Global Clinical Trial Assistant Job at iconplc (Paris)

Clinical Trial Assistant

Clinical Trial Assistant (CTA) - Hybrid - Bulgaria. ICON plc is a world-leading ...

Location

Bulgaria , Sofia

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
Experience in management of clinical trial and/or regulatory documents
Knowledge of application used in the clinical trials: eTMF, CTMs, etc
Knowledge of clinical trial processes, regulations and guidelines
Excellent organizational and communication skills
Ability to work collaboratively in a fast-paced environment with attention to detail

Job Responsibility

Maintain / develop global tracking spreadsheets for study-related documents, data, activities and prepare site supportive material
Assist study team with the preparation of any documents or tracking and updating information
eTMF filing, quality, maintenance, compliance and oversight
Development and delivery of sites’ ISF and eISF when utilized and act as primary point of contact for the sites and manage the Site Operations/monitor access to eISF prior to SIV
Maintain sponsor's registries and systems as required
Provide reporting to support management of clinical trials
Provide support with audit and inspection readiness activities
Perform customization and translation of documents as required
Manage Physical Archiving needs as required
Preparation of documents and communications for distribution to and collection from sites, as required

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 Trial Associate

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

China , Shanghai

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's or advanced degree in Life Sciences, Health Sciences, or a related field
Previous experience in clinical research or healthcare, preferably within the pharmaceutical, biotechnology, or CRO industry
Strong organizational and time management skills, with the ability to prioritize tasks and manage competing priorities effectively
Excellent attention to detail and problem-solving abilities, with a commitment to ensuring data accuracy, integrity, and compliance
Effective communication and interpersonal skills, with the ability to collaborate cross-functionally and build strong relationships with study teams and clinical sites

Job Responsibility

Assist in the planning, execution, and monitoring of clinical trials, ensuring adherence to protocol requirements, regulatory guidelines, and industry standards
Coordinate study activities including site initiation, patient recruitment, data collection, and monitoring visits to ensure timely and accurate data collection and documentation
Collaborate with cross-functional teams including Clinical Operations, Data Management, and Biometrics to support the successful execution of clinical trials
Maintain comprehensive study documentation and records, ensuring compliance with applicable regulations and standard operating procedures
Support study close-out activities including data cleaning, analysis, and preparation of clinical study reports

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 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

Clinical Trial Manager

We are seeking a hands-on Clinical Trial Manager to oversee clinical trial opera...

Location

United States , Basking Ridge

Salary:

100.00 - 120.00 USD / Hour

Solomon Page

Expiration Date

Until further notice

Requirements

5+ years of clinical trial coordination/management experience
Global clinical trial experience required
Strong understanding of drug development processes
Strong project management and organizational skills
In-depth knowledge of FDA and ICH GCP guidelines
Excellent communication and stakeholder management abilities
Proactive, hands-on approach with willingness to wear multiple hats
Previous clinical monitoring experience
Experience with Microsoft PowerPoint
Bachelor’s degree in a science or clinical-related field required

Job Responsibility

Reviews, and may also contribute to the development of, clinical study-related documents
Helps to ensure that the study is conducted in accordance with agreed upon timelines
Prepares potential investigator site lists for study feasibility and assists with their evaluation and approval for inclusion in the study
Contributes to the planning and coordination of investigator meetings
Maintains relationships with assigned investigator sites, vendors and consultants
Ensures investigator and investigator site personnel comply with protocols
Assists in the oversight of the shipment of, and return of, clinical supplies
Maintains accurate and updated study files
Participates in the selection and oversight of external service providers
Recommends strategies for, and oversees, the execution of activities associated with clinical monitoring, safety, eligibility, enrollment, and data consistency

What we offer

Medical
dental
401(k)
direct deposit
commuter benefits

Fulltime

Clinical Trials Assistant - FSP

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

Location

Australia , North Ryde, Sydney, Macquarie Park

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Adaptable
Communicator
Collaborative
Leadership
Proactive
Problem-solver

Job Responsibility

Clinical trial related general tasks as required throughout the trial life cycle
Communicate internally with clinical trial team (e.g., CTM, CRA) and externally with clinical sites, vendors and other departments
Set up and maintenance of trial related sharing platforms e.g., Sharepoint Online
Support trial document management processes for Clinical Documentation System (Veeva Clinical, Clinergize etc) including TDS communication of document event date, document submission, quality check/resolution and set up & maintenance of paper TMF documentation/filing and arrangement of long-term archiving process if required
Coordinate clinical trial related document translation process
Support trial related documents verification
Support trial document creation & filing process e.g., local clinical trial protocol amendment, local signature page etc.
Support CTM for the site ISF archival, if locally required to use external archiving vendor
Support RA/EC submission e.g., CTR relevant as applicable
Support updates of clinical trial related information into Clinical Trial Management System (e.g., Veeva Clinical)

What we offer

Supportive work environment
High degree of empowerment and accountability
Work with a diverse set of clients and therapeutic areas
Encouraged to take on new challenges and pursue your interests
Supportive and inclusive environment
Flexible work arrangements
Remote, in-office and hybrid roles
Varied project experience
Career progression

