Study Startup Associate I Job at iconplc (Buenos Aires)

Country Study Operations Manager I

The Study Operations Manager I (SOM I) has responsibilities for study and region...

Location

Canada

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Expertise in the use of study and site dashboards and reporting tools
Detail oriented and possesses technical expertise
Ability to manage moderately complex processes
Risk identification and mitigation, strategic planning, and critical path analysis skills
Analytical and problem solving skills
Ability to adapt to changing technologies and processes, work independently and exercise own judgement
Supportive of an environment where innovation is standard, including developing ideas and taking appropriate risks to advance innovative processes
Effective verbal and written communication skills in relating to colleagues and associates, both inside and outside of the organization
Ability to operate in a matrix environment
Fluency in written and spoken English required

Job Responsibility

Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverables
Serves as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studies
Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
May manage the study start up process in countries assigned [where the Start Up Project Manager (SUPM) is not assigned] and/or oversee the pCRO responsible for these activities as applicable
Liaises with SCP, Lead SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethic Committees (ECs)
Provides country level input on startup and recruitment milestones as provided by pCRO and/or CTM/SCP to GSM during planning
Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required
Accountable for resolution of site activation escalations to study teams including offering options for mitigation
May be responsible and accountable for, as designated by the GSM: Regional, country and study level implementation of startup and site activation plans (through SUPM or pCRO if assigned)
Regional, country and study level recruitment strategy

Fulltime

Senior Clinical Trial Manager

Senior Local Operations Manager - Hematology Oncology - Home Based. ICON plc is ...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS degree
Degree in a health or science related field
3 - 5+ years of trial end to end management experience
Hematology Oncology experience required
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
Strong IT skills in appropriate software and company systems
Proficient in speaking and writing the country language and English
Good written and oral communication skills as appropriate
To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
Owns relationships with critical site stakeholders to provide a voice for the site to the client's teams
Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report
Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget
Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial
Focuses on investigator engagement through timely follow up with sites
Drive study compliance by maintaining and updating trial management systems
Contribute to site level recruitment strategy and contingency planning and implementation
Delivers competent vendor management at the country level to support the study
Ensures high standards for study monitoring by conducting quality local trial team meetings

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
Global Employee Assistance Programme, LifeWorks
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 Clinical Trial Manager

Senior Local Operations Manager - Oncology - Home Based. ICON plc is a world-lea...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS degree
Degree in a health or science related field
3 - 5+ years of trial end to end management experience
Solid Tumor Oncology experience required
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
Strong IT skills in appropriate software and company systems
Proficient in speaking and writing the country language and English
Good written and oral communication skills
To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams
Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report
Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs
Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial
Focuses on investigator engagement through timely follow up with sites
Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress
Contribute to site level recruitment strategy and contingency planning and implementation
Delivers competent vendor management at the country level
Ensures high standards for study monitoring by conducting quality local trial team meetings

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
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Senior Clinical Trial Manager

Sr Local Trial Manager – Solid Tumor Oncology - Home Based (US) ICON plc is a wo...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS degree
Degree in a health or science related field
3 - 5+ years of trial end to end management experience
Solid Tumor Oncology experience required
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
Strong IT skills in appropriate software and company systems
Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate
To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams
Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report
Collaborates with central study team and local stakeholders as applicable for final selection of sites to participate in trial
Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations
Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial
Focuses on investigator engagement through timely follow up with sites
Promptly communicates relevant status information and issues to appropriate stakeholders
Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress
When necessary initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams and Quality & Compliance team

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

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

Process Safety Engineer

Location

United States , Artesia

Salary:

Not provided

HF Sinclair

Expiration Date

Until further notice

Requirements

A minimum of two years of progressive work experience in a specific engineering discipline. A strong understanding of basic refinery processes and the elements of process safety is required for Process Safety Engineering discipline. A minimum of a Bachelor's Degree in an Engineering discipline is required. Intermediate level of knowledge of OSHA PSM regulations and critical Process Safety activity. Working knowledge of Microsoft products. Working knowledge of science, basic refinery operations, and maintenance and engineering practices. Advanced verbal and written communication and interpersonal skills. Goal-oriented and organized.

