Clinical Trials Assistant (CTA) Job at EnglishJobs.se (Stockholm)

Clinical Trial Associate 3 (CTA 3)

As a SMA II at ICON, you will support the management and monitor of clinical tri...

Location

Mexico , Mexico City

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field such as life sciences, healthcare administration, or clinical research
Experience in clinical research, site management, or monitoring, with a solid understanding of clinical trial processes and GCP guidelines
Strong organizational and project management skills, with the ability to handle multiple priorities and deadlines
Excellent analytical skills and attention to detail, with a focus on maintaining high-quality standards
Exceptional communication and interpersonal skills, with the ability to build and maintain effective relationships with site personnel and cross-functional teams
Willingness to travel as required (approximately 25%)

Job Responsibility

Coordinating monitoring activities at clinical trial sites, ensuring adherence to study protocols and timely resolution of site-related issues
Assisting in the preparation and review of regulatory documents, ensuring all site activities are compliant with GCP and applicable regulations
Collaborating with cross-functional teams to facilitate effective communication and support for trial sites throughout the study lifecycle
Tracking site performance metrics, analyzing data, and providing reports to enhance site management efficiency
Participating in training initiatives and mentoring junior staff to support their development in clinical trial management

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

Senior Analyst, Site Contracts & Budgets

Parexel FSP is hiring a Senior Analyst, Site Contracts & Budgets in Argentina. T...

Location

Argentina

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Three to five years or experience in the pharmaceutical or biotechnology industry in clinical site contracts and/or outsourcing management
Proficient with Excel and PowerPoint
Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization
Willingness to learn international clinical pharmaceutical standards, ICH/GCP guidelines and regulatory compliance issues
Strong interest in learning more about contracts and budgeting in support of Sponsor clinical trials
Working knowledge of clinical trial functions, including clinical operations, regulatory and drug safety
Ability to prioritize and manage multiple tasks simultaneously
Some limited travel may be required

Job Responsibility

Negotiate and maintain Clinical Trials Agreements (CTA), site budgets, Confidential Disclosure Agreements, Consultant Agreements, and other applicable contracts
As required, oversee CRO or Functional Service Provider in the development of clinical site budgets and partner with clinical operations to ensure budgets are in line with study protocols
Ensures compliance of contracts with Fair Market Value (FMV) principles and guidelines
Track contract progress, complete required follow-ups and coordinate the timely completion of clinical sites contracts
Oversee CRO and Functional Service Provider activities in regards to site CDAs
Collaborate and coordinate with cross-functional teams
R&D, Legal, Compliance, Procurement and Finance in executing contracts
Develop, maintain, and analyze tools and systems (spreadsheets, Smartsheet, databases, etc.) to manage contract lifecycle from initiation through contract execution, and build internal metadata to support accurate reporting
Provide guidance and direction to new clinical operations and/or outsourcing team members and R&D teams on site contracts & budgets processes
Provide accurate progress updates to Clinical Operations teams on all outstanding contracts and budgets

What we offer

Benefits vary by country, but Parexel is passionate about our team’s overall wellness
flexible working options

Fulltime

Senior CTA

As a Senior CTA at ICON, you will support the management and monitor of clinical...

Location

United States

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field such as life sciences, healthcare administration, or clinical research
Experience in clinical research, site management, or monitoring, with a solid understanding of clinical trial processes and GCP guidelines
Strong organizational and project management skills, with the ability to handle multiple priorities and deadlines
Excellent analytical skills and attention to detail, with a focus on maintaining high-quality standards
Exceptional communication and interpersonal skills, with the ability to build and maintain effective relationships with site personnel and cross-functional teams

Job Responsibility

Coordinating monitoring activities at clinical trial sites, ensuring adherence to study protocols and timely resolution of site-related issues
Assisting in the preparation and review of regulatory documents, ensuring all site activities are compliant with GCP and applicable regulations
Collaborating with cross-functional teams to facilitate effective communication and support for trial sites throughout the study lifecycle
Tracking site performance metrics, analyzing data, and providing reports to enhance site management efficiency
Participating in training initiatives and mentoring junior staff to support their development in clinical trial management

What we offer

Various annual leave entitlements
A range of health insurance offerings
Competitive retirement planning offerings
Global Employee Assistance Programme
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

Fulltime

Senior CTA

A South San Francisco based pharmaceutical company is looking for a Contract Sen...

Location

United States , South San Francisco

Salary:

35.00 - 55.00 USD / Hour

Solomon Page

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree in a relevant scientific discipline
Minimum 2 years of pharma or biotech industry experience within clinical trials
eTMF experience
Applicants must be currently residing in South San Francisco

Job Responsibility

Provide key support to the clinical study team to support the planning, implementation, and completion of in house and outsourced studies
Work with investigative sites and vendors to provide support
Review and process clinical study related documents including Clinical Visit summaries, protocols, FDA 1572s, lab certifications, IRB approvals, and more
Responsible for eTMF
Maintain and update Visit Reports, Regulatory Documents, site and team contact lists, vendor lists, and more
Prepare agendas and take comprehensive minutes for meetings
Study level tracking (including monitor visit tracking, sample tracking, study related supplies)
Help prepare materials for investigator meetings, monitor workshops, and study manuals
Ensure completed documents are provided to Regulatory Affairs group
Review clinical data in the database, data listings, and reports