Director Medical Data Review

At Amgen, if you feel like you’re part of something bigger, it’s because you are...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master/ Doctorate/ MD with ~ 18 years of Industrial experience
9+ years of experience in life sciences or a medically related field, including significant experience in medical monitoring and/or clinical data review
Prior people management experience with direct reports
Demonstrated strategic leadership of a clinical data review or medical monitoring function
Experience leading clinical trial process improvement and data quality optimization initiatives
Strong communication and presentation skills (written and oral)
Deep understanding of operational aspects of clinical data review
Advanced proficiency with clinical data analysis tools (e.g., Spotfire or equivalent)

Job Responsibility

Define and execute the enterprise-wide vision, strategy, and multi-year roadmap for Medical Data Review (MDR), including operating model, technology enablement, workforce capabilities, and organizational transformation
Lead enterprise transformation initiatives that advance risk-based and technology-enabled clinical oversight, including AI-assisted review, automation, RBQM integration, integrated data review, and predictive risk management
Establish and govern enterprise standards, KPIs, quality benchmarks, and risk thresholds to ensure consistent, high-quality medical data review across the clinical development portfolio
Partner with senior leaders across Therapeutic Areas, Clinical Operations, Data Management, Safety, and Digital functions to drive strategic alignment and resolve enterprise-level trade-offs involving quality, timelines, cost, and risk
Establish and lead governance frameworks that provide oversight of clinical data review strategy, quality performance, risk management, and continuous improvement across the organization
Provide strategic leadership for the global MDR organization, including organizational design, resource planning, capability development, and scalable operating models that support diverse clinical programs
Drive operational excellence and trial delivery predictability through proactive performance management, data-driven decision-making, and standardized yet flexible review frameworks
Evaluate emerging industry trends and translate innovations into practical enterprise capabilities that improve quality, efficiency, and risk management
Own the enterprise inspection readiness strategy for clinical data quality, ensuring robust review traceability, regulatory compliance, proactive risk mitigation, and executive-level issue escalation
Champion innovation through the adoption and scaling of advanced analytics, AI/ML-enabled capabilities, predictive risk modeling, and integrated review technologies that transform insights into business outcomes

Fulltime

Director, Research Services, Oncology

As a Director, Research Services at ICON, you will be responsible for working wi...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Degree in a scientific/life sciences field
Pharm.D. or Ph.D. preferred
Minimum of 8 years of experience in oncology research or related field
Demonstrated experience leading clinical development programs in oncology (preferably late-stage)
Experience with global regulatory interactions and submissions (FDA, EMA, or other agencies)
Strong understanding of oncology clinical endpoints, trial design, and statistical considerations
Proven ability to work effectively in a cross-functional matrix environment and influence without direct authority
Track record of scientific publications and/or conference presentations
Excellent written and oral communication skills
Strong analytical and scientific writing skills

Job Responsibility

Development of protocols for clinical studies
Preparation of clinical development plans
Drafting of clinical scientific documents such as IND, IND amendments, Investigator’s Brochures, Annual Reports and other FDA submissions
Monitor, perform data review, and summarize safety and efficacy data in ongoing studies
Assist with study design for exploratory development
Lead the clinical matrix teams for assigned compounds
Represent exploratory development on project teams
Develop relationships with appropriate consultants
Write abstracts and present data at scientific meetings, both internally and externally
Serve as liaison to project teams, CROs and others

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

Director, Pharmacovigilance

This is a unique opportunity to join a growing Pharmacovigilance team. This PV e...

Location

United States , Cambridge

Salary:

210000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent degree with pharmaceutical industry background and proven competence in PV
Healthcare professional degree preferred (Nurse Practitioner, Physician Assistant, RN/BSN, Pharm D, MD, or equivalent)
10+ years’ pharmaceutical industry experience, including a minimum of 5 years’ experience in PV
Knowledge of MedDRA dictionary, clinical trial methodology, medical terminology, and general principles of clinical assessment of AEs
Demonstrated knowledge of global PV regulatory environment with working knowledge of international regulations including but not limited to FDA, EU, GVP, ICH guidelines and regulations pertaining to clinical development and post-marketing safety environments
Working knowledge of industry standard safety databases (ARGUS and ARISg) and other electronic data capture systems
Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data
Experience in the preparation and authoring of pre- and post- aggregate safety reports
Thorough understanding of the drug development process and context applicable to safety surveillance activities
Ability to execute and follow-through to completion and documentation

Job Responsibility

Oversight of day-to-day safety monitoring activities and safety operations of clinical trials for assigned product(s)
Provide PV subject matter expertise on clinical development teams and other cross-functional forums throughout the company
Ensure that safety reports for assigned products are triaged, processed and submitted/distributed as required per global requirements and applicable SOPs
Perform individual case safety report assessments for clinical trial safety reports, including review of Analysis of Similar Events, as applicable
Contribute to the development and review of clinical, regulatory, and scientific documents including clinical study protocols, informed consent forms, study plans, clinical study reports, manuscripts/journal articles, scientific abstracts/posters, case report forms, statistical analysis plans, and/or other documents as needed
Facilitate internal cross-functional Safety Management Committee and/or other safety governance/review meetings
including coordinating materials, data outputs and presentation, agenda and minutes
Work closely with the Medical/Safety Lead to support signal detection activities, which may include: preparing signal assessment, tracking, and validation documents
leading cross functional teams to assess safety signals
preparing action and communication plans to mitigate/manage product risks

Fulltime

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Global Clinical Trial Assistant

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