Clinical Study Lead Job at iconplc (Boston)

Scrum Master – Clinical Study Design and Analysis

The Scrum Master is a leader and coach who facilitates team events, processes, a...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree OR Bachelor’s degree with 6 - 8 years of experience in Computer Science, Business, Engineering, IT or related field
Strong understanding of Agile methodologies, particularly the Scaled Agile Framework (SAFe)
Prior experience with Agile project management tools, such as Jira, Confluence and Jira Align
Experience in guiding teams through Agile events and ensuring adherence to SAFe practices and behaviors
Excellent problem-solving skills and a passion for tackling complex challenges with data
Collaborative spirit and effective communication skills to work seamlessly in a cross-functional team

Job Responsibility

Lead and manage product delivery using agile frameworks and techniques
Lead and facilitate agile events including stand-ups, sprint & PI planning, reviews, retrospectives, demos and backlog refinement meetings to promote team collaboration
Advise on Scaled Agile Framework (SAFe) events, including Program Increment (PI) Planning, Scrum of Scrums, and Inspect & Adapt workshops
Collaborate with cross-functional teams to identify business requirements and develop solutions that meet customer needs
Work with Product Owners, Product and Solution Management, and stakeholders to ensure strategy and execution alignment
Help the scrum teams achieve delivery acceleration focused on business outcomes by reaching higher levels of scrum maturity
Identify, escalate, and manage risks and dependencies across Teams / ART to ensure that they are addressed in a timely manner
Coordinate with services and support to schedule resolution of issues with released products
Foster a culture of continuous improvement within the Teams / Agile Release Train (ART) by leading retrospectives and encouraging innovation
Monitor and report on the progress of the Team / ART, ensuring transparency and alignment with solution objectives

Fulltime

Clinical Study Specialist

Clinical Study Specialist ICON plc is a world-leading healthcare intelligence a...

Location

United States , Basking Ridge

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Must have a Bachelor's Degree
Must have a minimum of 2 years industry related work experience
Experience supporting global trials (NA, LAM, EU, APAC, India)
Experience working in TMF, CTMS, Sharepoint
Excels in written and verbal communications
Self-starter, can work independently with minimal oversight, solution-oriented
ICF review experience
General competency: powerpoint/excel skills, meeting minutes
Vendor management/oversight experience a plus
Must be open to hybrid office/home based in Warren NJ, Armonk NY or Cambridge MA

Job Responsibility

Organizes and delivers analyzable reports and metrics to the clinical study lead
Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
Collates data for assessments such as feasibility and site selection and reviews site usability database
Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
Collates materials for training and investigator meetings
Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)

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

Clinical Study Specialist

Clinical Study Specialist (office based). ICON plc is a world-leading healthcare...

Location

United States , Boston; Basking Ridge, NJ

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Must have a Bachelor's Degree
Must have a minimum of 2 years industry related work experience
Experience supporting global trials (NA, LAM, EU, APAC, India)
Experience working in TMF, CTMS, Sharepoint
Excels in written and verbal communications
Self-starter, can work independently with minimal oversight, solution-oriented
ICF review experience
General competency: powerpoint/excel skills, meeting minutes
Vendor management/oversight experience a plus
Must be open to hybrid office/home based in Warren NJ, Armonk NY or Cambridge MA

Job Responsibility

Organizes and delivers analyzable reports and metrics to the clinical study lead
Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
Collates data for assessments such as feasibility and site selection and reviews site usability database
Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders)
Collates materials for training and investigator meetings
Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)

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

Lead Clinical Research Associate

Lead CRA - Ophthalmology ICON plc is a world-leading healthcare intelligence an...

Location

United States

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences, nursing, pharmacy, or a related field
Advanced degree preferred
Extensive experience as a Clinical Research Associate within the pharmaceutical, biotech, or CRO industry, with a proven track record of managing complex clinical trials
In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes
Strong leadership and mentoring skills, with the ability to manage and motivate CRAs and site staff effectively
Excellent communication, organizational, and problem-solving skills, with a proactive approach to managing site performance and resolving issues

Job Responsibility

Leading site management activities, including site selection, initiation, monitoring, and close-out visits, to ensure compliance with study protocols and regulatory guidelines
Serving as the primary point of contact for clinical sites, addressing site queries, and resolving issues to maintain site engagement and performance
Ensuring the integrity of clinical data by conducting thorough source data verification, reviewing site records, and monitoring for protocol deviations
Mentoring and providing guidance to CRAs, contributing to their professional development and supporting the consistent application of best practices across studies
Collaborating with cross-functional teams, including clinical project managers, data managers, and biostatisticians, to ensure the successful execution of clinical trials

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

Senior Manager Biostatistics (Study Lead Statistician)

How might you defy imagination? If you feel like you're part of something bigger...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and at least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Master's degree in Statistics/Biostatistics or related subject with high statistical content and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Bachelor's degree in Statistics/Biostatistics or related subject with high statistical content and at least 12 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Job Responsibility

Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs
Plan and execute statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs)
Implement, manage and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis
Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgen's statistical policies, procedures and strategies
Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product
Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation
Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications
Serve as the GBS lead on the Clinical Study Team leadership team to execute clinical trials according to the protocol, performing risk assessments and ensuring quality data collection and alignment between data collection and study objectives
Contribute to clinical publications, regulatory filing documents, reimbursement documents and other communications for product or study
Provide statistical consultancy, training, and advice within Amgen

What we offer

Vast opportunities to learn and develop within 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

Fulltime

Global Clinical Study Manager

We are seeking a highly motivated and experienced Clinical Study Manager (CSM) t...

