Site Management Associate II Job at iconplc (Buenos Aires)

Site Management Associate II with French

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

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
Excellent English and French required

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 project related documents in the Investigator Site File and Trial Master File, 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

Site Contract Associate Ii

Parexel are looking for a Site Contract Associate I to join our Site Contracts t...

Location

Serbia; Romania

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Fluent command of German and English (written and oral) is required in addition to the local language
Solid working proficiency of all MS Office Products specifically, Excel, Word, and PowerPoint
Some experience of working on contracts/agreements
Strong negotiation, diplomacy, and excellent organizational skills with demonstrated experience handling multiple projects
Excellent interpersonal, verbal and written communication skills
Strong problem-solving skills
Ability to successfully work in a “virtual” team environment
Must have strong analytical skills with the ability to create or interpret legal language and budgets
Maintain grace under pressure while displaying a high level of professionalism
Align internal and external resources to achieve objectives

Job Responsibility

Draft, review and negotiate all site agreements including but not limited to clinical study agreements, service agreements, team member agreements and other types of related documents like letters, notices, etc.
Provide context to comments received from sites in light of local legal and business framework, common practices, and past negotiation experience for the purpose of further review up the decisioning chain
Apply and scrutinize site contract and related documents and their revisions against negotiation and budget parameters (as applicable)
Ensure final documents comply with applicable laws, regulations, and guidelines, including ICH – GCP
Ensure the best interest of both clients and Parexel are met
Serves as key communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
Manage the contract execution process, including obtaining required signatures and ensuring timely execution of the document by all parties
Follow record maintenance and archival guidelines to ensure they are met
Develop and maintain positive relationships with clinical trial sites
Develop and maintain a thorough understanding of the clinical trial protocol, budget, and timelines to ensure that contract terms align with the overall trial goals and objectives

Fulltime

Clinical Research Associate II (CRA II) - Late Phase

We are seeking a Clinical Research Associate to join ICON Commercialisation & Ou...

Location

Italy , Milan

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree in Life Sciences, Nursing, Pharmacy, or Medicine and Certification for monitoring trials
Experience as a Clinical Research Associate, ideally within late phase / Phase IV / real-world studies (1-2 years min)
Experience across both investigational product (IP) and medical device trials is highly desirable
Strong understanding of ICH-GCP, regulatory requirements, and post-marketing study environments
Proven ability to manage multiple sites and competing priorities
Expertise in site monitoring, data integrity, and risk-based monitoring approaches
Proficiency in clinical systems (e.g., CTMS, EDC)
Willingness to travel across Italy (~6–8 days per month)
Excellent communication, stakeholder management, and influencing skills

Job Responsibility

Site Monitoring & Oversight: Conduct on-site and remote monitoring visits across late phase studies, ensuring compliance with protocols, ICH-GCP, regulatory requirements, and applicable device regulations
Late Phase Study Delivery: Support execution of post-authorisation, observational, and interventional studies, ensuring high-quality data collection and real-world evidence generation
Site Performance & Issue Resolution: Evaluate site performance, identify risks, and implement solutions to ensure studies are delivered on time and to quality standards
Cross-Functional Collaboration: Partner with project teams, medical, data management, and commercial stakeholders to ensure efficient study delivery and reporting
Training & Mentorship: Provide guidance and support to site personnel and junior CRAs, maintaining consistency and best practice, where applicable
Stakeholder Engagement: Build strong relationships with investigators and site staff to drive engagement and successful study execution

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

Clinical Research Associate II / Senior Clinical Research Associate Large Pharma

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

Location

Germany , Frankfurt

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Master or Bachelor's degree in a scientific or healthcare-related field
Minimum of 2 years of experience as a Clinical Research Associate
In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines
Strong organizational and communication skills, with attention to detail
Ability to work independently and collaboratively in a fast-paced environment
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 skills in German and English
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

Clinical Research Associate II

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

Location

Taiwan , Taipei

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Site Management 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
Sound problem solving skills
Able to take initiative and work independently
Advance 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
Willingness to work in a matrix environment

Job Responsibility

Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites
Build relationships with investigators and site staff
Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements
Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up
Address and resolve issues at sites
Follow-up on and respond to appropriate site related questions
Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues
Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections
Collect, review, and approve updated/amended site documentation
Evaluate site recruitment plan in collaboration with the site staff

Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Mountain Home

Salary:

88000.00 - 110000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Minimum associate’s degree required
Bachelor’s of Science strongly preferred
At least 5 years of operations or quality experience, with leadership experience highly preferred
Ability to generate reports, trend performance, and perform data analysis for quality systems
Strong interpersonal communication and leadership skills
Self-motivated with the ability to handle a variety of tasks
Reliable attendance is essential, with the possibility of overtime work, including nights and weekends
Ability to use hands and fingers to manipulate office equipment
Capability to stand and walk for extended periods
Ability to lift up to 40 lbs

