Senior Manager, Clinical Operations/ Senior Global Trial Manager

Local Study Operations, Senior Manager

Location

Australia , Sydney

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 2 years of clinical execution experience OR Master's degree & 6 years of clinical execution experience OR Bachelor's degree & 8 years of clinical execution experience OR Associate's degree & 10 years of clinical execution experience OR High school diploma / GED & 12 years of clinical execution experience
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead the skill development of Local Study Operation Managers (LSOM's), ensuring effective trial implementation within the country and strong alignment with global strategies
Oversee the delivery of the country’s study portfolio—managing scope, timelines, and budgets—through the leadership of LSOM
Drive alignment and continuous improvement in LSOM execution by integrating best practices, promoting digital innovation, and facilitating robust knowledge sharing across the team
Ensure the successful delivery of the study portfolio assigned to LSOMs
Oversee LSOMs’ fulfillment of responsibilities throughout the assigned country portfolio, from feasibility through to study close-out
Monitor portfolio progress, provide risk and quality oversight, and support issue escalation and resolution for LSOMs
Manage LSOM and LSOM vendor performance to guarantee high-quality study execution, serving as the primary escalation point for local study challenges, driving solutions, and ensuring portfolio targets are met within the country
Mentor, train, and support the professional development of LSOMs to prepare them for managing complex trials
Build and maintain a high-performing team
Facilitate close collaboration between the study strategy team and local study teams to effectively manage the assigned portfolio

What we offer

health, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities

Fulltime

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 Clinical Research Associate - FSP

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

Location

South Korea

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
Fluent in English and in the native language(s) of the country they will work in
Extensive knowledge of clinical trial methodologies, ICH/GCP and local country regulations
Global clinical trial experience
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
Demonstrated knowledge of clinical research and development processes
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research
Demonstrated knowledge in disease and technical areas pertaining to clinical studies
Demonstrated ability to support sponsor regulatory interactions/inspections

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
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock
Serve as the primary point of contact for assigned investigator sites
Interface with the study team as needed
Partner with SCP to perform investigator site development, coaching and training of site personnel
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
Monitor site level adverse events (AEs) and serious adverse events (SAEs)
Submit all required reports, documentation, updates and tracking within required timeframes
Identify and resolve investigator site issues within required timeframes

What we offer

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

Fulltime

Senior Manager Regulatory Affairs CZ&SK

Senior Manager Regulatory Affairs CZ&SK. Czech Republic - Prague. SALARY RANGE: ...

Location

Czech Republic , Prague

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience
Degree and in-depth regulatory experience and/or related to the affiliate
Depth knowledge of affiliate legislation and regulations relating to medicinal products
English and Czech and/or Slovak language working proficiency
Good negotiation and Influencing skills
Ability to anticipate and prevent potential issues
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
Cultural awareness and sensitivity to achieve results across both regional, affiliate and international borders
Ability to manage multiple activities and set priorities
Ability to lead teams and develop effective teams

Job Responsibility

Provides affiliate regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules
Oversee the affiliate and manage a regulatory team to ensure delivery of assigned local and ELMAC Regulatory initiatives
First point of contact for interactions with local regulatory agency(ies)
Ensure that the local Regulatory staff delivers assigned local and ELMAC Regulatory initiatives across the affiliates
Represent Regulatory on the affiliate leadership team
Provide local regulatory input to support development and execution of assigned Regulatory Affairs initiatives and effective interactions with key regulatory agency(ies)
Supervise and oversight for one or more regulatory staff
Manage and liaising with distributors (if applicable)
Translates assigned global, regional and ELMAC Regulatory initiatives into local regulatory objectives where applicable
Acts as senior point of contact for local regulatory advice on commercial and medical activities within the affiliate

Fulltime

Senior Clinical Research Associate

Senior Clinical Research Associate, FSP Model, Paris, Hybrid or Home based, Prod...

Location

France , Paris

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 (4/5 years independent monitoring or more), with a proven track record of managing complex trials within a CRO or Pharma environment
Fluency in French and professional proficiency in English (mandatory for reporting and international stakeholder management)
In-depth knowledge of ICH-GCP guidelines
Proven ability to manage multiple high-priority sites and projects simultaneously, with superior organizational and problem-solving skills
Excellent communication and interpersonal skills, with the ability to influence site compliance and represent a leading global sponsor effectively
Ability to travel as required to clinical sites and should possess a valid driver's license

Job Responsibility

Independently monitor Phase II–IV clinical trials as a senior resource dedicated to a major French pharmaceutical leader, ensuring full compliance with ICH-GCP and specific sponsor SOPs
Manage clinical studies in France across multiple complex therapeutic areas including Neurology, Rare Disease, Dermatology and Oncology
Lead site qualification, initiation, monitoring, and close-out visits, providing expert oversight and ensuring the highest standards of site performance
Ensure protocol compliance, data integrity, and participant safety through rigorous source data verification and proactive site management
Build and maintain influential relationships with investigators and site personnel to drive recruitment and facilitate smooth trial operations within this exclusive partnership
Perform advanced data review and resolution of complex queries to maintain the highest quality of clinical data within the sponsor’s proprietary systems
Contribute to the preparation, review, and optimization of study documentation, including monitoring plans and clinical study reports
Oversee study documentation, regulatory submissions, and ethics/IRB approvals to ensure strict adherence to trial timelines
Drive study cost efficiency and provide proactive resolution for site-level issues to meet critical milestones for our pharmaceutical partner

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

Study Delivery Resource Management Senior Manager

Provide strategic oversight for resource planning and allocation across global c...

