Study Start Up CRA Job at iconplc (Buenos Aires)

CRA, Study Start-up and Maintenance

Specializing in oncology, Kapadi excels at navigating the early stages of drug d...

Location

Poland , Cała Polska

Salary:

Not provided

GRUPA NEUCA

Expiration Date

Until further notice

Requirements

proven 5+ years of experience in study start-up processes in clinical research
a medical-related university degree
working knowledge of ICH-GCP and local regulatory guidelines
strong communication, organizational, and multitasking skills

Job Responsibility

site and project coordination: act as the main point of contact for clinical sites throughout the study lifecycle, providing support for site initiation, compliance, and regulatory documentation
documentation & tracking: maintain and update project documentation, tracking activities, site status, and action items according to SOPs
regulatory maintenance: oversee regulatory updates, including protocol amendments, safety reports, and IRB/IEC submissions, ensuring all documentation is current and compliant
training & compliance: complete required training and keep up-to-date with ICH-GCP guidelines and relevant local regulations
budget and contract: oversight and liaison between site and sponsor with budget and contracts

What we offer

remote work opportunities
professional development in a well‑established company with a strong market position
employment in a company awarded the Top Employer 2026 certificate – we create a work environment based on trust, collaboration, and diversity
a comprehensive benefits package in the form of a cafeteria system – you decide which benefits best suit your needs
Private medical care
Free legal advice
Social benefits
Employee referral program
Day off on birthday
Life insurance

Associate Director, Clinical Operations

We are seeking an Associate Director, Clinical Operations who will be accountabl...

Location

United States

Salary:

180000.00 - 195000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

BA/BS in life sciences or equivalent
8+ years of clinical research experience, including at least 3 years leading global projects from inception to completion
2+ years’ experience in Biotech industry strongly preferred
Significant knowledge of pharmaceutical industry, drug development and regulatory processes
Experience developing all Clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, trial budgets and program-level budgets
Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety
Strong communication skills with ability to present to a variety of stakeholders and tailor message accordingly
Strong project management skills with ability to collaborate effectively cross-functionally and hold team and CRO members accountable to tight timelines and budgets
High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines
Work comfortably in a fast-paced, dynamic work environment and embrace change

Job Responsibility

Accountable for overall management of multiple clinical trials
Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols
Works cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion
Leads the Clinical Study Team (CST) and may participate in other cross functional program team meetings
Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
Responsible for preparing and/or presenting to executive management as delegated
Develops, reviews and/or consults on clinical trial documents, such as study specific plans, informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates
May be responsible for participating and presenting at Investigator Meetings, SIVs and other program meetings
Responsible for study level clinical operations budget forecasting, accrual management and quarterly review ensuring tight control between study forecasts and actuals
In conjunction with key stakeholders, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc

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

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

Senior In-House Clinical Research Associate

The Senior In-House Clinical Research Associate (CRA) supports the planning, exe...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

A bachelor's or master's degree in a relevant field, such as life sciences, nursing, or pharmacy
At least 2-3 years of experience in clinical research, preferably in a CRA or related role
Experience with all aspects of trial and site startup and vendor selection and management, study management, and monitoring
Strong knowledge of clinical trial conduct, GCP, FDA regulations, and ICH guidelines
Excellent written and verbal communication skills to effectively communicate with study sites, investigators, and internal study team members
Strong organizational skills to manage multiple tasks and priorities simultaneously
Strong attention to detail to ensure accurate and complete data collection and documentation
Proficiency in Microsoft Office applications and experience working with electronic data capture systems (EDC)
Ability to build positive relationships with study sites and investigators
Flexibility to adapt to changing project needs and timelines

Job Responsibility

Provide monitoring oversight by reviewing monitoring reports and escalate any trends with respect to data quality or study conduct to the appropriate CTM, Clinical Operations
Perform clinical research site activities, such as onsite or remote co-monitoring, training, motivational, and sponsor oversight visits, as needed
Support the oversight of activities of CRO and study vendors to ensure compliance with the study protocol and on-time achievement of overall clinical objectives and deliverables
Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, study plans and CRFs. Contribute to study start-up activities including site selection
Support the Clinical Operations team and cross-functional representatives as required in relationship management tasks (e.g., study logistics, patient enrollment, safety, data management, etc.) to accurately coordinate clinical study activities
Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies
Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of study activities
Identify and resolve study-related issues and deviations
Communicate with study sites and investigators
Provide support to study sites, including training and troubleshooting

What we offer

health and retirement, PTO, and stock option plans

Site Care Partner II

The Site Care Partneris a key Pfizer point of contact for investigative sites th...

