

United States , LOS ANGELES, COLORADO, CALIFORNIA, ARIZONA, WASHINGTON

Salary:

133736.00 - 167170.00 USD / Year

iconplc

Expiration Date

Until further notice

Requirements

Detailed understanding of all aspects of clinical protocol design and implementation, clinical site monitoring as well as overall global drug development
Expert knowledge of clinical development (principles and concepts as well as regulatory environment e.g. ICH GCP and applicable regional/local regulations)
Oncology and/or Neurology and/or Immunology TA experience desired
Substantial (8+ years) experience in clinical operations in a CRO, pharma or biotech company including site management/oversight, and site-level clinical study conduct
Strong communication skills (verbal, written and listening) in both native language and English
Aptitude to interpret and to integrate site performance data in prioritization of oversight activities
Ensuring compliance with applicable T&E Policy requirements
Role requires domestic and international travel up to 50% of time
Ability to work independently on assigned tasks or projects of increasing complexity
Capability to perform self-training incl. on therapeutic area, and synthesize the key take-away points for studies under remit

Job Responsibility

Establish and manage site relationships
Act as liaison between the company and investigational sites, building investigator and site staff awareness on client compounds
Develop and implement a plan, in collaboration with global and local teams, to raise the profile of the company and its global clinical development projects with current and potential investigators
Independently perform activities associated with the evaluation of investigational sites to build company network
Proactively work with Medical/Patient/Industry Associations to build company network and to promote company clinical trials
Develop knowledge of site capabilities and past performance to assess their potential as participating sites in client clinical trials
Ensure regular communication with local organization to align interactions with KTLs and other relevant local/regional stakeholders
Oversee site-level study start-up, conduct, and close-out activities outsourced to CRO(s) for global programs across Therapeutic Areas
Support Site Agreement negotiations, including stand-alone and Master Site Agreements
Identify trends, issues and risks across sites, and work with external vendors and internal Trial Team to resolve/mitigate those

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

Fulltime

Manager Clinical Site Planning

In this vital role, you will serve as the Manager Supply Chain Operations, leadi...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s Degree and 8+ years of supply chain, logistics, planning, or operations experience
Master’s Degree and 8+ years of relevant experience
Experience in regulated manufacturing or life sciences industry preferred
Experience managing people required
Strong experience in supply chain planning, logistics, warehouse operations, or materials management
Demonstrated people leadership experience
Hands-on knowledge of SAP or similar ERP systems (MRP, order management, inventory transactions)
Ability to manage cross-functional stakeholders in a matrix environment
Strong analytical and problem-solving skills
Excellent communication skills

Job Responsibility

Lead and develop a team of 4 Senior Associates across raw material planning, site supply chain execution, and warehouse/logistics operations
Provide clear priorities, performance expectations, coaching, and career development support
Ensure appropriate workload distribution and cross-training to maintain operational continuity
Foster a culture of accountability, compliance, and continuous improvement
Oversee raw material planning and MRP-based execution activities to ensure material readiness and uninterrupted site manufacturing operations
Provide governance over shipping, sales order management, warehouse coordination, and inventory movement activities
Ensure accurate SAP master data execution, transactional integrity, and right-first-time processing
Monitor inventory levels, material flows, and logistics execution to minimize risk, excess, and obsolescence
Ensure timely escalation and resolution of supply, logistics, or execution risks
Establish and monitor operational KPIs related to service levels, inventory accuracy, execution timeliness, and compliance

Senior Manager Clinical Operations and Strategic Alliances

The Sr. Manager, Clinical Operations and Strategic Alliances reporting to the Di...

Location

United States , Pleasanton

Salary:

173100.00 - 234100.00 USD / Year

10x Genomics

Expiration Date

Until further notice

Requirements

An Advanced degree (M.S., PharmD, Ph.D., M.B.A.) in a Life Science, Clinical, or related field is required
8+ years of relevant industry experience with 4-5 years of experience in Clinical Operations and Alliance / Program Management within the diagnostics, biotechnology, or pharmaceutical industry
Direct experience managing research studies involving large numbers of patient samples and complex molecular testing or biomarkers
Deep understanding of clinical study execution, site management, and the complexities of clinical sample logistics and chain of custody
Direct experience in managing high-value strategic alliances and driving value through the successful execution of collaborative research, development, or commercialization agreements
Demonstrated ability to manage competing priorities, swiftly resolve complex operational problems, and drive tangible results