Job Responsibility

Provides support to facility personnel to increase understanding of process safety elements and procedures, in order to promote effective implementation of the PSM program
Monitors performance to ensure that process safety goals are achieved
Participates in risk assessment studies, process hazard analysis, and layers-of-protection analysis evaluations
Supports the Management of Change and Pre-Startup Safety Review programs
Monitors/tracks all capital and expense budget items associated to the PSM Dept
Coordinates and track flare and relief system improvements
Coordinates and facilitate incident investigations
Works with Process Safety dept. to assist in developing and implementing procedures and programs to ensure compliance with company policies and guidelines, government regulations, and industry standards
Tracks and completes all open PSM items in a timely manner, also be a resource to other employees to get their items completed on time
Monitors industry trends to assure that the Refinery is up to date with industry

What we offer

Medical Insurance
Vision Insurance
Dental Insurance
Paid Time-Off
401(k) Retirement Plan with match
Educational Reimbursement
Parental Bonding Time
Employee Discounts

Fulltime

Junior Systems Design Engineer - Nuclear

As a Junior Systems Design Engineer – Nuclear, you will play a key role in the d...

Location

United States , Lewis Center

Salary:

Not provided

ATS Automation Tooling Systems Inc.

Expiration Date

Until further notice

Requirements

Associate’s degree in mechanical engineering, Systems Design Engineering, Electrical Engineering, Mechatronics, Engineering Physics, Engineering Science, or a related engineering discipline
Academic exposure to systems engineering principles, design methodology, analysis, and verification
Coursework or project experience related to nuclear, energy, regulated industries, or high reliability systems
Early career experience (internship, co-op, or entry level role) supporting mechanical, electrical, controls, or systems engineering activities
Fundamental understanding of engineering design, analysis, and structured problem solving methodologies
Exposure to requirements definition, technical documentation, or verification and validation activities
Ability to support basic engineering calculations, analyses, and studies
Familiarity with interpreting engineering drawings, specifications, and technical documents
Hands on interest or experience in testing, prototyping, proof of principle activities, or system integration support
Working knowledge of Microsoft Office tools (Word, Excel, PowerPoint)

Job Responsibility

Supports the Development of System Requirements Definition and Verification
Assist in the development, documentation, and maintenance of system level requirements
Support requirements flow down to subsystems, components, and third party equipment
Participate in requirements verification planning and execution
Assist with the preparation and execution of acceptance testing activities
Evaluate design outputs for conformance to defined requirements
Support the preparation of technical documentation
Assist in the identification and mitigation of technical risks
Learn and develop an understanding of customer processes, system functionality, and applicable nuclear and industrial standards
Support system level and component level analysis and calculations

What we offer

Flexible work schedules
Employee events
Free coffee beverages
Employee referral program
Safety shoe programs
Overtime pay eligibility
Paid vacation
Company paid short- and long-term disability and life insurance
Comprehensive health benefits
401K matching program

Fulltime

Senior Associate, Insights - Strategy & Operations

Our Advertising & Promotions team operates at the intersection of e-commerce and...

Location

United States , San Francisco, CA; New York, NY; Seattle, WA; Chicago, IL; Los Angeles, CA; Tempe, AZ; Washington D.C.

Salary:

87000.00 - 128000.00 USD / Year

DoorDash

Expiration Date

Until further notice

Requirements

2-5 years of experience in analytics, consulting, strategy & operations, planning, or operations
high growth startup experience preferred
Intermediate / Advanced SQL experience
Excel and Powerpoint (or Google Sheets and Google Slides) experience
comfortable working across multiple projects & priorities and hitting deadlines
proven track record of delivering insights needed to hit business goals and succeeding in a complex and fast moving environment
experience in media analytics and/or consumer insights
client facing experience
BA/BS degree

Job Responsibility

Manage and execute on campaign and business reporting for our largest advertising partners
Create case studies, deliver insights and be the subject matter expert on all things related to our suite of marketing solutions
Identify trends and develop recommendations to clients & their business
Partner with our Account Management/ Sales teams to better enable their ability to sell
Collaborate with cross functional partners including sales, marketing, analytics, and product

What we offer

401(k) plan with employer matching
16 weeks of paid parental leave
wellness benefits
commuter benefits match
paid time off
paid sick leave
medical, dental, and vision benefits
11 paid holidays
disability and basic life insurance
family-forming assistance

Fulltime

Select Country

Study Startup Associate I

Job Description

Job Responsibility

Requirements

What we offer

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