Local Study Operations, Senior Manager Job at Amgen (Sydney)

Us Country Head, Global Site & Study Operations Senior Director

Provide strategic and operational leadership for all study and site execution wi...

Location

United States

Salary:

228624.00 - 265674.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 5 years of clinical execution experience or equivalent
Master's degree & 9 years of clinical execution experience or equivalent
Bachelor's degree & 11 years of clinical execution experience or equivalent
In addition to meeting at least one of the above requirements, you must have a minimum of 5 years' experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Job Responsibility

Provide strategic and operational leadership for all study and site execution within the assigned country or hub-and-spoke geography, ensuring delivery of the clinical portfolio in alignment with global study strategies, regulatory requirements, and Amgen quality standards
Accountable for end-to-end study, site, and site engagement execution across the assigned country or hub-and-spoke geography, delivering start-up, enrolment, retention, data quality, and patient safety outcomes in compliance with local regulations and global strategies
Provide strategic leadership for country commitments, acting as a key advisor on study feasibility, placement, and site selection, aligned to global portfolio priorities and regional strengths
Lead, line-manage, and develop the Country/Hub team, ensuring clear direction, strong performance, capability development, and succession planning to deliver portfolio and organizational objectives
Ensure adequate and timely resourcing across study delivery, site operations, and monitoring roles, working closely with global partners to match capacity and capability to portfolio demand
Drive site engagement through a clearly differentiated Amgen site experience strengthening investigator and site relationships through strong leadership, compliance, innovation, and collaboration with global study teams
Oversee country-level financial and operational management, including budgets, forecasting, vendor oversight, and efficient allocation of resources to ensure accountability and value delivery
Lead country governance and risk management, including chairing the Country Management Team (CMT),representing the country in senior governance forums, and managing risks, issues, and escalation to protect quality and delivery
Ensure regulatory compliance, inspection readiness, and continuous improvement, promoting best-practice sharing, audit readiness, and adherence to ICH-GCP, SOPs, and local regulatory requirements.

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

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

Clinical Operations Senior Project Manager

The Clinical Operations Project Manager ensures the oversight of the activities ...

Location

United States , San Mateo

Salary:

147817.00 - 175014.00 USD / Year

Dompé

Expiration Date

Until further notice

Requirements

Bachelor’s/Master’s Degree in Pharmacology, Biotechnology or related scientific discipline
7-12 years of experience in similar roles, preferably in the Pharmaceutical/Life-science sector
Project Management Certification is preferred
Languages: Italian English (fluent)
Knowledge of the main productivity and collaboration tools (Google Workspace, MS Office)
Knowledge of GCP/ICH phase I-IV clinical trials and observational studies
Knowledge of research and clinical trial methodologies
Knowledge of CRO industry
Knowledge of Project Management
Knowledge of Pharmaceutical sector

Job Responsibility

Supervises the CRO activities in all the study conduct phases (start-up, maintenance, study closure)
Is responsible to coordinate and drive in a functional matrix model the multidisciplinary team assigned to each of the company clinical trials
Is involved in the CRO process selection in compliance with current company SOPs
Is responsible for set-up and progress of the study according to the company current standards/regulation and ensures that committed targets are met until study completion
Collaborates with the local Medical Department and Site Engagement Manager to identify potential investigators to be included in the clinical network of Dompé
Collects and manages input to the study protocol and operational aspects of the study, participates in the planning of Investigator Meetings
Works with Local Drug Supply Management and ensures IMP is available to commence and complete assigned trial/assigned trial sites
Maintains knowledge of the study protocol to answer standard operational questions from CRAs of the CROs, sites, and internal Country/Cluster personnel
Ensures the performance of the CRO assigned to the study in order to be on time, budget and quality by collecting, analyzing and reporting detailed performance KPI dashboards
Closely collaborates in autonomy with the CRO project management team in order to ensure that anticipated study milestones and target are met and in order to put in place corrective or mitigation plans to address risks that may impact missing study objectives

What we offer

Comprehensive medical benefits
Generous vacation / holiday time off
Competitive 401(K) matching

Fulltime

Manager / Senior Manager, Field, ABM and Partner Marketing, SEA

As the Manager/Senior Manager for Field, ABM and Partner Marketing in SEA, you w...

Location

Singapore , Singapore

Salary:

Not provided

Airwallex

Expiration Date

Until further notice

Requirements

7+ years of B2B marketing experience with significant time in field marketing, partner marketing and ABM
proven success driving pipeline and revenue influence in Southeast Asia within fintech, payments or B2B SaaS
proven success building end-to-end ABM programs (1:1, 1:few, 1:many) with Sales alignment on account selection, insights, and measurement
track record of designing and executing high-impact field programs and partner co-marketing that deliver measurable pipeline and expedite deal cycles
strong leadership and stakeholder management
experience leading a small team and influencing senior Sales and Partnerships leaders
data-driven operator with mastery of marketing and sales tech stacks: Salesforce plus Marketo/HubSpot, ABM/intent platforms (e.g. Demandbase), webinar/event tools and analytics
excellent written and verbal communication in English
deep understanding of SEA market dynamics and how to localize GTM by country
strategic thinker who is also hands-on

