- 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
2 weeks 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 ...
-
Director Clinical Operations
3 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
3 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 ...
-
Valley Presbyterian Hospital California, United States Full time (72-80 Hours Per Pay Period)JOB SUMMARY: · The OR Registered Nurse is a licensed experienced professional supervised by the Nurse Manager/Nursing Director. An OR Registered Nurse is responsible for providing guidance, clinical expertise, and mentoring to members of the perioperative team within the special ...
-
Senior Director, Clinical Development Operations
1 month 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 ...
-
IT application administrator
2 weeks 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 ...
-
Director of Clinical Quality Assurance
2 weeks 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 ...
-
Manager, GCDO Business
3 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 ...
-
Entry level Clinical Trial Assistant
3 weeks ago
i-Pharm Consulting California, United StatesAs an Entry-Level CTA you will play a pivotal role in supporting our client's clinical trial operations. This is an excellent opportunity for individuals with a strong academic background and foundations knowledge in clinical trials to gain hands-on experience in a supportive and ...
-
Regional Clinical Director
2 weeks 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 ...
-
Systems Analyst
2 weeks 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 ...
-
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 ...
-
Senior Medical Director
2 weeks ago
GQR California, United StatesOur client is a Bay area cell therapy biotech developing therapeutics for autoimmune and inflammatory diseases. · Reporting to the CMO, the Medical Director will serve as the medical lead for CAR T-cell therapy clinical trials in multiple autoimmune disease indications, in partne ...
-
Senior Medical Director
2 weeks ago
Meet California, United StatesTitle: Senior Medical Director, Clinical Development · Description: The Senior Medical Director, Clinical Development is a vital contributor to the global clinical development programs at our growing exciting Oncology Biotech. This person is overseeing study-specific activities, ...
-
Meet California, United StatesJoin Our Innovative Medical Team: Senior Medical Director, Oncology · Are you ready to take your career to the next level? We are excited to invite you to become an integral part of our cutting-edge pharmaceutical company, a leader in discovering and developing groundbreaking tr ...
-
Clinical Sales Representative
2 weeks ago
Vapotherm California, United StatesPosition Title: Clinical Sales Associate · Reports to: Key Accounts Director · Department: Sales · The Clinical Sales Associate (CSA) position is a field-based position and responsible for maximizing the adoption of Vapotherm products, initiating & building sustainable relationsh ...
-
Aortic Stenosis Therapy Development Director
1 week ago
egnite Health California, United StatesJob Summary: · The Aortic Stenosis Therapy Development Director is seasoned in therapy development in healthcare with strong client-facing skills. This person will have experience driving initiatives to improve patient access to therapies. We are looking for a persuasive communic ...
-
Locum Physician
1 day ago
Barton Associates California, United States contractAnother locum tenens opportunity has arrived in California Our client, a multi-specialty clinic, is looking for a physician specializing in family practice to begin coverage in mid August. Hours include 8a - 5p shifts from Mondays - Fridays. The selected locum will be handling al ...
-
Penfield Search Partners Ltd California, United StatesAssociate Director/Senior Manager, Oncology Biostatistics · Location: Hybrid SF or PA · Contact: Susan Devine - · Our client is a clinical-stage biotech company with an established track record and a strong pipeline in Oncology and Rare Disease, looking for an experienced Biosta ...
-
Director of Nursing
3 weeks ago
SimiTree California, United StatesDirector of Nursing - Home Health · If you are an experienced Executive Director, Director of Operations, Administrator, Director of Nursing / DON, Director of Patient Care Services / DOPCS, or Director of Clinical Services / DOCS, Clinical Manager, Clinical Supervisor, or Pati ...
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:
