Senior Clinical Trial Specialist Job at iconplc (Blue Bell)

Senior Study Specialist, Global Study Operations

The Sr. Study Specialist (SS) significantly contributes to or leads tasks relate...

Location

United Kingdom , London

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

BA/BS or higher in nursing, life or health sciences is preferred
Industry or relevant experience in lieu of education is considered
Experience in a biotechnology or pharmaceutical company
Experience in oversight of external vendors including SOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging etc.)
Proficient knowledge and experience in Agility and Proactivity, Leadership, Communication and Collaboration, Study Management and Execution, Compliance and Quality, Drug Development and Study Design, Product and Therapeutic Area Knowledge

Job Responsibility

Develop study specific documentation, as delegated by the Study Manager
Contribute to the oversight of country and site feasibility assessment and site selection
Oversight of CRO for IRB/EC related submission/approval activities
Oversight of essential documents for study life-cycle management
Develop/Oversee site and investigator training materials
Present at investigator meetings as assigned
Ensure accurate and timely study entry and updates to ClinicalTrials.gov
Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
Process documents for signature in DocuSign
Oversight of Clinical Trial Insurance

Transparency Specialist document anonymisation

You will lead document anonymisation activities that support ethical and transpa...

Location

India , Bengaluru

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Master’s degree in life sciences, pharmacy, clinical research, or a related field
At least 6 - 9 years’ experience in document anonymisation, clinical trial transparency, or related regulatory work
Experience in Pharmaceutical company environment and specifically in matrix organization
Experience in managing clinical trial (study, data, or system/technology) activities
Good understanding of clinical trial lifecycle, clinical trial metadata, clinical trial data, clinical documents

Job Responsibility

Lead document anonymisation activities that support ethical and transparent sharing of clinical research data
Work closely with cross-functional teams and external partners to prepare, anonymise, review and deliver clinical documents on time
Work closely with senior clinical data transparency leadership to align processes in line with regulations
Serve as a subject matter expert on regulatory requirements for document anonymization
Manage business relationships with external vendors to ensure quality, on time delivery
Manage daily operations of anonymizing clinical documents including regulatory requirements like EMA Policy 0070 and Health Canada PRCI
Take overall accountability for the document anonymization capability, driving development, competence, and strategy
Maintain strong relationships with internal business partners and act as a key contact
Create and lead a community of practice to improve cross‑communication between central functions, medical policy, and statistics/programming groups
Contribute to industry and regulatory standards for data re‑use and anonymization

What we offer

Clear career development
Meaningful impact on public trust in research
Alignment with GSK’s mission

Fulltime

New

Senior Clinical Trial Specialist

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

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree or certification in a relevant field such as life sciences, healthcare, or clinical research
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 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

Senior Clinical Research Associate II - FSP

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

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

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 to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

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

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...

Location

United States; Canada , Remote; Alberta

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Good knowledge of drug safety and the drug development process
Good knowledge/understanding of medical terminology
Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice
3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required
US Board Certification/board eligibility or regional equivalent for Canada
Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
Completion of at least basic training in clinical medicine (residency, internship etc.)
Demonstrated success in technical proficiency and scientific creativity
Good presentation and verbal/written communication skills

Job Responsibility

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs
as applicable) and liaising with the client, as require
Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
Review appropriateness of medical content in narrative for medical coherence
Assessing seriousness, listedness / expectedness of reported events
Providing medical inputs to case processing team
Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative

What we offer

Flexible approach to work that meets your personal needs
Work from home
Benefits vary by country
Investment in your professional and personal development

Temporary Life Science Administrator

Our client is a well-established pharmaceutical organisation who enhance and imp...

