Study Leadership: Lead the end-to-end management of multiple clinical studies, including ... Ability to work in a fast-paced, "startup" environment. #LI-NK1 $100,000 - $140,000 The expected ...
Study Leadership: Lead the end-to-end management of multiple clinical studies, including ... Ability to work in a fast-paced, "startup" environment. #LI-NK1 $100,000 - $140,000 The expected ...
(Senior) Clinical Study Manager, Clinical Development
Triangle, VA · On-site
$100K - $140K/yr
Study Leadership: Lead the end-to-end management of multiple clinical studies, including ... Ability to work in a fast-paced, "startup" environment. #LI-NK1 $100,000 - $140,000 The expected ...
(Senior) Clinical Study Manager, Clinical Development
Triangle, VA · On-site
$100K - $140K/yr
Study Leadership: Lead the end-to-end management of multiple clinical studies, including ... Ability to work in a fast-paced, "startup" environment. #LI-NK1 $100,000 - $140,000 The expected ...
Manage clinical trial operations from startup through closeout * Oversee adverse event reporting ... Develop and maintain clinical study documentation * Collaborate with regulatory teams on ...
Quick apply
Manage clinical trial operations from startup through closeout * Oversee adverse event reporting ... Develop and maintain clinical study documentation * Collaborate with regulatory teams on ...
Manage clinical trial operations from startup through closeout Oversee adverse event reporting and ... clinical study documentation Collaborate with regulatory teams on submissions Minimum ...
Manage clinical trial operations from startup through closeout Oversee adverse event reporting and ... clinical study documentation Collaborate with regulatory teams on submissions Minimum ...
Requirements Key Responsibilities: • Manage clinical trial operations from startup through ... clinical study documentation • Collaborate with regulatory teams on submissions Minimum ...
Requirements Key Responsibilities: • Manage clinical trial operations from startup through ... clinical study documentation • Collaborate with regulatory teams on submissions Minimum ...
CRA 1, IQVIA Biotech
$71K - $145K/yr
... clinical research studies by performing site monitoring and site management activities. In this ... startup activities based on study needs. Accurate and timely documentation is critical. The CRA I ...
CRA 1, IQVIA Biotech
$71K - $145K/yr
... clinical research studies by performing site monitoring and site management activities. In this ... startup activities based on study needs. Accurate and timely documentation is critical. The CRA I ...
CRA 1, IQVIA Biotech
Fairfax, VA · On-site
$71K - $145K/yr
... clinical research studies by performing site monitoring and site management activities. In this ... startup activities based on study needs. Accurate and timely documentation is critical. The CRA I ...
CRA 1, IQVIA Biotech
Fairfax, VA · On-site
$71K - $145K/yr
... clinical research studies by performing site monitoring and site management activities. In this ... startup activities based on study needs. Accurate and timely documentation is critical. The CRA I ...
Laboratory Manager
$80K - $90K/yr
... clinical laboratory operations for our new Virginia startup location. As a key member of our team ... Review and approve laboratory policies, procedures, and validation studies * Supervise and support ...
Quick apply
Laboratory Manager
$80K - $90K/yr
... clinical laboratory operations for our new Virginia startup location. As a key member of our team ... Review and approve laboratory policies, procedures, and validation studies * Supervise and support ...
Virginia Remote Patient Monitoring LPN Contractor
Roanoke, VA · On-site +1
$25.50 - $33.75/hr
After running a successful pilot study with results that exceeded all expectations, the team is ... Learn new clinical protocols quickly * Communicate well with both patients and providers * Have ...
Virginia Remote Patient Monitoring LPN Contractor
Roanoke, VA · On-site +1
$25.50 - $33.75/hr
After running a successful pilot study with results that exceeded all expectations, the team is ... Learn new clinical protocols quickly * Communicate well with both patients and providers * Have ...
Senior Director, Commercial Learning and Development and Onboarding
Hampton, VA · On-site
$203.16 - $263.84/hr
... studies in CSU, ColdU, SD and phase 2 studies in AD and PN. We're looking for curious, driven ... Proven ability to create training from scratch in a fast-paced, startup environment * Excellent ...