Location

United Kingdom , Uxbridge; London

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Proven ability to lead teams, manage complex projects or programs, and support effective resource coordination
Previous experience in Life Sciences, especially in Biopharmaceutical Clinical Research
Experience managing teams across multiple geographies
Experience overseeing CROs and other clinical vendors
Strong understanding of global clinical trial operations and resource management

Job Responsibility

Lead development of accurate, forward-looking resource forecasts and hiring plans at program, study, and country levels
Serve as the single point of accountability for equitable and strategically aligned resource allocation decisions
Develop and oversee recruitment strategies in partnership with HR and GDO SPOs
Provide leadership oversight for FSP engagement models and facilitate FMT governance
Act as a trusted liaison to senior functional leaders and country stakeholders
Lead cross-functional process improvement initiatives, integrating AI and automation where appropriate

What we offer

Vast opportunities to learn and move up and across our global organization
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

Start Up Project Manager II- FSP

The Start Up Project Manager is responsible for defining, developing and deliver...

Location

Canada

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Demonstrated clinical research experience
Demonstrated start up experience
Demonstrated project management experience
Global start up experience (Exposure across a minimum of North America, Asia and Europe) across multiple therapeutic areas
Concurrent management of complex processes within and across countries in multiple regions of the world
Technical expertise in the use of software for the management of clinical studies (enterprise project management, off the shelf and custom built) including reporting systems (dashboards with associated medium to complex data analysis)
Expert ability to comprehend status and adapt communications across a diverse audience
Perform critical path analysis across multiple related project plans, will use key performance indicators to assist in driving overall delivery to operational plan across roles
Will use generative artificial intelligence techniques in daily work
Uses risk management techniques as standard to identify and mitigate key project delivery risks

Job Responsibility

Partner with country / site feasibility specialists to incorporate up to date intelligence for the planned countries and sites into the overall start up strategy and site activation plan, most typically on studies with a medium to large country and site footprint
Partner and co-ordinate across teams responsible for regulatory submissions (local and country) and start up functions (e.g. site essential document collection, site contracts and budgets) to align country and site activities, will have ability to form a robust startup strategy and site activation plan for operationally complex studies
The SUPM is responsible for delivering site activations to plan, for the SUPM II this will generally be for studies with higher operational complexity (based on a combination of factors such study design, country and site footprint and the priority of the study)
As part of the responsibility of delivering site activations to plan the SUPM will co-ordinate with many different roles working at the study and country level to oversee progress of the study specific (e.g. Vendor set-up, investigational product supply etc.) or country specific tasks (e.g. Regulatory submissions, importer of record for supplies etc.) that need to be completed in order for site activations in turn to complete
Provide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start up activities for a study
Lead start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles with the endorsed trial optimization plan (by senior leadership)
The SUPM will work with country level start up roles to seek opportunities to accelerate site activations for their study
Accountable for quality and completeness of start up timeline plans at study, country and site level within an enterprise project management (EPM) system
Responsible for creating and overseeing the initial baseline and subsequent snapshots of timeline planning within the EPM system
In conjunction with study management roles is responsible for ensuring consistent participant compensation for sites and institutions taking part in multiple studies concurrently to eliminate knock-on impact across studies

Sr. Manager, Biobank

In this vital role you will be part of the larger corporate mission of bringing ...

Location

United States

Salary:

137365.95 - 185848.05 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree PhD OR PharmD OR MD and 3 years of industry experience in clinical trials and/or biospecimen management OR Master's degree and 6 years of industry experience in clinical trials and/or biospecimen management OR Bachelor's degree and 8 years of industry experience in clinical trials and/or biospecimen management

Job Responsibility

Serve as the senior escalation authority for complex informed consent and biospecimen governance matters, providing final interpretation of participant intent and partnering with Institutional Review Boards and Ethics Committees to enable compliant and efficient study start-up
Establish and maintain the enterprise governance framework for informed consent templates related to biospecimen collection, retention, and reuse, ensuring alignment across clinical programs and evolving global regulatory expectations
Lead and develop a multi-layered operating model across internal staff and FSP partners, ensuring appropriate segmentation of transactional, rules-based, and judgment-driven work while driving overall operational performance
Identify systemic gaps across the biospecimen lifecycle and lead cross-functional initiatives to implement scalable solutions that improve cost efficiency, turnaround time, and governance quality
Own the strategic direction of biobank operations, including inventory optimization, long-term storage and disposition strategy, and advancement of key transformation initiatives aligned with the future-state operating model
Set vendor and supplier strategy for long-term storage and biobank services, including selection, performance oversight, and alignment with enterprise cost and capacity planning goals
Provide executive oversight of biospecimen transfer activities supporting in-licensing and out-licensing, ensuring risk mitigation, compliance, and seamless integration with broader R&D transactions
Ensure inspection readiness and governance oversight for nonclinical biospecimen management under GLP, reinforcing quality systems and regulatory compliance expectations
Define and drive capability-building strategy across the biobank function, including training frameworks, escalation pathways, and role clarity to support the evolving governance and program leadership model

What we offer

A 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
Flexible work models where possible

Fulltime

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Senior Manager, Clinical Operations/ Senior Global Trial Manager - FSP

Job Description

Job Responsibility

Requirements

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