Location

Canada , Montréal

Salary:

Not provided

AbCellera Biologics

Expiration Date

Until further notice

Requirements

Master’s degree in a relevant field, and 6+ years of demonstrated work experience as a Regional Clinical Project Manager or Clinical Study Manager
candidates with a Bachelor’s degree and 8+ years of related experience will also be considered
strong working knowledge of Good Clinical Practice (GCP), regulatory requirements, and clinical trial management
previous experience as a CRA, or experience working at clinical sites
strong organizational and project management skills, with the ability to prioritize and manage competing deadlines
bilingual with excellent communication skills, both written and verbal, and have the ability to collaborate effectively with internal teams, external vendors, and clinical investigators
proficient in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software

Job Responsibility

Overseeing the global strategy of clinical trials, including study planning, execution, monitoring, and close-out
ensuring clinical studies are conducted in accordance with the approved protocol, Good Clinical Practice (GCP), and applicable regulations
acting as the primary Sponsor contact for Global CRO Project Directors and Global functional leads
partnering with Clinical Project Managers (CPMs) to translate global recruitment targets into country-specific execution plans
developing and reviewing study plans, protocols, and related documents, while overseeing site selection, feasibility assessments, and the development of study materials
ensuring studies adhere to regulatory requirements and ethical standards, handling regulatory inspections and audits, and implementing corrective actions when necessary
developing and managing project timelines, milestones, and budgets, ensuring all deliverables are met within the agreed-upon timeframe and budget
identifying potential risks to the study, developing mitigation strategies, and taking appropriate action to resolve issues as they arise during the course of the study
overseeing the collection, analysis, and reporting of clinical trial data, ensuring data integrity and quality, accurate data handling, and compliance with data protection regulations
monitoring and ensuring the safety and welfare of study participants by adhering to safety reporting guidelines and promptly addressing any safety concerns

What we offer

equity
annual bonus dependent on team and company performance
a 6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
annual vacation
opportunity for flexible work arrangements
professional development opportunities
comprehensive health benefits
scientific and technical mentorship

Fulltime

Manager Biostatistics (Study Lead Statistician)

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN)...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

MSc or PhD in Statistics, Biostatistics, or related field
5 - 9 years of total experience
~3–5 years relevant industry experience
Proven ability to apply statistical methods in clinical development

Job Responsibility

Provide statistical contributions, review, and quality control of study design documents, including Key Design Elements (KDE) and protocols
Serve as the GBS lead on the Clinical Study Team leadership team to execute clinical trials according to the protocol, performing risk assessments and ensuring quality data collection and alignment between data collection and study objectives
Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation
Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications
Ensure statistics sections of the TMF are maintained and up-to-date
Communicate effectively with internal and external stakeholders regarding study-specific findings, analysis, and insights
Contributes to defining signal detection threshold
Manages self and collaborates closely with peers to ensure timely and quality deliverables
Reviews deliverables from external suppliers for quality
Staying abreast of the latest developments in the field of statistics in drug development and contribute to scientific advances in the field

What we offer

Vast opportunities to learn and develop within 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

Clinical Study Manager

Lead global rare‑disease trials that shape the future of patient care through ex...

Location

Sweden , Stockholm

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

University degree in Life or Health Sciences
Extensive knowledge of the clinical study process, including planning, conducting, and reporting multicenter international studies
Proven ability to lead multidisciplinary teams, with strong team-building, negotiation, and conflict resolution skills
Experience managing global clinical outsourcing and working with external service providers
High level of proactivity, commitment, and energy
Strong leadership, coaching, and interpersonal skills
Excellent problem-solving abilities and a customer-oriented mindset
Strong organizational and multitasking skills
Proficient in written and oral communication in English

Job Responsibility

Build relationships with investigators, study site personnel, external service providers (ESPs), and other stakeholders to ensure operational feasibility and understanding of patient needs
Lead and manage cross-functional clinical study teams, ensuring objectives and responsibilities are met
Oversee all clinical study activities, ensuring adherence to timelines, budgets, and quality standards
Ensure a quality database lock and completion of the Clinical Study Report
Identify and document risks related to clinical study activities and deliverables
Set up and maintain clinical tracking tools and study contact lists throughout the study lifecycle
Forecast and manage study budgets and contracts
Coordinate activities related to Investigational Medicinal Products, including ordering, labeling, distribution, and expiry date extensions
Ensure delivery and proper archiving of key clinical study documents
Define the scope of work for ESPs and oversee their performance, ensuring compliance with applicable guidelines and regulations

Select Country

Clinical Study Lead

Job Responsibility

Requirements

What we offer

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