Location

United Kingdom , London

Salary:

14.20 GBP / Hour

Office Angels

Expiration Date

Until further notice

Requirements

Life Science background and degree
Strong knowledge of Microsoft Excel

Job Responsibility

Manage the agency database(s) and check consistency between public registers
Inputting applications on the Agency databases and supporting the application specialists with allocation of both clinical trials applications and monitoring of timelines
Assists with generating performance measures for UK trial, and trial registration and summary results posting
Work with the application specialists in data analysis, presentation of Unit metrics for reports and enquiries as required
Assist the Business Support Manager and Operations Lead in implementing Internal Quality Measures and Scientific Advice Meetings
Assist the Senior Safety Manager with finance aspects of new fees from clinical trial annual safety reports

What we offer

Weekly pay every Friday
Easy timesheet accessibility with mobile support
Up to 29 days annual leave
Perks at work and discount schemes for all major retailers and over 150 high street stores
Access to free eye-care vouchers and discounts towards glasses for VDU purposes
Access to well-being platforms
FREE access to online LinkedIn Learning courses
Temp of the Month awards
Dedicated consultant to support your job search and offer expert interview tips

Fulltime

Senior Clinical Research Specialist

Are you a clinical research professional looking to make a significant impact in...

Location

Belgium , Zaventem

Salary:

Not provided

Randstad

Expiration Date

April 25, 2026

Requirements

Minimum of a Bachelor’s degree in Life Sciences, Nursing, or a related Biological science
BS with 4+ years, MS with 3+ years, or a PhD with 2+ years of relevant clinical research experience
A strong background in the pharmaceutical or MedTech industry is required
Specific experience in Cardiology or Electrophysiology is highly preferred
Deep knowledge of ICH-GCP guidelines and global clinical trial regulations
Fluent in English (written and oral)
proficiency in other European languages is a distinct advantage
You are proactive, assertive, able to prioritize effectively, and thrive in a collaborative team environment
Willingness to travel approximately 20-25% for site visits and international collaboration

Job Responsibility

Manage the set-up, conduct, and closure of clinical trials in accordance with ICH-GCP, MDR, and company SOPs
Serve as the primary contact for clinical trial sites and foster strong relationships with investigators, IRBs/ECs, and external vendors
Contribute to the creation of essential study documents, including protocols, informed consents, CRFs, and monitoring plans
Oversight of Clinical Research Associates (CRAs) and performing site visits (qualification, initiation, monitoring) as required by study needs
Perform clinical data reviews for statistical analysis and potentially act as a Clinical Safety Coordinator to manage adverse event reporting and safety management plans
Lead small study teams to deliver milestones on time and within budget, while mentoring junior team members

Life Science Administrator

Temporary Life Science Administrator role for a pharmaceutical organization work...

Location

United Kingdom , London

Salary:

14.20 GBP / Hour

Office Angels

Expiration Date

Until further notice

Requirements

Life Science background
Relevant Life Science degree
Strong knowledge of Microsoft Excel

Job Responsibility

Manage the agency database(s) and check consistency between public registers
Inputting applications on the Agency databases and supporting the application specialists with allocation of both clinical trials applications and monitoring of timelines
Assists with generating performance measures for UK trial, and trial registration and summary results posting
Work with the application specialists in data analysis, presentation of Unit metrics for reports and enquiries as required
Assist the Business Support Manager and Operations Lead in implementing Internal Quality Measures and Scientific Advice Meetings
Assist the Senior Safety Manager with finance aspects of new fees from clinical trial annual safety reports

What we offer

Weekly pay every Friday
Easy timesheet accessibility with mobile support
Up to 29 days annual leave
Perks at work and discount schemes for all major retailers and over 150 high street stores
Access to free eye-care vouchers and discounts towards glasses for VDU purposes
Access to well-being platforms
FREE access to online LinkedIn Learning courses
Temp of the Month awards
Dedicated consultant to support your job search and offer expert interview tips

Fulltime

Senior Clinical Trial Specialist

iconplc

Location:
United States , Blue Bell

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 03, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Senior Clinical Trial Specialist

Senior Study Specialist, Global Study Operations