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Study Management Associate Jobs in San Ramon, CA

Personalis

Clinical Research Associate 2

Fremont, CA · On-site +1

$120K - $145K/yr

Clinical Research Associate 2 Fremont, CA Personalis, Inc. is a leader in advanced cancer genomics ... Manage Clinical study operations (internal and external) in coordination with CRO, IRB, regulatory ...

Personalis, Inc

Clinical Research Associate 2

Fremont, CA · On-site +1

$120K - $145K/yr

The Clinical Research Associate is responsible for managing clinical operations projects, which ... Manage Clinical study operations (internal and external) in coordination with CRO, IRB, regulatory ...

Personalis, Inc

Clinical Research Associate 2

Fremont, CA · On-site

$120K - $145K/yr

The Clinical Research Associate is responsible for managing clinical operations projects, which ... Manage Clinical study operations (internal and external) in coordination with CRO, IRB, regulatory ...

Braveheart Bio

Clinical Trial Manager

San Francisco, CA · On-site +1

$140K - $170K/yr

The primary responsibility of the CTM will be regional study management and vendor management. Key responsibilities: * With guidance from the Associate Director, ClinOps, responsibility for day-to ...

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Study Management Associate information

What are the key skills and qualifications needed to thrive as a Study Management Associate, and why are they important?

To thrive as a Study Management Associate, you need strong organizational skills, attention to detail, and a background in life sciences or clinical research, often supported by a relevant bachelor's degree. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) tools, and knowledge of regulatory guidelines such as GCP are typically required. Effective communication, time management, and problem-solving abilities help facilitate collaboration among cross-functional teams and ensure smooth study execution. These skills are crucial for maintaining the quality, compliance, and efficiency of clinical studies.

What are the typical responsibilities of a Study Management Associate in a clinical research team?

As a Study Management Associate, you will play a key role in supporting clinical trials by coordinating study logistics, maintaining essential documentation, and ensuring compliance with regulatory guidelines. Your daily tasks may include organizing meetings, tracking study progress, preparing reports, and liaising with clinical sites and vendors. You will work closely with study managers, clinical research associates, and data management teams to ensure trials run smoothly and efficiently. This collaborative environment provides valuable exposure to various aspects of clinical research and can serve as a strong foundation for career advancement within the industry.

What is a Study Management Associate?

A Study Management Associate is a professional who supports the planning, coordination, and execution of clinical trials or research studies. They typically assist study managers or project leads by handling administrative tasks, maintaining study documentation, and ensuring compliance with regulatory guidelines. Their responsibilities may include scheduling meetings, tracking study progress, managing study supplies, and liaising with study sites or vendors. This role is essential for keeping research studies organized and running efficiently.

What is the difference between Study Management Associate vs Clinical Research Coordinator?

AspectStudy Management AssociateClinical Research Coordinator
Required CredentialsBachelor's degree, relevant certifications often preferredBachelor's degree, often with certifications like CCRP
Work EnvironmentPharmaceutical companies, CROs, research institutionsHospitals, clinics, research sites
Employer & Industry UsageUsed in industry-sponsored trials and clinical research firmsCommon in academic and hospital-based studies
Search & Comparison IntentHigh overlap in job duties and qualificationsSimilar roles with some operational differences

The Study Management Associate and Clinical Research Coordinator roles share many similarities, including required education and work environments. However, the Study Management Associate typically focuses on supporting study operations within industry settings, while the Clinical Research Coordinator often manages patient interactions and site activities in clinical settings. Both roles are essential in advancing clinical research but differ slightly in scope and daily responsibilities.

What are popular job titles related to Study Management Associate jobs in San Ramon, CA? For Study Management Associate jobs in San Ramon, CA, the most frequently searched job titles are:
What job categories do people searching Study Management Associate jobs in San Ramon, CA look for? The top searched job categories for Study Management Associate jobs in San Ramon, CA are:
What cities near San Ramon, CA are hiring for Study Management Associate jobs? Cities near San Ramon, CA with the most Study Management Associate job openings:
Study Management Associate jobs near you
Sr. Clinical Trial Associate

Sr. Clinical Trial Associate

ALX Oncology Inc.

