Clinical Study Manager Job at Proclinical (Stockholm)

Clinical Trial Manager/ Sr Clinical Trial Manager (PM/ Sr PM)

Clinical Operations Lead - Early Development Oncology. ICON plc is a world-leadi...

Location

United States , Raleigh, Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BS/BA degree or a relevant degree with strong emphasis on science, or equivalent experience
Minimum of five years of relevant experience in the biopharmaceutical industry or other relevant clinical research experience, with a focus on skills and competencies
Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health
Prior experience in assisting the conduct and management of multinational clinical trials is preferred
Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously
Experience in oncology studies required (phase I preferred)

Job Responsibility

Participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations department
Act as preliminary liaison for study sites to convey study information, answer questions and in accordance with the escalation pathway
Develop relationships with investigational sites, HCPs, and institutions to enhance conduct of the trial
Monitor study-specific timelines and key deliverables
focus on management of all relevant external vendors (e.g., Monitoring, Sample management, IVRS, Laboratory, etc)
Participate as a member of the multi-disciplinary trial(s) team
Participate in coordinating efforts with internal Pharmacovigilance, and safety group as needed
Participate in data review and discrepancy resolution as needed
Assist in the development of the IP and co-medication strategy (quantities, labels, depots, tracking, etc.) working closely with other departments
Plan and organize meetings with team support (e.g., investigator/coordinator meetings, DMC, SMC, safety call, etc.) as appropriate

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

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

Clinical Laboratory Study Manager

Parexel FSP is looking for a Clinical Laboratory Study Manager. The candidate ca...

Location

Argentina

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum of 6 years clinical research experience with academic, Contract Research Organization, pharmaceutical or biotech industry
Working knowledge of clinical drug development process and clinical databases, as well as ICH, GCP guidelines, and US FDA and/or local country regulations as applicable
Requires bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience. Biology or equivalent major preferred
Fluent in speaking/writing English
Proficiency in Microsoft Office applications, including strong excel knowledge, as well as relevant role specific systems
Proficiency in Python, R, Perl, SQL or other programming languages, as well as familiarity with APIs and Linux/Unix environments, if acting as programming lead for supplies and laboratory operations
Strong project management and organization skills in a matrix environment
Analytical and problem-solving experience
Excellent written and verbal communication skills
Effective communication and interpersonal skills, with proven ability to build relationships internally and externally

Job Responsibility

Participates in cross-functional study team meetings and workstreams to support the delivery of the precision medicine strategy for the assigned studies
Supports clinical study teams as subject-matter expert for technical and operational matters related to sample management and testing, including anticipating challenges, managing risk across projects and responding queries from internal and external stakeholders
Works with clinical study teams on the development and review of sample-related sections of study-specific documents such as the clinical protocol, Informed Consent Forms (ICFs) and sample management guidelines
Supports project management and study set-up teams in the creation and validation of specialty laboratory databases for data collection and sample kit tracking
Manages all activities related to biosample process planning and execution, including storage, shipping, and data transfer throughout the study lifecycle
Oversees the acquisition and testing of clinical trial samples designated for biomarker research (including human tissue, whole blood, plasma, serum, etc.), liaising with relevant stakeholders to assess biosample vendors, review proposals/bids, and define contractual scope
Forecasts operational costs and timelines, and manages budgeting, invoicing and reporting for study-related operations
Works closely with data management and biostatistics leads to determine how biomarker data will be captured, blinded, transferred and reported for clinical trials
Develops and reviews data transfer specifications and related documents
Provides guidance and training to clinical teams and investigative sites regarding collection, storage and shipment of biospecimens to ensure compliance with the clinical protocol

Clinical Laboratory Study Manager

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum of 6 years clinical research experience with academic, Contract Research Organization, pharmaceutical or biotech industry
Working knowledge of clinical drug development process and clinical databases, as well as ICH, GCP guidelines, and US FDA and/or local country regulations as applicable
Requires bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience. Biology or equivalent major preferred.
Strong project management and organization skills in a matrix environment
Analytical and problem-solving experience
Excellent written and verbal communication skills
Effective communication and interpersonal skills, with proven ability to build relationships internally and externally
Fluent in speaking/writing English
Proficiency in Microsoft Office applications, including strong excel knowledge, as well as relevant role specific systems
Proficiency in Python, R, Perl, SQL or other programming languages, as well as familiarity with APIs and Linux/Unix environments, if acting as programming lead for supplies and laboratory operations

