Chicago, IL · On-site
$55K - $70K/yr
Act as the single point of contact from Tempus for JIT and expedited site activations, including maintaining site activation timelines and answering study start-up related questions. * Coordinate ...
Chicago, IL · On-site
$55K - $70K/yr
Act as the single point of contact from Tempus for JIT and expedited site activations, including maintaining site activation timelines and answering study start-up related questions. * Coordinate ...
Chicago, IL · On-site
$55K - $70K/yr
Act as the single point of contact from Tempus for JIT and expedited site activations, including maintaining site activation timelines and answering study start-up related questions. * Coordinate ...
Chicago, IL · On-site
$55K - $70K/yr
Act as the single point of contact from Tempus for JIT and expedited site activations, including maintaining site activation timelines and answering study start-up related questions. * Coordinate ...
$55K - $70K/yr
Act as the single point of contact from Tempus for JIT and expedited site activations, including maintaining site activation timelines and answering study start-up related questions. * Coordinate ...
$55K - $70K/yr
Act as the single point of contact from Tempus for JIT and expedited site activations, including maintaining site activation timelines and answering study start-up related questions. * Coordinate ...
Chicago, IL · On-site
$55 - $70/hr
Deep understanding of study start-up and site activation. * Knowledge of current FDA regulations, Good Clinical Practices governing clinical research, and HIPAA compliance. * Strong project ...
Chicago, IL · On-site
$55 - $70/hr
Deep understanding of study start-up and site activation. * Knowledge of current FDA regulations, Good Clinical Practices governing clinical research, and HIPAA compliance. * Strong project ...
Regulatory Start-Up Specialist The Regulatory Start-Up Specialist serves as the main point of contact for project-specific study start-up activities within the regulatory department and provides ...
Regulatory Start-Up Specialist The Regulatory Start-Up Specialist serves as the main point of contact for project-specific study start-up activities within the regulatory department and provides ...
$83K - $113K/yr
Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne's SOPs, and local regulations.
$83K - $113K/yr
Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne's SOPs, and local regulations.
Conshohocken, PA · On-site
Study Start-Up Manager 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 ...
Conshohocken, PA · On-site
Study Start-Up Manager 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 ...
Wilmington, DE · On-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 ...
Wilmington, DE · On-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 ...
Houston, TX · On-site
Study Start-Up Manager 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 ...
Houston, TX · On-site
Study Start-Up Manager 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 ...
Cary, NC · On-site
Study Start-Up Manager 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 ...
Cary, NC · On-site
Study Start-Up Manager 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 ...
Philadelphia, PA · On-site
Study Start-Up Manager 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 ...
Philadelphia, PA · On-site
Study Start-Up Manager 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 ...
Dallas, TX · On-site
Study Start-Up Manager 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 ...
Dallas, TX · On-site
Study Start-Up Manager 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 ...
Watertown, MA · On-site
$195K - $275K/yr
Provide strategic and operational leadership for end-to-end study start-up activities across assigned clinical programs, ensuring timely, compliant, and high-quality site activation. * Accountable ...
Watertown, MA · On-site
$195K - $275K/yr
Provide strategic and operational leadership for end-to-end study start-up activities across assigned clinical programs, ensuring timely, compliant, and high-quality site activation. * Accountable ...
Portland, ME · On-site
Description JOB SUMMARY The Study Start-up Lead (SSUL) reports to the Global Feasibility ... Ensure all assigned SSU Specialists are adequately trained on project specific systems and ...
Portland, ME · On-site
Description JOB SUMMARY The Study Start-up Lead (SSUL) reports to the Global Feasibility ... Ensure all assigned SSU Specialists are adequately trained on project specific systems and ...
Wilmington, DE · On-site
Are you ready to lead country-level study start-up that turns bold science into real treatments faster. In this role, you will accelerate site activations, shape regulatory and ethics submissions ...
Wilmington, DE · On-site
Are you ready to lead country-level study start-up that turns bold science into real treatments faster. In this role, you will accelerate site activations, shape regulatory and ethics submissions ...
... specialist assigned to the study regarding EC /CA outcomes * Accurately apply naming conventions, upload and process all correct and complete study documentation in the study start-up module or ...
New
... specialist assigned to the study regarding EC /CA outcomes * Accurately apply naming conventions, upload and process all correct and complete study documentation in the study start-up module or ...
New
Wilmington, DE · On-site
Are you ready to lead country-level study start-up that turns bold science into real treatments faster? In this role, you will accelerate site activations, shape regulatory and ethics submissions ...
Wilmington, DE · On-site
Are you ready to lead country-level study start-up that turns bold science into real treatments faster? In this role, you will accelerate site activations, shape regulatory and ethics submissions ...
Wilmington, DE · On-site
Are you ready to lead country-level study start-up that turns bold science into real treatments faster? In this role, you will accelerate site activations, shape regulatory and ethics submissions ...
Wilmington, DE · On-site
Are you ready to lead country-level study start-up that turns bold science into real treatments faster? In this role, you will accelerate site activations, shape regulatory and ethics submissions ...
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
Quick apply
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
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
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
$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:
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
Responsibilities:
Act as the single point of contact from Tempus for JIT and expedited site activations, including maintaining site activation timelines and answering study start-up related questions.
Coordinate with TIME sites and sponsor teams to activate clinical trials through the JIT and expedited activation process in order to enroll eligible patients.
Collaborate with the central IRB team to facilitate IRB review and approval.
Attend bi-weekly meetings with the central IRB team
Educate TIME sites and sponsor partners on the JIT and expedited activation processes and best practices.
Attend Rapid Activation Demos for onboarding TIME sites
Attend standing meetings with TIME sites to review site activation process and ongoing activations
Attend sponsor KOMs (where applicable)
Attend standing meetings with sponsors to review ongoing site activations (where applicable)
Contribute to relationships with TIME sites and pharmaceutical/ CRO partners in the TIME program.
Support the team performing feasibility, activations, and other activities within the start up processes.
Develop and implement new products, services, and workflows to drive efficiencies throughout the SSU and TIME team.
Contribute to the development of marketing collateral for the TIME program.
Administrative tasks associated with the activities listed above.
Minimum Qualifications:
Bachelor's degree in science or health related field.
2+ years of experience working as a clinical research coordinator in oncology or experience working for a pharmaceutical company/CRO.
Deep understanding of study start-up and site activation.
Knowledge of current FDA regulations, Good Clinical Practices governing clinical research, and HIPAA compliance.
Strong project management skills, with the ability to set goals and prioritize and manage multiple projects simultaneously.
Excellent organization and written/ oral communication skills with high attention to detail and accuracy.
Ability to develop and maintain strong relationships.
Superior analytical, interpersonal, and problem-solving skills.
CCRC preferable
Proficient in the use of MS Office applications (Outlook, Word, Excel, PowerPoint).
#LI-DA1
$55,000-$70,000
The expected salary range may vary for other locations. Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
