Clinical Site Manager II Job at iconplc (Paris)

Senior Clinical Site Manager

Senior Clinical Site Manager (SCRA) – Home-Based | Adelaide or Melbourne | Rare ...

Location

Australia , Melbourne

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Experience as a CRA II or Senior CRA within a CRO, biotech, or pharmaceutical environment
Strong site-facing experience with proven ability to build and maintain relationships
Excellent problem-solving skills and ability to think creatively to overcome recruitment challenges
High attention to detail with experience reviewing data and identifying site issues
Outstanding communication skills with the ability to adapt style across different audiences
Solid knowledge of ICH-GCP and clinical trial processes
Ability to work independently in a fast-paced, global environment

Job Responsibility

Build, develop, and maintain strong relationships with investigators and site staff
Lead all aspects of site management, including selection, initiation, monitoring, and close-out visits
Identify site performance trends and proactively address recruitment or operational challenges
Review data and site metrics to identify risks and implement solutions
Act as the primary point of contact for study sites
Support study delivery through collaboration with Project Managers, vendors, and internal teams
Contribute to study start-up activities, documentation, and regulatory submissions
Ensure studies remain audit and inspection ready at all times
Drive innovative approaches to improve site engagement and patient recruitment

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

Parttime

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 (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

Computational Health Informatics Data Manager II - Faja Lab

The Faja Lab within the Laboratories of Cognitive Neuroscience is seeking a full...

Location

United States , Brookline

Salary:

55369.60 - 88576.80 USD / Year

Boston Children's Hospital

Expiration Date

Until further notice

Requirements

Bachelor’s degree in neuroscience, data/computer science, statistics, bioinformatics, or health-sciences related field.
Master’s degree highly preferred.
At least two years of data management or equivalent experience in a healthcare or clinical research environment.
Minimum of 2-year commitment.
Familiarity with established clinical data repositories and Electronic Data Capture systems like REDCap for data types including but not limited to clinical assessment, electronic health record, electroencephalography, digital biomarkers, and biospecimens.
Experience with relevant data analysis environments (e.g., RStudio, Jupyter) and preprocessing software.
Expertise managing and sharing data in collaborative environments.
Full understanding of scientific research processes and principles of Open Science, reproducibility, and FAIR data practices.
Exceptional organizational and problem-solving skills, with the ability to manage multiple parallel workflows in a fast-paced environment.
Familiarity with best practices for HIPAA data security.

Job Responsibility

Manage the design, functionality, implementation, and validation of multimodal data collection workflows and infrastructure.
Perform data transfers and ensure BCH’s alignment with consortium-centralized data transfer, analysis pipelines, computational models, and standardized processing tools.
Comply with HIPAA data security and data sharing guidelines working with approved data transfer methods.
Meet capture and upload timelines, initial quality control thresholds, version control, detailed metadata documentation, and cloud integration as determined by the data coordinating core of the wider research consortium.
Participate in regular consortium meetings with stakeholders and other data managers for cross-site troubleshooting and coordination.
Communicate with consortium members during processing, harmonization, and quality control until datasets are finalized for further release to a long-term data repository.
Support troubleshooting for wearable devices including acquisition and quality checks.
Securely store data collected from research studies, including via REDCap and data repositories.
Develop scripts and automated pipelines for cleaning, preprocessing, and statistical analysis of data for funding requirements and deliverables.

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

Start Up Project Manager II- FSP

The Start Up Project Manager is responsible for defining, developing and deliver...

Location

Canada

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Demonstrated clinical research experience
Demonstrated start up experience
Demonstrated project management experience
Global start up experience (Exposure across a minimum of North America, Asia and Europe) across multiple therapeutic areas
Concurrent management of complex processes within and across countries in multiple regions of the world
Technical expertise in the use of software for the management of clinical studies (enterprise project management, off the shelf and custom built) including reporting systems (dashboards with associated medium to complex data analysis)
Expert ability to comprehend status and adapt communications across a diverse audience
Perform critical path analysis across multiple related project plans, will use key performance indicators to assist in driving overall delivery to operational plan across roles
Will use generative artificial intelligence techniques in daily work
Uses risk management techniques as standard to identify and mitigate key project delivery risks

