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Study Management Associate Jobs in San Ramon, CA

Intuitive

Senior Clinical Study Manager

Sunnyvale, CA · On-site

The candidate will be required to work closely with clinical research associates (CRAs), clinical trial assistants (CTAs) and data management for the conduct and execution of the study, as well as ...

Intuitive

Senior Clinical Study Manager

Sunnyvale, CA · On-site +1

The candidate will be required to work closely with clinical research associates (CRAs), clinical trial assistants (CTAs) and data management for the conduct and execution of the study, as well as ...

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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
Associate Director, Clinical Study Management

Associate Director, Clinical Study Management

Eikon Therapeutics

Millbrae, CA • On-site

$183K - $199.50K/yr

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 17 days ago

Job description

Position

The Associate Director, Clinical Study Management, will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world class inhouse clinical study management.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

You are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology.

What You'll Do

  • Team leader and builder, who manages clinical trial deliverables, timelines, and budgets per the Clinical Development and Operational Plans
  • Works with minimal oversight from the Clinical Operations Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development functional teams
  • Demonstrate broad understanding of therapeutic and clinical drug development expertise to influence study design and program-level decisions 
  • Provide direction to cross-functional study teams to ensure successful study execution Ensure that clinical studies are conducted  following approved protocols, FDA Regulations, ICH-GCP, EMA, PMDA, other relevant regulations, directives, and guidelines, and company procedures and quality documents
  • Oversee risk identification, assessment, and mitigation strategies to ensure patient safety and data integrity
  • Responsible for the implementation of processes and systems that will facilitate inspection readiness throughout the lifecycle of the trial.
  • Oversee the preparation and maintenance of detailed clinical trial project timelines
  • Manage ancillary (non CRO) vendor relationships and performance to ensure that clinical studies are completed following contract specifications of time, cost and quality.
  • Work with finance, legal, and external vendors to ensure the assigned studies are meeting the target milestones
  • Provide regular updates on study progress to stakeholders (e.g., Clinical Operations, Project & Portfolio Management, Clinical Research)
  • Ensure that all study-related documents are accurate, complete, timely and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems.
  • Responsible for hiring, performance management, career development, and providing mentorship to Clinical Study Management personnel.
  • Contribute to initiatives and projects adding value to Eikon Therapeutics

Qualifications

  • Minimum of 10 years of related experience with a Bachelor's degree or 8 years and a post-graduate degree.
  • Experience leading large, global clinical trials, preferably in oncology
  • In-depth knowledge of ICH-GCP, EMA guidelines and other relevant regulations and guidelines.
  • Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety.
  • Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams.
  • Experience with management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery.
  • High sense of accountability and urgency to prioritize deliverables.
  • Growth mindset and capable of working independently.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:

  • 401k plan with company matching
  • Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
  • Mental health and wellness benefits
  • Weeklong summer and winter holiday shutdowns
  • Generous paid time off and holiday policies
  • Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
  • Enhanced parental leave benefit
  • Daily subsidized lunch program when on-site

The expected salary range for this role is $183,000 to $199,500 depending on skills, competency, and the market demand for your expertise.

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