Clinical Trial Coordinator Job at AbCellera Biologics (Montréal)

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

Clinical Site Associate / Clinical Trial Associate

Clinical Site Associate / Clinical Trial Associate, Office-based (hybrid) in Syd...

Location

Australia , Sydney

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences, healthcare, business, or a related field, or equivalent experience
Initial experience in clinical research, administration, or a similar regulated environment is preferred
Strong organisational skills with the ability to manage multiple tasks, priorities, and deadlines
High attention to detail and accuracy in documentation and data entry
Effective written and verbal communication skills, with a customer-focused approach to site support
Proficiency with MS Office and comfort working with electronic systems and databases
Ability to work collaboratively in a team environment and adapt to changing priorities

Job Responsibility

Supporting site activation activities, including the collection, review, and tracking of essential documents and approvals
Maintaining up-to-date site information and status in clinical trial management systems and trackers
Assisting CRAs and project teams with site communications, follow-up, and resolution of site-level queries
Coordinating logistics for site visits and meetings, including scheduling, documentation preparation, and follow-up actions
Ensuring accurate filing and maintenance of essential documents to support inspection and audit readiness
Collaborating with internal stakeholders to support timely site payment processing and issue resolution
Contributing to process improvement initiatives and sharing best practices to enhance site support efficiency

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

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

New

Senior Clinical Trial Associate

Location

United Kingdom , Reading; Cambridge

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant scientific discipline or healthcare-related field
Extensive experience in a clinical trial support role, with a solid understanding of clinical trial processes and regulatory requirements
Strong organizational and multitasking skills, with the ability to manage multiple tasks and projects effectively
Proficiency in clinical trial management systems and relevant software, with a keen eye for detail in documentation and data management
Excellent communication, interpersonal, and problem-solving skills, with the ability to work collaboratively with diverse teams and stakeholders

Job Responsibility

Providing administrative support for clinical trials, including managing documentation, coordinating meetings, and maintaining trial-related records
Assisting in the preparation and submission of regulatory documents and ensuring compliance with study protocols and regulatory requirements
Collaborating with cross-functional teams to support trial operations and resolve any issues that arise during the course of the study
Monitoring and tracking trial progress, including managing site communications and ensuring timely delivery of study materials
Building and maintaining strong relationships with site staff and other stakeholders to facilitate smooth trial operations and support overall project success

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

Fulltime

Global Clinical Trial Leader - Sponsor Dedicated - Home Based

As a part of the global Project Leadership group at Parexel, you are responsible...

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum of 5 years of relevant clinical trial management experience
Strong clinical trial project management experience
In depth understanding of project management with an emphasis on team work, to promote high performance teams
Experience in either Oncology, CNS, Immunology or Vaccines
Extensive experience in clinical trial project management across international trials
Masters Degree ideal but not essential

Job Responsibility

Accountable for the accurate planning and operational feasibility of trial timelines
and oversight of trial preparation to ensure trial team members are aligned and on track
Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring)
Verifies and provides input into the country allocation and oversees trial feasibility
Accountable for development and implementation of trial level engagement plans, recruitment planning and risk mitigation
Leads development of core trial and patient facing documents
Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements
compliance with SOPs and continuous risk monitoring/mitigation
In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting
Prepare and implement amendments of core documents, including training material updates/retraining as needed

Fulltime

Clinical Trial Site Engagement Manager

Biocomposites is an international medical devices company that engineers, manufa...

Location

United Kingdom , Wilmington

Salary:

Not provided

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific/health related discipline
A minimum of 5 years of experience in the clinical trials Pharmaceutical, Biotechnology, or CRO industry
Proven track record of success in a clinical trial environment
Good working knowledge of IHC-GCP guidelines
Experience in clinical trial operations
Strong planning and tracking skills, customer focused, well organized, detail oriented and capable of successfully managing multiple projects
Excellent time and self-management skills
Strong project management skills
Team orientation: initiative to solve problems and improve efficiency
Proficiency in MS Excel, PowerPoint and Word. MS Project

Job Responsibility

Provide operational expertise to sites throughout the clinical trial lifecycle
Support the clinical trial team to collect site feasibility information and conduct remote site qualification visits
Help implement strategies for engaging clinical trial sites and investigators to identify challenges and supporting sites to overcome them to ensure timely delivery of trials
Be a point of contact for the sites and a conduit to the clinical trials team at Biocomposites and the CRO supporting the trial
Conduct thorough feasibility assessment to evaluate the suitability of clinical trial sites
Collaborate with site investigators and study teams to gather necessary information and assess site capabilities
Support site initiation visits and collating essential documentation for site activation
Support sites with protocol specific queries and product/protocol training as required
Characterize and understand the attributes of a good clinical site versus a poor performing site
Establish and maintain relationships with the team at clinical trials sites, to maximise performance and engagement during conduct of clinical trials

What we offer

Competitive salary package and benefits
Opportunities to thrive and grow
Engaged and inclusive global teams
Team spirit & engagement

Fulltime

Clinical Trial Associate

As a part of the global Project Leadership group at Parexel, you are responsible...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

BS/BA degree or degree in healthcare field required
Direct experience supporting clinical operations activities, 1+ years in pharma/biotech company or 2+ years of experience in a CRO
Very strong foundational understanding of clinical trials, and have prior experience in the administrative aspects of clinical operations
Experience managing the TMF with a solid understanding of filing expectations at study, country, and site levels
Experience managing the CTMS, study team lists, SharePoint accesses
Taking diligent meeting agendas/minutes
Tracking and following up on action items with a fundamental understanding what goes into each action
Tracking study plans & training compliance
Maintaining ongoing systemic reviews, such as User Access Reviews, eSystems List Reviews, Global Vendor Listing Reviews
Effective written and verbal communication skills, with the ability to work collaboratively within study teams

Job Responsibility

Assist with organizing, updating and maintaining tracking systems and tools to support the conduct of clinical study from start-up to closeout
Assist with the coordination and development of study management tools, monitoring tools, study manuals and training materials and presentations
Schedule meetings, prepare and distribute meeting agendas, minutes, and follow-up action items for study teams
Set up, organize and maintain study files and shared spaces in accordance with study requirements
Coordinate and track study training
Manage study sample and supply tracking and support interactions with vendors as needed
Support the Study Management team with specific projects
Effectively communicate with study team members and in collaboration with the study team, identifies and addresses study-related issues
Perform routine quality checks on trial level documents to ensure completeness and accuracy
Supports the timely, complete and compliant archiving in the TMF

Senior Regulatory Affairs Associate - Clinical Trial Applications (CTA)

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

South Africa , Bloemfontein

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in a science discipline
Background in clinical trial management
Innitial years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa - must
Experience with clinical trial submissions in other Southern African Countries - preferred
Good level of knowledge of the CTA business in addition, an expertise/skill in cross-functional project management and planning, process optimization
IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI)
Solid analysis and synthesis capability
Solution-oriented and problem-solving skills
Customer-oriented and autonomous
Fluency in English is a must along with the local language.

Job Responsibility

Manage the local submissions (as Local Regulatory Contact - LRC) but should also be able to coordinate the regulatory submissions in all participating countries as Regulatory Lead
Regulatory submission of Clinical Trial in South Africa
Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary
May be involved in local, regional, and/or global projects

Fulltime

Select Country

Clinical Trial Coordinator

Job Description

Job Responsibility

Requirements

What we offer

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