Job Responsibility

Partner with country / site feasibility specialists to incorporate up to date intelligence for the planned countries and sites into the overall start up strategy and site activation plan, most typically on studies with a medium to large country and site footprint
Partner and co-ordinate across teams responsible for regulatory submissions (local and country) and start up functions (e.g. site essential document collection, site contracts and budgets) to align country and site activities, will have ability to form a robust startup strategy and site activation plan for operationally complex studies
The SUPM is responsible for delivering site activations to plan, for the SUPM II this will generally be for studies with higher operational complexity (based on a combination of factors such study design, country and site footprint and the priority of the study)
As part of the responsibility of delivering site activations to plan the SUPM will co-ordinate with many different roles working at the study and country level to oversee progress of the study specific (e.g. Vendor set-up, investigational product supply etc.) or country specific tasks (e.g. Regulatory submissions, importer of record for supplies etc.) that need to be completed in order for site activations in turn to complete
Provide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start up activities for a study
Lead start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles with the endorsed trial optimization plan (by senior leadership)
The SUPM will work with country level start up roles to seek opportunities to accelerate site activations for their study
Accountable for quality and completeness of start up timeline plans at study, country and site level within an enterprise project management (EPM) system
Responsible for creating and overseeing the initial baseline and subsequent snapshots of timeline planning within the EPM system
In conjunction with study management roles is responsible for ensuring consistent participant compensation for sites and institutions taking part in multiple studies concurrently to eliminate knock-on impact across studies

Care Center Manager II - Phoenix/Avondale

Care Center Manager role is part of a team-based approach in providing advanced ...

Location

United States , Phoenix

Salary:

Not provided

Blue Cross Blue Shield of Arizona

Expiration Date

Until further notice

Requirements

High School Diploma
3 years in healthcare management directly serving patients
BLS Certification required within 30 days of hire
Excellent patient or customer service and communication skills
Proficient PC skills

Job Responsibility

Under the direction of the Director of Operations, and in partnership with the Care Center lead physician and the executive leadership team, this person will be responsible for and facilitates day-to-day clinical operations within the Care Center, including facility opening and closing, managing patient, staff and provider interactions and overall operations
Oversee the operational efficiency and quality of care center services, including direct supervision of medical assistants and patient experience coordinators and other staff as determined by the Director of Operations
Manages and oversees human resources functions, such as hiring, onboarding, and training, and ongoing performance management to build and develop a high-performing team committed to service excellence
Collaborate closely with the Care Center team to ensure the Care Center's performance in effective value-based care and are aligned with Key Performance Indicators (KPIs)
In cooperation with Care Center team, ensures staff meetings and huddles meet Prosano's 'Healthy Huddle' experience standards
Oversee systems and processes vital to the Care Center operations, including scheduling, workflow, and supply management systems
Be an ambassador in the local community - building relationships with other healthcare providers, social/community organizations, and marketing partners
Other duties as assigned
Working hours may include extended hours
This position requires 100% on-site work at the care center location and may also involve movement between clinics as needed

Fulltime

Global Study Manager II

Parexel is actively recruiting for an experienced Global Study Manager to join u...

Location

Poland

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor’s degree and minimum 6 years of relevant global study management/leadership experience
Experience with oversight of CROs and vendors
Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend
Fluency in written and spoken English required
Ability to work outside of core business hours, as required, to support global trials or initiatives
Ability to travel, as required, including IMs, vendor kick off and re-set meetings, and client internal global or department level meetings
Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS
Knowledge of ICH GCP and relevant regulatory guidelines/directives
Demonstrated interpersonal & leadership skills
Ability to understand and implement the strategic direction and guidance for respective clinical studies

Job Responsibility

Provide leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s
Steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders, and team members on a global, multi country or regional basis
Accountable for the accurate planning and operational feasibility of trial timelines
and oversight of trial preparation to ensure trial team members are aligned and on track
Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring)
Verifies and provides input into the country allocation and oversees trial feasibility
Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements
compliance with SOPs and continuous risk monitoring/mitigation
In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting
Prepare and implement amendments of core documents, including training material updates/retraining as needed

Fulltime

Global Study Manager II

Parexel is actively recruiting for an experienced Global Study Manager to join u...

Location

Poland; Spain; Serbia; Romania

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree and minimum 6 years of relevant global study management/leadership experience
Experience with oversight of CROs and vendors
Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend
Fluency in written and spoken English required
Ability to work outside of core business hours, as required, to support global trials or initiatives
Ability to travel, as required, including IMs, vendor kick off and re-set meetings, and client internal global or department level meetings
Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS
Knowledge of ICH GCP and relevant regulatory guidelines/directives
Demonstrated interpersonal & leadership skills
Ability to understand and implement the strategic direction and guidance for respective clinical studies

Job Responsibility

Provides leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI's
Steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders, and team members on a global, multi country or regional basis
Accountable for the accurate planning and operational feasibility of trial timelines
and oversight of trial preparation to ensure trial team members are aligned and on track
Verifies and provides input into the country allocation and oversees trial feasibility
Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements
compliance with SOPs and continuous risk monitoring/mitigation
In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting
Prepare and implement amendments of core documents, including training material updates/retraining as needed
Support authority/ethics response to requests as applicable

Fulltime

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Clinical Site Manager II

Job Description

Job Responsibility

Requirements

What we offer

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