Senior Director, Commercial Learning and Development and Onboarding
Hampton, VA · On-site
$203.16 - $263.84/hr
... studies in CSU, ColdU, SD and phase 2 studies in AD and PN. We're looking for curious, driven ... Proven ability to create training from scratch in a fast-paced, startup environment * Excellent ...
Clinical Study Startup information
What is a clinical study startup?
A Clinical Study Startup job involves managing the initial phases of a clinical trial, ensuring all regulatory, ethical, and logistical requirements are met before patient enrollment begins. Responsibilities typically include submitting regulatory documents, coordinating with ethics committees, negotiating contracts, and ensuring trial sites are fully prepared. This role requires strong knowledge of clinical research regulations, timelines, and collaboration with internal and external stakeholders. Effective study startup is crucial for minimizing delays and ensuring compliance with industry standards.
What are the key skills and qualifications needed to thrive in clinical study startup, and why are they important?
Success in a Clinical Study Startup role requires a strong understanding of clinical research processes, regulatory requirements, project management, and often a life sciences degree or related field. Familiarity with clinical trial management systems (CTMS), electronic trial master files (eTMF), and regulatory submission platforms is essential, along with certifications like GCP (Good Clinical Practice) being advantageous. Attention to detail, proactive problem-solving, and excellent organizational and communication skills help candidates excel. These qualifications ensure smooth study initiation, regulatory compliance, and effective cross-functional collaboration within demanding timelines.
What are the typical responsibilities of someone working in clinical study startup?
Professionals in Clinical Study Startup are primarily responsible for coordinating and executing study initiation activities, including regulatory document collection, ethics submissions, site contracting, and start-up logistics. They work closely with investigators, sponsors, and cross-functional teams to ensure all regulatory and site requirements are met before the clinical trial begins. This role often involves tight deadlines and frequent communication with stakeholders both internally and externally. It's a fast-paced position that is ideal for individuals who enjoy detail-oriented work and project coordination in a collaborative environment.

$100K - $140K/yr
Full-time
Posted 11 days ago
Job description
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.
We are seeking a highly motivated and detail-oriented Senior Clinical Study Manager (CSM) to join our Clinical Development team. In this role, you will lead the planning, execution, and management of both prospective and retrospective clinical evidence generation studies.
The ideal candidate thrives at the intersection of oncology, genomics, and data science. You will be responsible for ensuring that clinical studies are conducted with the highest quality standards, on time, and within budget, while leveraging Tempus's unique multimodal data platform.
Key Responsibilities
Study Leadership: Lead the end-to-end management of multiple clinical studies, including prospective observational trials and retrospective Real-World Evidence (RWE) studies.
Operational Planning: Develop study protocols, Informed Consent Forms (ICFs), Case Report Forms (CRFs), and study-specific manuals.
Vendor & Site Management: Oversee CROs, central labs, and clinical trial sites. Conduct site identification, feasibility assessments, and maintain strong relationships with Principal Investigators.
Data Integrity: Partner with Data Science and Bio-informatics teams to ensure high-quality data collection and clean datasets for retrospective analysis.
Compliance: Ensure all study activities adhere to ICH-GCP guidelines, HIPAA regulations, and internal Standard Operating Procedures (SOPs).
Cross-functional Collaboration: Work closely with Medical Affairs, Product, Legal, and Engineering teams to align study objectives with company milestones.
Timeline & Budget Tracking: Manage study milestones, identify potential risks to timelines, and implement mitigation strategies to keep projects on track.
Qualifications
Education: Bachelor's degree in a Life Sciences, Nursing, or related field (Advanced degree such as MS, MPH, or PhD preferred).
Experience: 5+ years of clinical trial management experience within a Biotech, Pharma, or CRO environment.
Domain Expertise: Strong understanding of oncology and/or molecular diagnostics. Experience with Real-World Data (RWD) or retrospective cohort studies is highly desirable.
Technical Skills: Proficiency with EDC systems, CTMS, and eTMF platforms. Familiarity with SQL or data visualization tools is a plus.
Soft Skills: Exceptional project management, communication, and problem-solving skills. Ability to work in a fast-paced, "startup" environment.
#LI-NK1
$100,000 - $140,000
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.