Job Responsibility

Study Execution: Manage the operational execution of large-scale, longitudinal clinical research studies according to established agreements with academic institutions
Timeline & Risk Management: Own and drive clinical research study timelines, deliverables, and operational plans ensuring adherence to sampling schedules
identify operational risks regarding enrollment, setup, or logistics early, implementing mitigation strategies to maintain study integrity
Sample Logistics & Chain of Custody: Establish and enforce auditable procedures for sample collection, tracking, and chain of custody, ensuring compliant transport from clinical sites to 10x Genomics laboratory
Budget & Resource Oversight: Manage the study budgets, including the oversight of reimbursement, equipment provisioning, and consumables provided to partner sites
Regulatory & Quality Compliance: Ensure all study activities comply with IRB protocols, patient consent requirements, and GCLP/CLIA standards where applicable
Partnership Management: Manage a diverse, high-value portfolio of academic collaborations and strategic partnerships to ensure all projects and agreements track toward established milestones and outcomes
Governance Management: Ensure transparent communication, effective decision-making, and rapid conflict resolution between internal teams and external partners
lead and facilitate Joint Steering Committees (JSCs) and cross-functional governance meetings as needed
Stakeholder Management: Act as the primary liaison between internal teams and key stakeholders at relevant academic institutions and industry partners to foster strong, collaborative relationships that drive engagement and performance

What we offer

Equity grants
Comprehensive health and retirement benefit programs
Annual bonus program or sales incentive program
Generous time off
Competitive and comprehensive health benefits package
Easy-to-use benefits that promote wellbeing and make your life easier
Family friendly policies like parental leave
Award-Winning Workplace

Fulltime

Senior Manager, Clinical Marketing – Emerging Procedures

The Senior Manager, Clinical Marketing is responsible for defining and executing...

Location

United States , Austin

Salary:

Not provided

FOCAL ONE

Expiration Date

Until further notice

Requirements

Strong cross-functional experience working across Clinical, Sales, Marketing, and medical teams within healthcare or medical technology environments
Solid understanding of procedural medicine workflows and clinical environments
Proven ability to position and communicate the clinical and patient value of advanced procedures
Comfort with data-driven storytelling using clinical outcomes and peer-reviewed evidence
High attention to detail, quality, and compliance with company and regulatory standards
Demonstrated capability to manage multiple concurrent projects in a complex, matrixed organization
Fluent in English
Excellent communication, presentation, project management and negotiation skills with the ability to influence decision-makers and stakeholders at all levels
Adaptable and able to thrive in a fast-paced environment with a continuous improvement mindset
Proven leader who enjoys building and managing a high performing team

Job Responsibility

Develop and execute emerging procedure strategy
Lead the development of procedure-specific clinical marketing strategies
Translate strategy into actionable annual and quarterly execution plans
Operationalize global initiatives such as KOL development, clinical value definition, and economic value framing
Identify and cultivate surgeon champions and potential key opinion leaders
Support peer-to-peer education models including live case observations, proctoring, and early adopter programs
Develop structured adoption pathways including centers of excellence, early adopter sites, and local or regional workshops
Manage Focal One’s clinical marketing presence at key specialty society meetings and academic conferences
Plan and execute symposia, peer-to-peer courses, and live or recorded procedural education programs
Collaborate with specialty societies and academic partners to support clinical awareness, alignment, and consensus development

Fulltime

Senior Clinical Trial Manager

Sr Local Trial Manager – Solid Tumor Oncology - Home Based (US). ICON plc is a w...

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
Solid Tumor Oncology experience required
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
Good written and oral communication skills as appropriate

Job Responsibility

Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams
Manages and oversees Central IRB and other local vendors including set up of vendor purchase orders, invoice review and approval, and change-orders
Execution of local milestones from feasibility through study close out
Resourcing of country-level roles, including support with transitions
Inspection Readiness and AQR at the country level
Close collaboration with assigned Local Trial Managers (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs)
Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL)
Country level ad hoc meetings during any phase of the study
Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks

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
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Senior Clinical Trial Manager

Senior Local Operations Manager - Hematology Oncology - Home Based. ICON plc is ...

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
Hematology Oncology experience required
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
Proficient in speaking and writing the country language and English
Good written and oral communication skills as appropriate
To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
Owns relationships with critical site stakeholders to provide a voice for the site to the client's teams
Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report
Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget
Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial
Focuses on investigator engagement through timely follow up with sites
Drive study compliance by maintaining and updating trial management systems
Contribute to site level recruitment strategy and contingency planning and implementation
Delivers competent vendor management at the country level to support the study
Ensures high standards for study monitoring by conducting quality local trial team meetings

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
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Senior Clinical Trial Manager

Senior Local Operations Manager - Oncology - Home Based. ICON plc is a world-lea...

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
Solid Tumor Oncology experience required
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
Proficient in speaking and writing the country language and English
Good written and oral communication skills
To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams
Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report
Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs
Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial
Focuses on investigator engagement through timely follow up with sites
Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress
Contribute to site level recruitment strategy and contingency planning and implementation
Delivers competent vendor management at the country level
Ensures high standards for study monitoring by conducting quality local trial team meetings

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
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

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Senior Clinical Site Manager

Job Description

Job Responsibility

Requirements

What we offer

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