- Overseeing clinical trial operations and ensuring compliance with GCP guidelines.
- Collaborate with and direct Contract Research Organizations, managing study execution and document development.
- Oversee data review processes, supervise Clinical Research Associates, and support audits of sites and vendors, ensuring efficient trial management.
- Lead and supervise all clinical operations, ensuring adherence to GCP guidelines and regulatory compliance.
- Utilize robust organizational skills and medical writing expertise to manage complex trial activities, including the creation of clear and comprehensive clinical documents
- Utilize project management methodologies to effectively oversee trial execution, ensuring consistent engagement with Contract Research Organizations (CROs) for timely and accurate completion of trial milestones
- Negotiate contracts and manage relationships with vendors and service providers, while partnering with study sites to ensure efficient and professional conduct
- Manage budget negotiations and control expenses to keep trials within financial constraints
- Oversee the site selection process and develop essential study documents and tools, such as protocols, consent forms, project plans, and budgets
- Participate in the creation and refinement of Clinical Operations SOPs and training materials
- Implement and maintain the Trial Master File for inspection readiness and conduct training sessions for study teams
- Provide updates to senior leadership and proactively manage project risks, recommending innovative processes to enhance trial management
- Oversee data integrity through reviews and cleaning activities, and ensure Clinical Research Associates effectively manage site operations
- Support compliance and quality through audits of sites and vendors, manage study supplies, and collaborate with other departments for resource alignment
- Bachelor's or Master's degree in a relevant scientific field
- Minimum of 10 years of clinical trial experience, including clinical trial management and clinical monitoring in pharmaceutical, biotech, or CRO setting: siRNA study experience preferred
- ICH/GCP Training
- Thorough knowledge of drug development, clinical operation processes, and procedures according to ICH/GCP and other regulatory guidelines
- Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint
- Proven ability to manage multiple projects simultaneously in a changing environment
- Proven ability to collaborate effectively with internal teams and external collaborators
- Self-motivated, comfortable working in a start-up environment where everyone contributes to achieving company goals, flexible, and innovative
- Experience managing Phase I - III trials, knowledge of clinical operations, ICH/GCP, and regulatory requirements
-
Head of Clinical Operations
1 week ago
Persimmon California, United StatesThe Role · Location: Larkspur, CA or remote · About Us: · is a venture capital funded startup building a national brand in the medical aesthetics / healthcare industry. Our unique business model allows customers to book a nurse to visit the customers' home to provide beauty treat ...
-
Clinical Operations Specialist
2 weeks ago
The Stepping Stones Group California, United States Full timeClinical Operations Implementation Specialist · The Stepping Stones Group is transforming the lives of children, families, and communities together through our exceptional therapeutic and behavioral health services. We believe our Core Values embody the culture of our organizati ...
-
Clinical Operations Manager
4 weeks ago
BioPhase California, United StatesCandidates must be located in the United States · Reporting to the Associate Director of Clinical Operations, the Clinical Trials Manager will be accountable for managing the clinical operation activities for clinical studies. This person will be key in driving the clinical studi ...
-
Director Clinical Operations
2 weeks ago
EPM Scientific California, United StatesDirector, Clinical Operations · $215,000-$240,000 · The biotechnology company is at the forefront of groundbreaking research in the field of Immuno-Oncology. They harness the power of the immune system to fight cancer, firmly establishing themselves as pioneers in this rapidly ev ...
-
Clinical Operations Specialist, LPN
3 weeks ago
K Health California, United StatesWho we are: · K Health is venture-backed, fast-growing startup with a mission to use the power of Artificial Intelligence (AI) to get everyone access to higher quality healthcare at more affordable costs. We're looking for mission driven individuals to join our team and help us e ...
-
Senior Director, Clinical Development Operations
3 weeks ago
AbbVie California, United States Full time· Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic ar ...
-
Speech Therapy Team Leader
1 week ago
Nexus Solutions Republic, United StatesASKLEPIOS As one of the largest private hospital operators in Germany, we see ourselves as companions to our patients - and as partners to our employees. We bring together what belongs together: closeness and progress, warmth and high standards, teamwork and appreciation, people ...
-
IT application administrator
1 week ago
Apex Ventures Superior, United StatesJoin our IT team at Superior 'Katharina Kasper Gruppe GmbH as an IT application support specialist / application manager (m/f/d) in full-time at our locations in Dernbach (Westerwald), Düsseldorf, Wesseling or Zell (Mosel). Together, let's shape the future of IT. · Your responsib ...
