Senior Clinical Trial Specialist Job at iconplc (Blue Bell)

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 Contract Specialist, Clinical Research Agreement

The Clinical Research Agreements team manages the contract negotiation of indust...

Location

United States , Boston

Salary:

69888.00 - 111831.20 USD / Year

Boston Children's Hospital

Expiration Date

Until further notice

Requirements

Bachelor's degree
2+ years of relevant experience
ability to effectively negotiate with peer level department heads and/or with external agencies/facilities on issues and programs that impact department as well as several other large departments/divisions

Job Responsibility

Drafts and negotiates written clinical research related agreements with corporate sponsors and other outside entities
Conducts negotiation of complex clinical research agreements and attends to relevant terms
Assures timely completion of negotiation proceedings
Acquires and maintains knowledge of Hospital’s policies and procedures applicable to clinical sponsored research
Develops functional understanding of the business needs of the hospital administrative and research staff
Evaluates and makes recommendations for systems, policies and procedures
Advises faculty on BCH and sponsor requirements for clinical corporate sponsored research agreements
Responsible for overseeing pre award administration of clinical research agreements
Supports strategies for marketing the hospital’s research capabilities and clinical trial resources to industry
Advises on quality improvement efforts

What we offer

flexible schedules
affordable health, vision and dental insurance
child care and student loan subsidies
generous levels of time off
403(b) Retirement Savings plan
Pension
Tuition and certain License and Certification Reimbursement
cell phone plan discounts
discounted rates on T-passes

Fulltime

Senior Clinical Research Specialist

The Senior Clinical Research Specialist will conduct clinical research throughou...

Location

United States , Burnsville

Salary:

105000.00 - 147000.00 USD / Year

Imricor Medical Systems

Expiration Date

Until further notice

Requirements

BA/BS education in relevant discipline required
5 years clinical experience in the medical device industry strongly preferred
Highly skilled and proficient at clinical trial management/execution
Conduct complex work under minimal supervision and with wide latitude for independent judgment
Experience with Microsoft Office: Word, Excel, PowerPoint

Job Responsibility

Prepares and authors clinical documents such as: protocols, patient informed consents, case report forms, clinical trial agreements, and/or investigator brochures/report of prior investigations as needed
Develops and executes site training on protocol and data management requirements
Communicates with Regulatory agencies (FDA, European Competent Authorities, etc) to develop and implement clinical trials to support our products
Develops monitoring plans and monitors or oversees monitoring of clinical sites
Oversees adverse event review committees and/or data review committees as necessary (develop and execute charters)
Identifies and communicates with CROs as necessary based on study needs
Oversee and resolve operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations
Prepares and maintains clinical trial budgets for specific projects
Authors clinical reports (interim and final) for both regulatory bodies and publications as necessary
Communicates cross functionally with multiple stakeholders in the company – including regulatory, marketing, product development

What we offer

Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits

Fulltime

Senior Clinical Research Associate/Clinical Research Associate II - Oncology

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

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization
Preferred therapeutic experience in Oncology
Global clinical trial experience preferred
Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Must be fluent in English and in the native language(s) of the country they will work in
Travel (60-80%) within area is required
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

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor 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

What we offer

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

Fulltime

Senior Clinical Research Associate

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

Location

Argentina

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 3 years relevant experience in clinical research site monitoring (preferably 2 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

Patient-focused in everything we do
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

Senior Pharmacovigilance Specialist

Location

Switzerland , Baar

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Strong ability to interpret, analyze, and present scientific and medical data clearly in both verbal and written formats
Expertise in pharmacovigilance processes, including safety signal management, aggregate report authoring, and regulatory compliance
Solid understanding of global clinical trial and post-marketing safety regulations
Proficiency in data processing tools such as Excel, PowerPoint, and Word, as well as familiarity with safety database systems
Demonstrated leadership and collaboration skills within cross-functional teams
Strong organizational abilities, with the capacity to prioritize tasks independently
Educational background in biological or natural sciences, health disciplines, or an advanced degree (e.g., PhD, MPH, NP, PharmD)
Experience in pharmacovigilance, particularly in aggregate safety reporting and signal management

Job Responsibility

Lead safety signal management processes, including detection, tracking, documentation, and evaluation of safety data
Synthesize data from multiple sources and author signal evaluation reports
Manage literature reviews to identify relevant safety information
Oversee the preparation, review, and finalization of aggregate safety reports, such as PSURs, DSURs, Risk Management Plans (RMPs), and other related documents
Respond to safety-related inquiries from regulatory authorities
Collaborate with cross-functional teams, including Safety, Clinical Development, Medical Affairs, and Regulatory, to support investigational programs and clinical trial activities
Provide clinical judgment and analysis for case information and safety data
Facilitate Safety Signaling Team meetings and ensure alignment on safety strategies

Fulltime

Senior Pharmacovigilance Specialist

The Local Pharmacovigilance Specialist is responsible for the execution of tasks...

Location

Ukraine , Kyiv

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Professional education or University degree in Life Science preferred but not essential
Basic understanding/knowledge in the field of pharmacovigilance and medical information
Ability to prioritize and manage own time and tasks
Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level
Good communication skills (written and verbally)
capability to point out issues and provide potential options for solution in the area of expertise
English business fluent

Job Responsibility

Data entry and quality control of Individual Case Safety Reports (ICSR) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and the literature
reporting of ICSRs to the competent authorities
Support in the generation, processing, documenting, and tracking of follow-up requests
Screening and documentation of scientific literature regarding safety relevant publications
Assist in the creation of periodic reports PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports), risk management plans and signal detection reports
Interact with customers as needed (e.g. meetings, client visits, day to day case processing, etc.)
PSMF maintenance
Contribute to/review QA documents such as Working Instructions, SOPs, Working Procedures, templates, project metafiles, etc. for pharmacovigilance projects
Prepare for and participate in internal and external audits/inspections
Training new colleagues in relevant tasks

Fulltime

Senior Project Specialist

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

Location

Belgium , Rixensart

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Degree qualified, preferably in a science subject
Expertise in science background e.g. labs, to ensure proper project planning, prevent and mitigate risks and meet timelines is preferred
Clear understanding of project management and applicable tools
Good stakeholder management skills and a problem-solving mindset
Result-driven with a sense of urgency
Requires the ability to negotiate and manage competing priorities
Excellent interpersonal, verbal and written communication skills
Attention to detail and understanding how quality of own work impacts others and the business outcomes
Flexible attitude with respect to work assignments and an openness to new learning and role modelling adoption to change
Ability to manage multiple and varied tasks with enthusiasm and to teach others in these tasks

Job Responsibility

Project Management Plans initial set up and maintenance with Project Leader and Functional Lead input, communication of plans to the wider project team and support with execution of the plans
Maintenance of selected information in the integrated project management system and leading work with other functions on compliance of data in the project systems
Project reports, compliance and other metrics for project operational review, client and internal reporting and project oversight, including analysis of data
initiation and follow up on required actions in alignment with PL and FLs
Review of selected financial areas and follow up with stakeholders on required corrections. Provide reconciliations to PL, as agreed
Cooperation with Project Leader and Functional Leads on different action plans and follow up with the project team until action completion
Oversight of project team list, project system accesses and respective reviews
development of respective processes and roll out to the project team as needed
Study reporting and analysis with subsequent highlighting issues for project team
Maintaining systems and tools according to applicable SOPs

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
Tremendous long-term job security and prospects
Exciting professional challenges in inspiring studies, but with time for your outside life
Open and friendly work environment
Opportunities to develop long-term careers
Opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments

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Senior Clinical Trial Specialist

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