Job Responsibility

Possess detailed knowledge of GMP/QSR, ISO requirements, Corporate Quality Manual (CQM), SOP's, specifications, and in-process and final release requirements
Demonstrate excellent communication skills, both written and spoken, for presentations, classroom instruction, and generating reports, memos, and project status updates
Apply direct technical and organizational management skills to initiate, implement, complete, and sustain subordinate activities and behaviors
Implement and ensure compliance of manufacturing and quality control operations with corporate specifications, SOPs, and Good Manufacturing Practices/Quality System Regulations
Take direct responsibility for the plant pest control program, including coordinating with pest control vendors and performing regular inspections and annual reports
Participate in or manage quality assessments of suppliers to analyze compliance and assess risk
Frequently interact with subordinate supervisors and functional peer group managers
Coordinate the plant calibration program, partnering with maintenance staff on calibrations and preparing monthly completion reports for management review
Coordinate the site visual inspection program and continuous process verification (CPV)
Engage directly with auditors regarding pest control, calibrations, visual inspection, critical systems, and CPV

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Mountain Home

Salary:

88000.00 - 110000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Minimum associate’s degree required
Bachelor’s of Science strongly preferred
At least 5 years of operations or quality experience, with leadership experience highly preferred
Ability to generate reports, trend performance, and perform data analysis for quality systems
Strong interpersonal communication and leadership skills
Self-motivated with the ability to handle a variety of tasks
Reliable attendance is essential, with the possibility of overtime work, including nights and weekends
Ability to use hands and fingers to manipulate office equipment
Capability to stand and walk for extended periods
Ability to lift up to 40 lbs

Job Responsibility

Possess detailed knowledge of GMP/QSR, ISO requirements, Corporate Quality Manual (CQM), SOP's, specifications, and in-process and final release requirements
Demonstrate excellent communication skills, both written and spoken, for presentations, classroom instruction, and generating reports, memos, and project status updates
Apply direct technical and organizational management skills to initiate, implement, complete, and sustain subordinate activities and behaviors
Implement and ensure compliance of manufacturing and quality control operations with corporate specifications, SOPs, and Good Manufacturing Practices/Quality System Regulations
Take direct responsibility for the plant pest control program, including coordinating with pest control vendors and performing regular inspections and annual reports
Participate in or manage quality assessments of suppliers to analyze compliance and assess risk
Frequently interact with subordinate supervisors and functional peer group managers
Coordinate the plant calibration program, partnering with maintenance staff on calibrations and preparing monthly completion reports for management review
Coordinate the site visual inspection program and continuous process verification (CPV)
Engage directly with auditors regarding pest control, calibrations, visual inspection, critical systems, and CPV

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Quality Associate II

As a Quality Associate II, you will have the outstanding opportunity to lead all...

Location

United States , Mountain Home

Salary:

88000.00 - 110000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Minimum associate’s degree required
Bachelor’s of Science strongly preferred
At least 5 years of operations or quality experience, with leadership experience highly preferred
Ability to generate reports, trend performance, and perform data analysis for quality systems
Strong interpersonal communication and leadership skills
Self-motivated with the ability to handle a variety of tasks
Reliable attendance is essential, with the possibility of overtime work, including nights and weekends
Ability to use hands and fingers to manipulate office equipment
Capability to stand and walk for extended periods
Ability to lift up to 40 lbs

Job Responsibility

Possess detailed knowledge of GMP/QSR, ISO requirements, Corporate Quality Manual (CQM), SOP's, specifications, and in-process and final release requirements
Demonstrate excellent communication skills, both written and spoken, for presentations, classroom instruction, and generating reports, memos, and project status updates
Apply direct technical and organizational management skills to initiate, implement, complete, and sustain subordinate activities and behaviors
Implement and ensure compliance of manufacturing and quality control operations with corporate specifications, SOPs, and Good Manufacturing Practices/Quality System Regulations
Take direct responsibility for the plant pest control program, including coordinating with pest control vendors and performing regular inspections and annual reports
Participate in or manage quality assessments of suppliers to analyze compliance and assess risk
Frequently interact with subordinate supervisors and functional peer group managers
Coordinate the plant calibration program, partnering with maintenance staff on calibrations and preparing monthly completion reports for management review
Coordinate the site visual inspection program and continuous process verification (CPV)
Engage directly with auditors regarding pest control, calibrations, visual inspection, critical systems, and CPV

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

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Site Management Associate II

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