Senior Clinical Trial Specialist
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
JOB TITLE: Senior Clinical Trial Specialist
DEPARTMENT: Clinical Operations
HIRING MANAGER: Lorna Dean
LOCATION: South San Francisco, California / Remote (Hybrid)
TYPE: Full-Time
HI-Bio is a clinical-stage biotechnology company based in South San Francisco, California. Our shared purpose is to transform the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. We have a precision medicine approach grounded in emerging human genetics. HI-Bio's team is made up of industry experts from science and technology. We are on a path to building the leading immunology company. To accomplish this, we are seeking top talent to join us on our journey.
We are seeking a Senior Clinical Trial Specialist to assist in the execution of Clinical Trials. The successful candidate will be able to support the conduct of clinical trials with minimal guidance/supervision while ensuring alignment with GCP and HI-Bio’s SOPs. The Specialist provides a high level of administration, coordination and organizational support to the Clinical Study Lead and team members from all functions involved in assigned study(ies). The role requires an ability to manage multiple priorities consecutively and priorities consecutively and sequentially and meeting quality standards for accuracy, attention to detail and timelines. As part of a growing clinical development operations team, the Specialist will help define various aspects of clinical trials to ensure timely completion, efficient protocols, budget alignment, and compliance with ICH/GCP Guidelines.
The role reports to the Senior Vice President, Development operations. Level will be commensurate with experience.
KEY RESPONSIBILITIES:
- Overall global tracking of study deliverables with escalation of key issues/trends.
- Support and/or manage protocol related site/supplier activities.
- Assist and/or manage in the design, format, review and content of study guides, worksheets, quick reference cards and other materials/documents used to support the study.
- Contribute to protocol review and amendment management, including informed consent initiation and updates.
- Attend, contribute and potentially lead supplier meetings; work with suppliers to resolve issues, and foster process improvements.
- Monitor progress of studies, help identify study related trends/issues and work with Clinical Trial Managers (CTM) to implement corrective actions when necessary.
- Submission of documents to TMF and assist with TMF reconciliation as needed.
- Oversee study start-up activity tracking with CTM oversight.
- Assist with maintaining FAQ and ADI logs; manage resolution of actions.
- May assist with the quality control of clinical data for CSR preparation.
- Assist CTM with meeting agenda and maintain minutes for internal /external team meetings.
- Assist tracking study milestones in tools and dashboards.
- Point of contact (as delegated) for study related issues.
- May participate in data review (e.g., line listings).
- Contribute to the development of recruitment strategies and materials; assist with external recruitment activities and supplier management.
- Work with sample management to coordinate shipment and analysis of sample needs; lead reconciliation efforts.
- Track study level investigational product accountability and reconciliation for studies and at close-out with depots; align with CMC to determine supply needs.
- Manage temperature excursion process flow.
- Help coordinate investigator meetings, study related workshops, and other meetings as applicable.
- May provide clinical site support (e.g., materials to site/CRAs).
- Support and contribute to Inspection Readiness processes.
- May participate in cross-functional study management activities and process improvement initiatives.
- Postings to clinical trial websites.
- Lead Site Management Oversight tasks to ensure CRO activities are being completed per the Monitoring Plan
- May conduct monitoring/co-monitoring visits with CRO or CTM.
- Participate in User Acceptance Testing (UAT) with supplier systems.
- Contribute to protocol review, content and ICF development.
- Overall collaboration with process development and implementation.
- Some travel may be required (
-
Senior Clinical Trial Specialist
1 week ago
South San Francisco, United States HI-Bio Full timeJOB TITLE: Senior Clinical Trial SpecialistDEPARTMENT: Clinical OperationsHIRING MANAGER: Lorna DeanLOCATION: South San Francisco, California / Remote (Hybrid)TYPE: Full-TimeHI-Bio is a clinical-stage biotechnology company based in South San Francisco, California. Our shared purpose is to transform the lives of patients with severe immune-mediated diseases...
-
Senior Clinical Trial Specialist
3 days ago
South San Francisco, United States HI-Bio Full timeJOB TITLE: Senior Clinical Trial Specialist DEPARTMENT: Clinical Operations HIRING MANAGER: Lorna Dean LOCATION: South San Francisco, California / Remote (Hybrid) TYPE: Full-Time HI-Bio is a clinical-stage biotechnology company based in South San Francisco, California. Our shared purpose is to transform the lives of patients with severe immune-mediated...
-
Senior Clinical Trial Associate
Found in: beBee jobs US - 1 week ago
South San Francisco, California, United States Alumis Inc. Full timeAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients.As a Sr. CTA, you will work closely with the...
-
Senior Clinical Trial Associate
Found in: beBee S US - 2 weeks ago
South San Francisco, United States Alumis Inc. Full timeAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients. As a Sr. CTA, you will work closely with the...
-
Senior Clinical Trial Associate
7 days ago
South San Francisco, United States Alumis Full timeJob DescriptionJob DescriptionSalary: Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients.As a Sr....
-
Senior Clinical Trial Associate
1 week ago
South San Francisco, United States Alumis Full timeJob DescriptionJob DescriptionSalary: Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients.As a Sr....