Location

Taiwan , Taipei

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 7 years’ experience)
Proficiency in local language preferred. English is required
Work as SCP I experience above 2 years
Demonstrated experience in site management with prior experience as a CRA/ Site monitor
Demonstrated experience in start up activities through to site activation
Demonstrated experience in conduct and close out activities
Demonstrated knowledge of quality and regulatory requirements in applicable countries
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Must demonstrate good computer skills and be able to embrace new technologies
Excellent communication, presentation and interpersonal skills

Job Responsibility

Accountable for site start-up and activation
Deploy GSSO site strategies by qualifying and activating assigned sites
Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide PTA output for site selection
Supports the Feasibility Strategy and Analytics Lead to ensure that high quality feasibility results are delivered
Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable)
Provide country/regional level input to country strategy, feasibility and protocol design in collaboration with relevant Medical Affairs colleagues, and with input from external clinical experts as required
Maintain a knowledge of assigned protocols
Conduct study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation
Ensure all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation. (e.g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF etc.)
Support country specific ICD review and deployment when applicable

Fulltime

Clinical Research Associate

Proclinical is seeking two Clinical Research Associates to join our client on a ...

Location

United Kingdom , City of London

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Experience in Clinical research, preferably within a CRO or pharmaceutical setting
Previous history of independent monitoring experience is required
Background in diabetes or obesity therapeutic areas is beneficial but not essential
Strong organizational and communication skills
Capacity to travel regionally as the business requires
Academic candidates with relevant experience, including monitoring, will also be considered

Job Responsibility

Conduct site visits within the select region
Perform monitoring activities to ensure adherence to compliance standards with study protocols, regulatory requirements, and GCP
Work closely with site staff to ensure proper documentation and data collection
Support study start-up, maintenance, and close-out activities
Maintain effective communication with study teams and stakeholders
Provide updates and reports on site performance and study progress

Fulltime

Clinical Research Associate II

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

Location

India , Bengaluru

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Substantial start up experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
Demonstrate strong problem-solving skills
Able to take initiative and work independently, and to proactively seek guidance when necessary
Excellent presentation skills
Client focused approach to work
Ability to interact professionally within a client organization
Flexible attitude with respect to work assignments and new learning
Ability to prioritize multiple tasks and achieve project timelines
utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise

Job Responsibility

Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase
Build relationships with investigators and site staff
Support on request country specific feasibility and/or site pre-qualification and qualification activities
Manage country and site level TMF issues ensuring documents’ First Time Quality (FTQ) as well as providing direct resolution to reported site problems
Develop strategy to configure, distribute, collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents
Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations, and customize and negotiate any amendments
Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval
Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy
Forecast, develop, manage, and revise plans and strategies for IRB/IEC and MoH / RA submission/approval and Site activation
Update and maintain appropriate Clinical Trial Management System (CTMS) in a timely manner

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

Clinical Trial Oversight Manager

Do more with the knowledge you’re working hard to acquire and the passion you al...

Location

Italy , Milan

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree OR Doctorate degree OR BA/BS/BSc or qualified nurse (RN)
Work experience in life sciences or medically related field, including Biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)
Broad work experience working in life sciences or medically related field, including clinical site management experience, obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience as a CRA, CTA, and/or Clinical/Regional Manager in the biopharmaceutical industry
Experience in a project leadership role
Experience working with or for Functional Service Provider or Contract Research Organizations
Supervisory Experience
Knowledge of or work experience with a biopharmaceutical GRDCA or QC department
Familiarity with advanced concepts of clinical research, extensive knowledge of ICH/GCP regulations and guidelines, strong knowledge of clinical trial operations, and understanding of Functional Service Provider operational model
Computer and system operation skills

Job Responsibility

Perform sponsor oversight activities of SM-FSP, including staff performance (KPIs, report(s) metric analysis/review), to ensure quality and delivery of Amgen clinical trials
Collaborate closely with SM-FSP Line Manager (FSPLM) to ensure appropriate level of their staff oversight is deployed
Support SM-FSP staff onboarding and training
Be a point of escalation for all stakeholders to support resolution of issues on quality, staff turnover and performance concerns
Work with SM-FSP vendor(s) to ensure timely and appropriate planning, resource and capacity management from study start up to close-out
Conduct on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships
Support inspection readiness, local country and site level audits and regulatory inspections when applicable including CAPA resolution
Organize and lead the Functional Management Team (FMT) Meetings and any other country-level project review meetings, if applicable
Be involved in local and global site management and cross functional stakeholder collaboration
Actively participate in role forums including local and global functional and cross-functional initiatives

What we offer

Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

Fulltime

Study Start Up CRA

iconplc

Location:
Argentina , Buenos Aires

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 04, 2026

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Job Description:

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