Job Responsibility

Own the SEA field, ABM and partner marketing strategy and calendar aligned to regional revenue, pipeline and account coverage targets
build and run ABM programs (1:1, 1:few, 1:many) for priority enterprise and mid-market accounts across key verticals (e.g., eCommerce, SaaS, manufacturing, etc), in tight partnership with Sales on account selection, insights, value propositions and multi-threaded plays
design and execute localized field initiatives (executive roundtables, flagship events, conferences, webinars, customer meetups) that create net-new demand, accelerate active opportunities and strengthen customer advocacy
lead partner marketing with strategic alliances and channels (e.g., platforms, PSPs, ISVs, banks, networks), including co-marketing plans, MDF management, joint value propositions, co-branded campaigns, partner enablement and partner-sourced/influenced pipeline
personalize content and messaging by account, segment and market
commission and localize case studies, customer stories and thought leadership relevant to SEA buyers
orchestrate multi-channel execution across owned, earned and paid (email, events, digital, social, PR, SDR plays, website, intent and retargeting) to maximize reach and conversion
set and track KPIs for pipeline, opportunity creation, velocity, ACV, partner-sourced/influenced revenue, event ROI and program ROI
build dashboards with Marketing Ops and Sales Ops in Salesforce and MAP/ABM tools
manage regional budget, vendors and agencies

Fulltime

Country Clinical Trial Manager / Local Trial Manager

Register your interest for future opening with us as a Local/Country Clinical Tr...

Location

Italy

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum of 5 years of relevant end to end clinical trial management experience
Experience with customization or localisation of patient facing documents is essential
Excellent leadership, communication, and organizational skills. Able to multi-task under limited direction and on own initiative
M.S/M.A/Ph.D or B.A/B.S/nursing degree is essential
Prior and demonstrable experience working at a senior level within Study start up preferred

Job Responsibility

Regional/Country/Study level implementation of Start-up and Site Activation Plans
Responsible for country/study level Recruitment Strategy
Responsible to support the development of study level plans
Communication with the local team and internal stakeholders and CRO partner as applicable and as listed above to ensure efficient and timely study delivery of the agreed plans
Responsible for study and/or country vendor management and oversight including follow up and coordination of vendor deliverables
The Country Study Operational Manager will be able to work independently and exercise their own judgement

Senior Manager, Inspection Management

Location

United States , Cambridge

Salary:

130800.00 - 209400.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

BS/BA, MS or PhD and a minimum of 10, 8, 6 years’ experience, respectively, in Biotech, Pharma or Clinical Research Organization.
Knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable international GxP regulations, guidelines and local legislation.
Knowledge of relevant FDA, EU, guidance for computerized systems is a plus.
Experience with inspection coordination and logistical planning for regulatory authority inspections.
Experience with work in the Regulatory Intelligence area.
Experience developing responses to regulatory authority inspection findings.
Experience working with CROs, vendors, and relationship management.
Leadership skills with ability to effectively organize and execute tasks
Ability to interact effectively with all levels within the organization.
Ability to work both independently and in a team environment.

Job Responsibility

Build and maintain strong and productive relationships with key stakeholders within R&D to support the successful and compliant execution of Moderna regulatory inspection activities.
Maintain in-depth knowledge of governmental regulations affecting GCP, GVP, GLP in the drug development process.
Plan, and coordinate GCP, GVP, GLP, GCLP regulatory authority inspections (routine, directed or submission driven) and the pre-inspection request process.
Coordinate and manage inspection readiness and preparation activities such as inspection management trainings, mock inspection interviews, mock inspections, site risk assessments and clinical site inspection preparation visits in preparation for regulatory authority inspections.
Provide guidance and direction in development of responses to observations resulting from inspections of Moderna’s R&D programs.
Ensure any critical and major inspection findings have appropriate Corrective and Preventative Actions (CAPA) and are tracked to completion and verification of effectiveness.
Lead and manage post-inspection lesson’s learned sessions, ensuring all actions are tracked to completion.
Contribute to and maintain inspection management plans, trainings, and strategies for the R&D Quality inspection management program.
Review and provide input into study team inspection preparation activities, storyboards, etc.
Collaborate with industry through benchmarking of regulatory activities that may influence regulatory inspection activities and strategies.

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras

Fulltime

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

Director Global Site & Study Operations

In this vital role, you will provide strategic and operational leadership for st...

Location

United Kingdom , Uxbridge; London; Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Clinical trial execution experience and previous people leadership managing teams, projects, or resources
Previous experience in life sciences or a related field, including biopharmaceutical clinical research
Experience working with or overseeing clinical research vendors (e.g., CROs, central labs, imaging)
Strong experience leading clinical operations across a country or region, with knowledge of local regulatory requirements

Job Responsibility

Owning end-to-end study and site execution, including start-up, enrollment, retention, data quality, and patient safety
Advising on country commitments, feasibility, site selection, and study placement aligned with portfolio priorities
Leading, developing, and resourcing country or hub teams to meet current and future portfolio needs
Driving strong investigator and site engagement through a differentiated Amgen site experience
Managing country-level budgets, forecasting, and vendor performance to ensure efficient use of resources
Leading country governance and risk management, including chairing the Country Management Team and representing the country in senior forums
Ensuring regulatory compliance, inspection readiness, and continuous improvement, promoting best-practice sharing, audit readiness, and adherence to ICH-GCP, SOPs

What we offer

Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

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Local Study Operations, Senior Manager

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