South San Francisco, CA • On-site

$100K - $120K/yr

Full-time

Posted 22 days ago

Job description

POSITION SUMMARY:
A Clinical Trial Associate (CTA) supports clinical operations by supporting and progressively owning key study execution activities including startup,Trial Master Files (TMF) management, tracking study documents, assisting with site activation, and managing trial reports and supplies.
They ensure compliance with ICH/GCP regulations and internal SOPs while proactively identifying gaps, escalating risks, and supporting inspection readiness.
Additional responsibilities include study coordination, vendor communication, and data tracking.
Study Documentation:
  • Maintain electronic Trial Master Files (eTMF) and ensure documents comply with regulatory requirements
  • Perform ongoing TMF quality review and support inspection readiness, including identification and resolution of document gaps
  • Partner with CROs and internal teams to ensure timely filing and reconciliation of essential documents
  • Support TMF audits and health checks

Additional Responsibilities
  • Support Clinical Trial Manager (CTM), Study lead and Study Management Team (SMT) in study start up and executional activities
  • Site Support: Support site activation, ethical submissions, and track site-level documents (e.g., informed consent forms). Assist in coordination of site onboarding and ensure completeness of site essential documentation
  • Vendor/Supply Management: Track and ship study-related materials and investigational products (IP). Support oversight of CRO and vendor deliverables, ensuring timelines and documentation expectations are met. Identify potential risks and proactively resolve issues with vendors. Assist in review of vendor management and other study plans. Tracking and requesting site access from vendors.
  • Study Tracking: Update trackers for enrollment, site monitoring, and data queries. Support maintenance of CTMS and study level tracking tools to ensure data accuracy and alignment across systems. Identify and communicate risks to study timelines or deliverables. Compile study and quality metrics for team review.
  • Team Communication: Act as a point of contact for clinical sites, vendors, and internal team members. Collaborate cross functionally with Clinical Operations, Data Management, Regulatory, and Safety teams.
  • Meetings: Coordinate and take minutes for project team meetings and investigator meetings. Track action items and follow up to ensure completion
  • Collaborate with relevant team members in coordination and tracking of vendor and investigator site budgets, contracts, invoices, and/or payments as needed.
  • Additional tasks as assigned

CORE COMPETENCIES:
  • Understanding of the drug development process.
  • Ability to work within a team, yet work independently and display good judgement as to when to escalate issues and check in
  • Strong verbal and written communication.
  • Problem-solving and adaptability to shifting priorities
  • Ability to operate effectively in a fast paced, evolving startup environment
  • Strong prioritization and time management skills under competing demands
  • Collaborative mindset with ability to influence without direct authority

QUALIFICATIONS AND SKILLS:
  • Education: Four-year degree, focus in a related field preferred but not required
  • Experience: 1-3 years in clinical research (CRO or sponsor environment). Experience supporting multiple clinical trials, preferably in oncology or complex therapeutic areas. Small/startup biotech environment a big plus.
  • Knowledge: Working knowledge of ICH-GCP regulations. Understanding of clinical trial lifecycle, including startup, maintenance, and closeout activities
  • Technical Skills: Proficiency in MS Office Suite (Excel, Word, PowerPoint) and eTMF/EDC systems (e.g., Veeva Vault). Familiarity with CTMS and document reconciliation processes preferred
  • Attributes: Strong organizational skills, attention to detail, and ability to manage multiple tasks. Ability to work independently, exercise judgment, and escalate issues appropriately

WORK ENVIRONMENT AND ENVIRONMENTAL CONDITIONS:
We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.
ALX Oncology is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law.
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
ABOUT ALX ONCOLOGY
ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, Evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. Our second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and potential to be both first and best in class.
For more information about us, please visit www.alxoncology.com.

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