-
South San Francisco, United States CareerBuilder Full timeClinical Trial Associate, Clinical Operations Posted: 01/29/2024 Employment Type: Direct Hire Job Category: Operations and Development Job Number: 3734 Job Description Reporting to the Director of Clinical Operations, this role is responsible for collaborating with and utilizing instructions/ information from study managers or global project leaders to...
-
Senior Clinical Trial Manager
Found in: beBee S US - 1 week ago
South San Francisco, United States EPM Scientific Full timeSouth San Francisco, CA - Hybrid (3 days per week on-site)This oncology-focused biotech company is located in South SF and is at the forefront of drug development within their specific therapeutic area.Due to being one of the most cutting-edge leaders in this space, the company recently raised over $100M in their latest round of funding.They are currently...
-
Senior Clinical Trial Manager
Found in: beBee jobs US - 2 weeks ago
South San Francisco, California, United States EPM Scientific Full timeSouth San Francisco, CA - Hybrid (3 days per week on-site)This oncology-focused biotech company is located in South SF and is at the forefront of drug development within their specific therapeutic area.Due to being one of the most cutting-edge leaders in this space, the company recently raised over $100M in their latest round of funding.They are currently...
-
South San Francisco, United States The Steely Group Full timeSr. Clinical Trial Associate, Clinical Operations Posted: 01/29/2024 Employment Type: Direct Hire Job Category: Operations and Development Job Number: 3735 Job Description Reporting to the Director of Clinical Operations, this role is responsible for collaborating with and utilizing instructions/information from study managers or global project leaders to...
-
Temporary - Clinical Trial Associate
1 week ago
South San Francisco, United States Structure Therapeutics Full timeJob DescriptionJob DescriptionSalary: Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally...
-
Clinical Trial Manager
1 week ago
San Francisco, United States EPM Scientific Full timeSalary: $140-165K Company Summary: A global, specialty pharmaceutical group with an impressive track record is seeking a motivated Clinical Trial Manager for a hybrid role at their San Francisco site. Their commercial supply of pharmaceutical products generated $83m in revenue in FY2023 (a 24% uptick from the year prior). Since their first clinical trials in...
-
Clinical Trial Site Manager
5 days ago
San Francisco, United States CareerBuilder Full timeClinical Trials Site Manager, you will be an essential member of our clinical team. You will lead the study team and be responsible for the execution of complex clinical trials from study design through study close out. You will be responsible for business and financial management of our research site as well as oversight of day-to-day operations. Education:...
-
Clinical Trial Site Manager
2 days ago
San Francisco, United States Pharma Search Partners Full timeClinical Trials Site Manager, you will be an essential member of our clinical team. You will lead the study team and be responsible for the execution of complex clinical trials from study design through study close out. You will be responsible for business and financial management of our research site as well as oversight of day-to-day operations. Education:...
-
Structural Heart Industry Expert
7 days ago
San Francisco, United States Medsurg Sales Staffing Full timeJob DescriptionJob DescriptionAre you looking for a unique and exciting opportunity to join a growing division at a blue chip medical device manufacturer? We are currently seeking a "Clinical Specialist" to join our team and help spearhead clinical trials for a revolutionary new product in the structural heart arena. This product promises to revolutionize...
-
Structural Heart Industry Expert
1 week ago
San Francisco, United States Medsurg Sales Staffing Full timeJob DescriptionJob DescriptionAre you looking for a unique and exciting opportunity to join a growing division at a blue chip medical device manufacturer? We are currently seeking a "Clinical Specialist" to join our team and help spearhead clinical trials for a revolutionary new product in the structural heart arena. This product promises to revolutionize...
-
Structural Heart Industry Expert
12 minutes ago
San Francisco, United States Medsurg Sales Staffing Full timeJob DescriptionJob DescriptionAre you looking for a unique and exciting opportunity to join a growing division at a blue chip medical device manufacturer? We are currently seeking a "Clinical Specialist" to join our team and help spearhead clinical trials for a revolutionary new product in the structural heart arena. This product promises to revolutionize...
-
Trialing Specialist 3
Found in: Resume Library US A2 - 1 week ago
Yankton, South Dakota, United States Syngenta Seeds Full timeJob Description At Syngenta, we believe every employee has a role to play in safely feeding the world and taking care of our planet. To support that challenge, the Seeds Development Team is currently seeking a Independent Trialing Specialist, to be located in Northeast, NE. Role Purpose This role will provide the highest quality field trial data through...
-
Senior Clinical Research Associate
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
South San Francisco, United States Astrix Full timeOur client is a renowned biotech company that specializes in medicinal biology and chemistry creating products across all phases of clinical trials and they are looking to add a Senior Research Associate to their hard-working team! Located in South San Francisco, CAType of job: 6 month contractOnsite Pay: $45-53/hourResponsibilities:This role will undertake...
-
Senior Clinical Research Associate
Found in: Appcast US C2 - 1 week ago
South San Francisco, United States Astrix Full timeOur client is a renowned biotech company that specializes in medicinal biology and chemistry creating products across all phases of clinical trials and they are looking to add a Senior Research Associate to their hard-working team! Located in South San Francisco, CAType of job: 6 month contractOnsite Pay: $45-53/hourResponsibilities:This role will undertake...
