Clinical Project Associate Job at canfield scientific

Clinical Research Associate II/Sr. Clinical Research Associate - 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

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
Must be fluent in English and in the native language(s) of the country they will work in
Ability to travel 60-80%
Valid driver’s license and passport required
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Job Responsibility

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's 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
Serve as the primary point of contact for assigned investigator sites
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with Site Care Partner 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
Attend investigator meeting when required (virtual or F2F)
Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
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

What we offer

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

Clinical Trial Operations Associate

Beacon Biosignals is on a mission to revolutionize precision medicine for the br...

Location

United States , Boston

Salary:

Not provided

Beacon Biosignals

Expiration Date

Until further notice

Requirements

Experience in clinical project management or clinical operations roles
Strong organizational and project management skills, with the ability to manage multiple responsibilities effectively
Excellent written and verbal communication skills in English
A proactive mindset with the ability to identify priorities and anticipate challenges
Meticulous attention to detail, ensuring accuracy in data collection and reporting
Familiarity with GCP, ICH guidelines, and clinical research regulatory requirements
A desire to learn more about analytics, statistics, machine learning, and clinical trials

Job Responsibility

Collaborate with project teams to support study startup activities
Act as the primary point of contact for clinical sites, ensuring smooth operations and clear communication
Provide training to research sites on the use of Beacon’s devices and study protocols, ensuring proper device usage and data collection
Monitor project progress, ensuring adherence to timelines, protocols, and quality standards
Maintain compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory standards
Address operational issues promptly, escalating through tools like Zendesk and Asana for resolution
Provide actionable feedback from research sites to inform improvements in devices and workflows

What we offer

equity
PTO

Senior Clinical Research Associate

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

Location

Taiwan , Taipei

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree in a relevant field such as life sciences, nursing, or medicine
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license

Job Responsibility

Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations

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

Associate Vice President, Clinical Data Management

The Associate Vice President, Clinical Data Management is a member of the Global...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s or master’s degree with 25+ years of data management experience
10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment
Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM)
Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen’s global clinical development efforts
Expertise in AI/ML-driven data management solutions, automation, and advanced analytics
Understanding of clinical data standards (CDISC, SDTM, ADaM)
Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions
Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management
Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams

Job Responsibility

Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals
Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases
Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows
Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums
Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance
Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization
Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues
Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions
Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics
Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data

Project Manager Storage & Distribution

Manages assigned clinical customer projects to ensure that project goals and obj...

Location

United Kingdom , Bridgend

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Preferably qualified in a scientific discipline (degree, HNC or equivalent)
Experience in a client facing role, preferably in the clinical supply field and a contract environment
An excellent understanding of Quality Standards including GMP, GCP and GDP. Familiar with concepts of risk management
Experience in managing projects, change and growth
Clear and concise presenter to internal/external customers
Proficient in the use of JD Edwards ERP system
Excellent written and verbal communication
structures communication in a logical way. Matches influencing style to the person and/or situation and secures positive outcomes through negotiation

Job Responsibility

Manages assigned clinical customer projects to ensure that project goals and objectives are accomplished within the prescribed time frame, budget, and in accordance with customer expectations
Fill role of Lead Project Manager for global clinical studies where required
Diligently manages significant matters pertaining to assigned projects
Responsible for all activities associated with a Clinical Distribution project
Primary customer contact for distribution activities, including business, relationship and customer expectation management matters
Prepare the Logistics Management Document as it pertains to the customer’s specific study
Assist in the development of detailed pack construction to ensure that the packaging is designed in a way that allows for efficient storage and distribution
Coordinates project activity by leading the Distribution Project Team and through working closely with the Clinical Project Management team as well as internal and external customers
Interacts with customers, vendors, and internal PCI colleagues to deliver service excellence
Coordinates distribution activities from order receipt to shipment acknowledgement as per Logistics Management Document

Fulltime

New