Job Responsibility

Participates in cross-functional study team meetings and workstreams to support the delivery of the precision medicine strategy for the assigned studies
Supports clinical study teams as subject-matter expert for technical and operational matters related to sample management and testing, including anticipating challenges, managing risk across projects and responding queries from internal and external stakeholders
Works with clinical study teams on the development and review of sample-related sections of study-specific documents such as the clinical protocol, Informed Consent Forms (ICFs) and sample management guidelines
Supports project management and study set-up teams in the creation and validation of specialty laboratory databases for data collection and sample kit tracking
Manages all activities related to biosample process planning and execution, including storage, shipping, and data transfer throughout the study lifecycle
Oversees the acquisition and testing of clinical trial samples designated for biomarker research (including human tissue, whole blood, plasma, serum, etc.), liaising with relevant stakeholders to assess biosample vendors, review proposals/bids, and define contractual scope
Forecasts operational costs and timelines, and manages budgeting, invoicing and reporting for study-related operations
Works closely with data management and biostatistics leads to determine how biomarker data will be captured, blinded, transferred and reported for clinical trials
Develops and reviews data transfer specifications and related documents
Provides guidance and training to clinical teams and investigative sites regarding collection, storage and shipment of biospecimens to ensure compliance with the clinical protocol

LSOM Line Manager (Local Study Operations Line Manager)

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part...

Location

Taiwan , Taipei

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
In addition to meeting at least one of the above requirements, you must have a 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 Operations Managers, 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
Working in close partnership with the Country GSSO Head, help foster, enhance, and sustain an optimal clinical research environment that supports global R&D objectives
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

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

Fulltime

Project Manager III - NCCT Study Feasibility Manager

The National Center for Clinical Trials (NCCT) is designed to serve as an innova...

Location

United States , Winston Salem

Salary:

38.20 - 57.30 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Master's degree related to project management and evaluation, such as Epidemiology, Public Health, Psychology, or Sociology
Four years of relevant administrative and medical experience in research projects or other health-related activities
Two years' experience in a supervisory capacity
Must have 4+ years managing projects and/or processes
Must have 2 years in a supervisory capacity
Must have 5+ years of experience working with clinical trials
Working knowledge of clinical trial management systems and electronic medical records
Detailed understanding of clinical trial operations and challenges from the site perspective
Experience in leading teams and in decision-making role(s)
Excellent written and verbal communication skills

Job Responsibility

Assesses overall feasibility of clinical trials as they are presented to NCCT
Works with informatics team to analyze availability of patient cohorts and potential subject accrual challenges
Reviews potential trial opportunities and develops / distributes study summary of information
Works with service line and site leaders to assess scientific merit of trials, feasibility, site readiness and resources
Evaluates all potential sites for activation
Works with Recruitment, Call Center and Data Coordinating Center to develop patient matching, recruitment and study conduct plans
Reviews ongoing and upcoming trials and works with leadership to prioritize competing trials
Works with IT team to assess IT needs for trials
Facilitates and attends site initiation visits
Responsible for outreach to applicable physicians, care teams, etc to gain valuable information

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Fulltime

Project Manager III - NCCT Study Feasibility Manager

The National Center for Clinical Trials (NCCT) is designed to serve as an innova...

Location

United States , Winston Salem

Salary:

38.20 - 57.30 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Master's degree related to project management and evaluation, such as Epidemiology, Public Health, Psychology, or Sociology
Four years of relevant administrative and medical experience in research projects or other health-related activities
Two years' experience in a supervisory capacity
Must have 4+ years managing projects and/or processes
Must have 2 years in a supervisory capacity
Must have 5+ years of experience working with clinical trials
Working knowledge of clinical trial management systems and electronic medical records
Detailed understanding of clinical trial operations and challenges from the site perspective
Experience in leading teams and in decision-making role(s)
Excellent written and verbal communication skills

Job Responsibility

Assesses overall feasibility of clinical trials as they are presented to NCCT
Works with informatics team to analyze availability of patient cohorts and potential subject accrual challenges given competing trials
Reviews potential trial opportunities and develops / distributes study summary of information for functional areas and leaders to analyze potential participation
Works with service line and site leaders to assess scientific merit of trials, feasibility, site readiness and resources
Evaluates all potential sites for activation
Works with Recruitment, Call Center and Data Coordinating Center to develop patient matching, recruitment and study conduct plans
Reviews ongoing and upcoming trials and works with leadership to prioritize competing trials
Works with IT team to assess IT needs for trials
Facilitates and attends site initiation visits
Responsible for outreach to applicable physicians, care teams, etc to gain valuable information

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Fulltime

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

Parexel are currently recruiting for an experienced Global Study Operations Mana...

Location

Italy; United Kingdom , Remote; Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum of 7 years of relevant clinical trial management experience
Global trial management experience is essential
Experience managing CRO outsourced studies 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

Accountable for the end-to-end clinical trial delivery
Providing operational leadership and oversight of cross-functional deliverables
Leading a cross functional trial team to build and deliver the trial operational plan
Responsible for leading the Cross functional trial team to influence and execute delivery of the operational plan and for end-to-end trial execution
Accountable for overall trial delivery, budget, timelines, quality, and milestones
Oversight of all aspects of CRO/vendor identification, set up, statement of work creation, budget oversight and performance (KPI’s and metrics)
Proactively ensure that trial deliverables and milestones are met according to corporate and study-level goals
Identify risks and ensure mitigations and contingencies are being initiated and followed through
Ensure trial Is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes
Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits

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Clinical Study Manager

Job Description

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