What we offer

Medical
Dental
Vision
401(k)
Telehealth services
ESOP
Commuter benefits

Fulltime

Senior CTA

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

Location

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field.
Prior experience or strong interest in clinical research.
Knowledge of clinical trial processes, regulations, and guidelines.
Experience working in a high-volume environment while maintaining both organization and the ability to multitask
Excellent time and priority management, ability to work efficiently under pressure
Independently managed high quality support and coordination of tasks under own responsibility
Reliable, conscientious and confidential
Motivated, shows initiative, is proactive and able to work independently as well as in a team
Worked in an international/ multicultural matrix environment
Excellent oral and written communication in English as well as administrative and coordination skills

Job Responsibility

Meeting coordination & assistance (including Meeting Minutes and Action& Decision Log)
Invoice processing & budget tracking
Create and maintain Trial Team & Vendor List
Perform CTMS data entry & QC
Coordinate Trial Oversight Plan Reconciliation
Oversight for Translational vendors
Support Data & Safety Monitoring Committee activities
Contribute to activities for Inspection Readiness and Inspection preparation
Create & manage System Access Tracker
Assist for internal Quality issues in internal Quality Management System

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.

Rio execution hub manager

At Pfizer, we are committed to bringing medicines to the world at a faster pace ...

Location

Philippines , Makati City

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience
Demonstrated experience in regulatory affairs, research and development, or quality assurance/compliance
Experience working directly with regulatory agencies
Strong knowledge of the drug development process, regulatory affairs, CTA, and submissions management
Sound knowledge of applicable portions of agency guidance documents and regulations
Ability to exercise good judgment within company policy and health authority regulations with good negotiation skills
Excellent written and interpersonal communication skills

Job Responsibility

Assist in the preparation, publication, tracking, and quality control of regulatory submissions, ensuring compliance with document management standards
Coordinate activities related to enterprise-wide regulatory management systems and provide guidance on moderately complex projects
Apply skills and discipline knowledge to contribute to departmental work, making decisions to resolve moderately complex problems and developing new options
Work independently on assignments, seeking directional review for unusual or complex problems, and review the work of colleagues in a mentor role
Guide operational teams in managing projects, preparing resource forecasts, and identifying areas for improvement in products, processes, or services
Act as a point person for regulatory agency interactions, including preparation of briefing packages and strategy for meetings, inspections, and responses to agency letters
Understand and challenge scientific arguments, identify regulatory scientific data needs, and solve regulatory issues to influence the development of new global products and improvements to existing products
Manage registrations of existing customer products in compliance with applicable regulations and support global team efforts to ensure high-quality, compliant submissions
Provide daily regulatory support to Global Product Development teams and lead the logistics involved with regulatory Clinical Trial Application (CTA) submissions
Manage the preparation of registration packages, responses to deficiency letters, and suggest system improvements to reduce cycle time and increase efficiency

Fulltime

Senior Clinical Associate

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

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

At least Bachelor degree
At least 2 years of experience as CTA (working for Pharmaceutical or CRO company)
Planning and organizational skills
Advanced communication skills

Job Responsibility

Adhere to applicable SOPs WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
Comply with relevant training requirements
Assist in trial specific document management, including finalization, distribution, and document revision management and archiving, with a strong focus on inspection readiness
Assist in IP and ancillary supply management, including ordering, distribution, and tracking
Ensure the current trial status and tracking of trial related information is available at all times in the appropriate Clinical Trial Management System(s) (CTMS) and/or tracking tools
Ensure trial specific data are up-to-date, complete, and accurate during all phases of the trial in collaboration with CRO, Local Trial Managers and Site Managers
Ensure trial delivery according to the agreed upon timelines/milestones by conducting supportive trial coordination activities and tracking of trial timelines and deliverables
Run data & metric reports in support of trial deliverables
Responsible for review/management of Trial Master File (TMF) for completeness and timely provision
Maintain key trial specific information, including trial contact list

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 maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Clinical Trial Manager

We are seeking a Clinical Trial Manger (CTM) to join our growing Clinical Operat...

Location

United States

Salary:

145000.00 - 160000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life science or equivalent
Minimum of 5 years of clinical trial management experience in conducting international clinical trials in a Sponsor Pharma/Biotech organization
Biotech experience strongly preferred
Prior phase II and III experience required
A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
Proven proficiency in overseeing complex studies being managed in house and by a CRO
Demonstrated ability to lead teams and work in a fast-paced, cross functional environment, and able to think critically and creatively
Experience selecting and managing clinical vendors to support study activities
Enjoys building relationships with KOLs and site personnel
Demonstrated ability to build and deliver on patient enrolment strategies

Job Responsibility

Oversee study scope, quality, timelines, and budget with the internal functional leads, CRO, and vendors to ensure overall project objectives are met
Initiate and build strong relationships with key opinion leaders and clinical site staff
Partner with the CRO to ensure robust patient enrolment strategies are developed and effectively implemented, on time and within budget for assigned regions
Partner with the CRO to ensure robust ongoing data monitoring strategies are developed and effectively implemented to ensure delivery of high-quality data
Proactively identify and manage study related risks
Develop and manage clinical trial documents, including but not limited to protocols, Case Report Forms (CRFs), and consents
Review and manage study related plans and processes including Investigator agreements (CTA), site budget review, CRFs, CRF guidelines, Statistical Analysis Plans, Pharmacokinetic Analysis Plans, Monitoring plan, Data Management Plan, and Safety Monitoring Plan
Collaborate with Regulatory/CRO team members to assist with completion/review of regulatory submissions
Review CRO and vendor contracts/work orders and specifications to align with study objectives
Review specifications for systems build and participate in User Acceptance Testing (UAT) (eg, IRT, eCOA, EDC)

What we offer

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

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Clinical Trials Assistant (CTA)

Job Description

Job Responsibility

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