Study Start Up Lead Job at CK Group (Welwyn Garden City)

Study Start Up Project Manager - FSP

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

Location

Canada , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Country or Regional start up exposure/experience in the countries under responsibility across at least two major therapeutic areas
Technical expertise in use of software (off the shelf and custom) for the management of clinical studies with prowess in using reporting systems (dashboards and associated basic data analysis) to comprehend and communicate status
Ability to use basic generative artificial intelligence techniques in daily work
Will use standard risk management methodology to identify and mitigate key risks
Fluency in English is required
Extensive global start up clinical trial/study management experience
Comprehensive working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
Extensive knowledge of clinical trial methodology
Demonstrated start up experience
Demonstrated project management experience

Job Responsibility

Define, develop and deliver the global start up project strategy by partnering with roles across GSSO, CD&O, Global Regulatory Submissions and others as required
Manage and coordinate study start up activities globally
Lead the start up sub team for the study, region(s) or countries assigned
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
Partner and co-ordinate across teams responsible for regulatory submissions (local and country) and start up functions to align country and site activities
Continually assess current and future workload to proactively anticipate, problem solve and request appropriate changes
Provide project management of activities directly required to complete all site activations
Lead start up meetings that facilitate alignment of site selection to activation activities
Work with country level start up roles to seek opportunities to accelerate site activations
Accountable for quality and completeness of start up timeline plans at study, country and site level

Fulltime

Study Start Up Associate I

Regulatory Exp.- Home Based - CDMX. ICON plc is a world-leading healthcare intel...

Location

Mexico , Mexico City

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or a related field
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements
Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams

Job Responsibility

Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications
Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence
Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities
Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency

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

Manager, Study Start Up

As a Manager, Study Start Up at ICON, you will lead and oversee the start-up act...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant scientific discipline or healthcare-related field
Extensive experience in clinical trial study start-up, with a strong understanding of global regulatory requirements and clinical operations
Proven leadership skills, with experience managing and mentoring teams in a fast-paced, deadline-driven environment
Excellent organizational and project management skills, with the ability to handle multiple studies and priorities simultaneously
Strong communication and stakeholder management skills, with the ability to collaborate effectively with sponsors and internal teams
Experience with process optimization and implementing best practices in study start-up activities
Willingness to travel as required (approximately 25%)

Job Responsibility

Managing and overseeing the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation
Leading a team of study start-up professionals, providing guidance, mentorship, and support to ensure high performance and successful project delivery
Collaborating with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines for clinical trial initiation
Monitoring study start-up metrics, timelines, and budgets to ensure projects are delivered on time and within scope
Identifying potential risks and challenges in the start-up process and implementing strategies to mitigate delays or issues
Driving continuous improvement initiatives to optimize the study start-up process and enhance overall efficiency

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

Study Start Up Associate

Study Start-Up Associate - home-based - South Korea- ICON Strategic Solutions. I...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or a related field
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements
Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams

Job Responsibility

Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications
Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence
Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities
Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency

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

Senior Study Start Up Associate

Senior Study Start Up Associate - São Paulo (FSP - Sponsor Dedicated). ICON plc ...

Location

Brazil , São Paulo

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline
Solid experience or understanding of clinical study start-up requirements and activities
Fluency in the local language and English is essential

Job Responsibility

Efficiently Drive Study Initiation: Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities
Empower Success through Specialized SSU Expertise: Provide expertise to Study Start Up team leads and project teams, providing valuable insights to drive success
Ensuring Regulatory Compliance: Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines
Safeguarding Patient Welfare: Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent

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

Study Start Up Associate II

We are currently seeking a Study Start Up Associate II to join our diverse and d...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or a related field
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements
Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
Initial and Amendment for IRB Submission

Job Responsibility

Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications
Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence
Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities
Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency

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

Study Start-up Manager-South Korea-ICON Strategic Solutions

As a Clinical Trial Manager at ICON, you will manage clinical trial operations a...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

University degree in medicine, science, or equivalent combination of education & experience
Demonstrated ability to drive the clinical deliverables of a study
Subject matter expertise in the designated therapeutic area
Prior monitoring experience is preferred
Willingness to travel as required (approximately 25%)

Job Responsibility

Manage clinical trial operations activities
Plan, execute and report from country feasibility up to and including site initiation for assigned innovative medicines phase I-IV studies
Act as single point of contact and local study team lead within the country/cluster
Support study feasibility and country patient commitments
Lead site selection
Ensure study start-up activities are conducted and completed on time
Oversee local vendor selection and performance
Drive the conduct of the study and track status
Ensure recruitment targets are met
Oversee local clinical team activities

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

Study Start-up Manager

Drive the planning and execution of clinical study start-up activities, ensuring...

Location

United States

Salary:

122229.00 - 150449.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Pharma and clinical trial processes and operations expertise
Experience leading and managing global teams
Project management experience
Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Doctorate degree OR Master’s degree and 3 years of clinical execution experience OR Bachelor’s degree and 5 years of clinical execution experience OR Associate’s degree and 10 years of clinical execution experience OR High school diploma / GED and 12 years of clinical execution experience

Job Responsibility

Lead the planning and delivery of clinical study start-up activities from global to local, ensuring timelines, quality, budget, and regulatory compliance are met
Own and manage study start-up plans and milestones, maintaining oversight of progress and resolving issues to keep delivery on track
Act as the primary point of contact for cross-functional start-up teams, driving clarity of roles, accountability, and collaboration
Identify, assess, and mitigate risks proactively, contributing to study risk assessments and ensuring timely study start
Partner closely with Study Delivery Leads, managers, and local teams, providing clear updates, solutions, and escalation where needed
Apply strong operational and regulatory knowledge (e.g. ICH-GCP, submissions and start-up processes) to enable high-quality execution
Manage internal resources and external suppliers to ensure efficient and compliant delivery of start-up activities
Contribute to continuous improvement by sharing expertise, mentoring colleagues, and developing best practices within the SSU hub

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

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Study Start Up Lead

Job Description

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