-
Clinical Trial Manager
2 weeks ago
Bayside Solutions California, United StatesClinical Trial Manager / Senior Clinical Trial Manager · W2 Contract-to-Hire · Salary Range: $156,000 - $187,200 per year · Location: Redwood City, CA - Hybrid or Remote PST · Job Summary: · As the Clinical Program Manager of Clinical Operations, you will be responsible for Contr ...
-
Regional Clinical Director
6 days ago
LaserAway California, United StatesJob Title: Regional Clinical Director - RN/NP · Location: San Francisco, CA · Department: Clinical · Reports to: Sr. Vice President of Clinical Operations · Pay: k DOE · Job Summary: · The Regional Clinical Director at LaserAway plays a vital role in ensuring the delivery of exce ...
-
Nuclear Medicine Technologist
5 days ago
PSG , CA, United StatesThe Opportunity · Description · We're looking for a Nuclear Medicine Technologist - Permanent + Relocation Bonus, working in the Healthcare Systems & Services industry in California, United States. · Job Summary · This role is located in Simpsonville and Seneca, South Carolina · ...
-
Clinical Systems Administrator
3 weeks ago
Medix Technology California, United StatesJob Title: Clinical Systems Administrator · Work Location: Primarily Remote - Los Angeles Metro Area* · Position Type: Direct HIre · Compensation: $120,000 - $125,000 / year, depending on experience + full time benefits · ABOUT OUR CLIENT / ABOUT THE ROLE · Medix is currently s ...
-
Director of Clinical Quality Assurance
6 days ago
GQR California, United StatesTitle: Director of Clinical Quality Assurance · Location: San Francisco, CA · Hybrid role, 2 days a week onsite · Status: Full-time direct hire · This position is a hands-on role tasked with ensuring that sponsored clinical trials comply with applicable GCP regulations (e.g., FDA ...
-
Regional Clinical Director
6 days ago
Novaris Search California, United StatesNovaris Search are working with a growth minded Autism Healthcare provider that specialise in ABA services. They are actively seeking a Regional Clinical Director to join the company and support the team, whilst ensuring good compliance and efficient clinical oversight. · As Reg ...
-
Manager, GCDO Business
2 weeks ago
Jazz Pharmaceuticals California, United States Full timeBrief Description: · The Manager, GCDO Business & Technology Capabilities demonstrates broad knowledge of the Clinical Development process and the technologies, systems, and applications that support this. The role is responsible for the design, development, production, delivery ...
-
Associate Director, Clinical Supply Chain
4 weeks ago
Life Science People California, United StatesAn innovative precision oncology company, is hiring a leader to spearhead our clinical programs. Join us in revolutionizing cancer treatment · Responsibilities: · Lead clinical demand and supply plans · Manage supply logistics and activities · Collaborate with cross-functional te ...
-
Systems Analyst
1 week ago
Medix Technology California, United StatesJob Title: Systems Analyst - Ancillary Applications · Work Location: Primarily Remote w/ occasional onsite in Los Angeles · *Talent must reside < 150 miles from the Los Angeles Metro Area · Position Type: Direct HIre · Compensation: $100,000 - $125,000 / year, depending on expe ...
-
PET/CT Nuclear Medicine Technologist
2 days ago
Siemens Healthineers , CA, United StatesThe Opportunity · Description · We're looking for a PET/CT Nuclear Medicine Technologist - Permanent + Relocation Bonus, working in the Healthcare Systems & Services industry in California, United States. · Job Summary · This role is located in Greenville, South Carolina · Under ...
-
Sr Medical Director/Medical Director
4 weeks ago
Meet California, United StatesMeet has partnered with a biotech that is at the forefront of research and development in cortisol modulation, pioneering molecules that regulate cortisol activity at the glucocorticoid receptor (GR). They are seeking a Sr Medical Director/Medical Director to play a pivotal role ...
-
Jazz Pharmaceuticals California, United States Full timeBrief Description: · The Associate Director, Clinical Data Innovation is responsible for overseeing all personnel, processes, and technologies that comprise the data and analytics platforms used by the Jazz Global Clinical Development Operations (GCDO) department. The two platfo ...
Director Clinical Operations - California, United States - BioPhase
Description
Hybrid Position | Located in San Diego, CA
This Director of Clinical Operations will play a pivotal role in leading and supervising all activities related to clinical operations, including the management and execution of clinical trials in accordance with Good Clinical Practices (GCP) as well as in compliance with various governing regulatory agencies. This role involves overseeing participating study sites, managing vendors, ensuring compliance with regulatory guidelines, and implementing innovative processes to improve clinical trial management and deliverables.
Responsibilities:
Education/Skill:
