Cary, NC · On-site
$31 - $42.50/hr
Study Start-Up Specialist (Sponsor Dedicated) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
New
Cary, NC · On-site
$31 - $42.50/hr
Study Start-Up Specialist (Sponsor Dedicated) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
New
Philadelphia, PA · On-site
$33.75 - $46.25/hr
Study Start-Up Specialist (Sponsor Dedicated) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
New
Philadelphia, PA · On-site
$33.75 - $46.25/hr
Study Start-Up Specialist (Sponsor Dedicated) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
New
Philadelphia, PA · On-site
$33.75 - $46.25/hr
Study Start-Up Specialist (Sponsor Dedicated) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
New
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Philadelphia, PA · On-site
$33.75 - $46.25/hr
Study Start-Up Specialist (Sponsor Dedicated) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
New
South San Francisco, CA · On-site
$70 - $75/hr
Drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials. * Enable innovative clinical trial delivery and address study start-up needs across various ...
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South San Francisco, CA · On-site
$70 - $75/hr
Drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials. * Enable innovative clinical trial delivery and address study start-up needs across various ...
Cary, NC · On-site
$31 - $42.50/hr
Study Start-Up Specialist (Sponsor Dedicated) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
New
Quick apply
Cary, NC · On-site
$31 - $42.50/hr
Study Start-Up Specialist (Sponsor Dedicated) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
New
Raleigh, NC · On-site
$32.50 - $44.50/hr
Study Start-Up Specialist (Sponsor Dedicated) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
New
Quick apply
Raleigh, NC · On-site
$32.50 - $44.50/hr
Study Start-Up Specialist (Sponsor Dedicated) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
New
North Wales, PA · On-site
$32.50 - $44.25/hr
Study Start-Up Specialist (Sponsor Dedicated) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
New
North Wales, PA · On-site
$32.50 - $44.25/hr
Study Start-Up Specialist (Sponsor Dedicated) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
New
Pittsburgh, PA · On-site
$32.50 - $44.50/hr
Study Start-Up Specialist (Sponsor Dedicated) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
New
Pittsburgh, PA · On-site
$32.50 - $44.50/hr
Study Start-Up Specialist (Sponsor Dedicated) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
New
Princeton, NJ · On-site
The ideal candidate will have extensive experience in feasibility, study start-up, site contact and budget negotiation, and managing relationships with clinical research sites. You will support ...
Princeton, NJ · On-site
The ideal candidate will have extensive experience in feasibility, study start-up, site contact and budget negotiation, and managing relationships with clinical research sites. You will support ...
Summary We are looking for a Study Start-Up Manager with extensive experience to lead clinical study start-up activities. This role requires a strong background in regulatory processes, site ...
Summary We are looking for a Study Start-Up Manager with extensive experience to lead clinical study start-up activities. This role requires a strong background in regulatory processes, site ...
The Senior Manager, Study Start-up partners closely with the Clinical Operations study team leading global study start-up and site activation activities in Phase I-III and real-world evidence ...
The Senior Manager, Study Start-up partners closely with the Clinical Operations study team leading global study start-up and site activation activities in Phase I-III and real-world evidence ...
Summary We are looking for a Study Start-Up Manager with extensive experience to lead clinical study start-up activities. This role requires a strong background in regulatory processes, site ...
Summary We are looking for a Study Start-Up Manager with extensive experience to lead clinical study start-up activities. This role requires a strong background in regulatory processes, site ...
Study Start-Up/Regulatory Submissions experience within a CRO is required. Incentives can include: Competitive bonus program, sign-on/relocation bonus, and equity awards. Location: Position can be ...
Study Start-Up/Regulatory Submissions experience within a CRO is required. Incentives can include: Competitive bonus program, sign-on/relocation bonus, and equity awards. Location: Position can be ...
Study Start-Up/Regulatory Submissions experience within a CRO is required. Incentives can include: Competitive bonus program, sign-on/relocation bonus, and equity awards. Location: Position can be ...
Study Start-Up/Regulatory Submissions experience within a CRO is required. Incentives can include: Competitive bonus program, sign-on/relocation bonus, and equity awards. Location: Position can be ...
CO · On-site +1
Study Start-Up/Regulatory Submissions experience within a CRO is required. Incentives can include: Competitive bonus program, sign-on/relocation bonus, and equity awards. Location: Position can be ...
CO · On-site +1
Study Start-Up/Regulatory Submissions experience within a CRO is required. Incentives can include: Competitive bonus program, sign-on/relocation bonus, and equity awards. Location: Position can be ...
Maintain timelines for study start-up through both internal and external collaboration; and * Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and ...
Maintain timelines for study start-up through both internal and external collaboration; and * Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and ...
Cincinnati, OH · On-site +1
Maintain timelines for study start-up through both internal and external collaboration; and * Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and ...
Cincinnati, OH · On-site +1
Maintain timelines for study start-up through both internal and external collaboration; and * Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and ...
Lead the operational execution of clinical studies from start-up through close-out, including site initiation, enrollment, monitoring, and close-out activities. Develop and manage study timelines ...
Lead the operational execution of clinical studies from start-up through close-out, including site initiation, enrollment, monitoring, and close-out activities. Develop and manage study timelines ...
Cincinnati, OH · On-site
This group plays a key role in the study start-up/site activation process at Medpace by communicating with research sites (doctor's offices, universities, hospitals, etc.) to collect all essential ...
Cincinnati, OH · On-site
This group plays a key role in the study start-up/site activation process at Medpace by communicating with research sites (doctor's offices, universities, hospitals, etc.) to collect all essential ...
Cary, NC · On-site
$70 - $95/hr
Study Start-Up Specialist (Sponsor Dedicated) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation ...
New
Cary, NC · On-site
$70 - $95/hr
Study Start-Up Specialist (Sponsor Dedicated) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation ...
New
$11.30 - $17.07
13% of jobs
$22.28 is the 25th percentile. Wages below this are outliers.
$17.07 - $22.84
14% of jobs
$22.84 - $28.61
12% of jobs
The median wage is $32.29 / hr.
$28.61 - $34.38
19% of jobs
$38.90 is the 75th percentile. Wages above this are outliers.
$34.38 - $40.14
23% of jobs
$40.14 - $45.91
3% of jobs
$45.91 - $51.68
2% of jobs
$51.68 - $57.45
2% of jobs
$57.45 - $63.22
1% of jobs
$63.22 - $68.99
4% of jobs
$68.99 - $74.76
7% of jobs
$11
$36
$74
A Study Start Up (SSU) Specialist is responsible for managing the initial stages of clinical trials, including regulatory submissions, ethics committee approvals, site contract negotiations, and essential document collection. They work closely with sponsors, clinical research organizations (CROs), and investigative sites to ensure compliance with regulatory requirements and timelines. Their role is critical in minimizing delays and ensuring that clinical trials start efficiently and successfully. Strong attention to detail, knowledge of regulatory guidelines, and effective communication skills are essential for success in this position.
A Study Start Up Specialist is primarily responsible for coordinating and facilitating all activities required to initiate clinical trials, including preparing regulatory submissions, managing essential documents, and ensuring timelines are met for site activation. You'll routinely interact with clinical research sites, regulatory authorities, and cross-functional teams to address submission queries, resolve compliance issues, and track progress. This role often involves reviewing site contracts, budgets, and regulatory binders, as well as updating systems to reflect study milestones. Candidates who excel in this position are highly organized, thrive in a fast-paced setting, and enjoy troubleshooting regulatory or operational challenges to keep studies moving forward.
To thrive as a Study Start Up Specialist, you need a background in clinical research, project management, and regulatory compliance, often supported by a bachelor's degree in life sciences or a related field. Familiarity with clinical trial management systems (CTMS), electronic trial master files (eTMF), and knowledge of ICH-GCP guidelines and regulatory requirements are essential. Outstanding organizational skills, attention to detail, and proactive communication help candidates excel in this collaborative, deadline-driven environment. These skills ensure smooth study initiation, regulatory accuracy, and effective coordination across stakeholders to keep drug development projects on track.
Cities with the most Study Start Up Specialist job openings:
States with the most job openings for Study Start Up Specialist jobs include:
The top searched job categories for Study Start Up Specialist jobs are:
$31 - $42.50/hr
Full-time
Medical, Dental, Vision, Life, Retirement
Posted 2 days ago
New
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
What you will be doing
Support the day-to-day operations of assigned activities within SSU to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives
Generate and provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools
Proactively identify and escalate issues that arise related to support SSU deliverables
Effectively execute against assigned activities within SSU
Support implementation of standards for global SSU team
This may include:
Oversight of site level SSU activities from receipt of a potential site list to site activation under the direction of a Global SSU Manager including CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP Release and other site activation requirements
Implementation of the SSU Strategy for assigned region during the study start up period
Building relationships with internal counterparts and site staff to support successful site activation strategies
Projecting site activation timelines and appropriately escalating when things get off track
Adhering to process and tools designed to the support of the SSU team with day-to-day activities
Leading the preparation of study level essential document templates
Aiding in the preparation of content for Regulatory submissions
Handling ICF negotiations and facilitating any required escalations
Preparation and submission of IMP Release Packages
Maintaining accurate and timely information in relevant clinical systems
Responsible for complying with regulations and guidelines and ensuring adherence in support of assigned clinical trials. This position has no direct reports but may provide guidance/oversight to contract staff.
Your profile
BS/BA degree or Associates degree with 2 years of experience in clinical trial related start-up experience.
ICF negotiation experience
Must have knowledge of clinical trial conduct
General knowledge of drug development and ICH/GCP guidelines
Requires proven project management skills
Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
Fluent in English.
Minimal (0-5%) travel required
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a requesthere.
Are you a current ICON Employee? Please click here to apply
