Clinical Trial Manager
2 weeks ago
The Clinical Trial Manager holds responsibility for overseeing the implementation of ongoing clinical trials, ensuring compliance with relevant quality standards such as ICH-GCP Guidelines, SOPs, and applicable regulations.
Key Roles and Responsibilities:
- Lead the overall execution of one or more clinical trials, including oversight of setup, ongoing quality assessment, and final reconciliation of study documents.
- Review site regulatory documents/packages for Sponsor oversight of CRO and site activities.
- Ensure collection, inventorying, and filing of study regulatory files align with ICH GCP and sponsor requirements.
- Assist in preparing and following up on in-house and on-site quality audits, as well as regulatory authority inspections.
- Develop specifications for outsourcing to vendors, reviewing vendor proposals, contracts, and budgets for accuracy.
- Oversee clinical monitoring and other vendor activities to ensure integrity, accuracy, and accountability of trial activities and data.
- Coordinate with CRO and data management for database cleaning and final database lock.
- Collaborate with the CMC team regarding investigational product supply and any on-site IP issues during the trial.
- Partner with consultants for review and advice on clinical and laboratory matters.
- Contribute to the development of abstracts, presentations, manuscripts, and other external communication materials.
- Perform other assigned activities as required.
Preferred Education/Experience:
- Bachelor of Science degree or equivalent, preferably in Life Sciences.
- Minimum of 6 (7 years for Senior CTM) years of clinical trial experience, with at least 1-2 years managing clinical trial activities.
- Senior CTM requires experience managing a CRO and a complex study in a previous Clinical Trial Manager or Clinical Project/Program Manager position.
- Experience in set-up and management of third-party vendors, as well as study start-ups.
- Experience with phases I & II clinical trials; phase III & global trial experience are advantageous.
Knowledge, Skills, and Abilities:
- Strong knowledge of FDA, CFR, and ICH GCP requirements, along with other regulatory standards.
- Excellent leadership and management skills to provide planning, coordination, and direction.
- Outcome-driven with the ability to thrive in a fast-paced environment and effectively manage pressure.
- Proficiency in setting up and tracking key metrics and motivating a study team.
- Proven interpersonal skills with the ability to build strong relationships cross-functionally.
- Proficiency with MS Office products and electronic systems.
- Flexibility in work hours to accommodate international collaborations and travel requirements.
-
Associate Director, Clinical Data Management
7 days ago
Bothell, United States Medix Full timeThe Associate Director of Clinical Data Management will take the lead in managing data for multiple clinical studies and/or a clinical development program. Reporting to the Senior Director of Clinical Operations, the individual in this role will offer guidance and leadership across all stages of clinical studies, from EDC study design to study closeout. They...
-
Associate Director, Clinical Data Management
6 days ago
Bothell, United States Medix Full timeThe Associate Director of Clinical Data Management will take the lead in managing data for multiple clinical studies and/or a clinical development program. Reporting to the Senior Director of Clinical Operations, the individual in this role will offer guidance and leadership across all stages of clinical studies, from EDC study design to study closeout. They...
-
Quality Control Specialist- Flow Cytometry
3 weeks ago
Bothell, United States TD2 Full timeJob DescriptionJob DescriptionWe are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide our client's...
-
Quality Control Specialist- Flow Cytometry
2 days ago
Bothell, United States TD2 Full timeJob DescriptionJob DescriptionWe are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide our client's...
-
Senior Director, Clinical Pharmacology and Pharmacometrics
Found in: Jooble US O C2 - 6 days ago
Bothell, WA, United States Immunome Inc Full timeJob Title: Senior Director, Clinical Pharmacology and Pharmacometrics Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including immunotherapies, targeted effectors, radioligand therapies and antibody drug...
-
Bothell, United States Molina Healthcare Full timeJob DescriptionJOB DESCRIPTIONJob SummaryMolina Healthcare Services (HCS) works with members, providers and multidisciplinary team members to assess, facilitate, plan and coordinate an integrated delivery of care across the continuum, including behavioral health and long term care, for members with high need potential. HCS staff work to ensure that patients...
-
Bothell, United States Molina Healthcare Full timeJob DescriptionJOB DESCRIPTIONJob SummaryMolina Healthcare Services (HCS) works with members, providers and multidisciplinary team members to assess, facilitate, plan and coordinate an integrated delivery of care across the continuum, including behavioral health and long term care, for members with high need potential. HCS staff work to ensure that patients...
-
Quality Assurance
2 days ago
Bothell, United States Spectraforce Technologies Full timeTitle: Quality Assurance Specialist (Pharma ONLY - NON IT JOB) Duration: 06 Months Location: Bothell, WA *Schedule- 9:00pm - 7:30am, Sun - Wed** **Top Skills: - 3-5 years of GMP work experience - Familiarity with Batch Records - Deviations Experience Preferred - Associates or BA Degree preferred, or HS Diploma + relevant work experience - Soft...
-
Quality Assurance
Found in: Appcast US C2 - 3 days ago
Bothell, United States Spectraforce Technologies Inc Full timeTitle: Quality Assurance Specialist (Pharma ONLY - NON IT JOB) Duration: 06 Months Location: Bothell, WA *Schedule- 9:00pm - 7:30am, Sun - Wed** **Top Skills: - 3-5 years of GMP work experience - Familiarity with Batch Records - Deviations Experience Preferred - Associates or BA Degree preferred, or HS Diploma + relevant work experience -...
-
Chiropractor - Bothell, WA
Found in: Lensa US P 2 C2 - 2 weeks ago
Bothell, United States The Joint Chiropractic Full timeLooking for a new way of delivering quality chiropractic care? The right adjustment is all it takes. Here at The Joint Chiropractic, we’ve got your back. As one of our doctors, you will find that our unique operating model gives you all the support you need to focus on doing what you do best: looking after your patients. We support you with marketing,...
-
Treatment Coordinator
1 week ago
Bothell, United States Gentle Dental Full timeAt Gentle Dental, we value our teammate’s smile as much as our patient’s smile. Our vision is to provide exceptional, lifelong, integrated oral healthcare services. We enhance the quality of our patients’ lives by providing accessible oral healthcare, which is paramount to overall health and wellbeing. We focus on a commitment to patient care,...
-
Treatment Coordinator, Ortho
2 weeks ago
Bothell, United States Gentle Dental Full timeAt Gentle Dental, we value our teammate’s smile as much as our patient’s smile. Our vision is to provide exceptional, lifelong, integrated oral healthcare services. We enhance the quality of our patients’ lives by providing accessible oral healthcare, which is paramount to overall health and wellbeing. We focus on a commitment to patient care,...
-
Treatment Coordinator
7 days ago
Bothell, United States Gentle Dental Full timeAt Gentle Dental, we value our teammate’s smile as much as our patient’s smile. Our vision is to provide exceptional, lifelong, integrated oral healthcare services. We enhance the quality of our patients’ lives by providing accessible oral healthcare, which is paramount to overall health and wellbeing. We focus on a commitment to patient care,...
-
QUALITY CONTROL SPECIALIST- FLOW CYTOMETRY
Found in: Careerbuilder One Red US C2 - 3 days ago
Bothell, WA 98021, USA, United States TD2 Full timeWe are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology - it is all we do - combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking - we guide our client's therapy through the most critical...
-
QA Shop Floor Specialist
2 days ago
Bothell, United States Sunrise System Inc Full timeJob Description: Schedule- 9:00pm - 7:30am, Sun - Wed Top Skills: 3-5 years of GMP work experience Familiarity with Batch Records Deviations Experience Preferred Associates or BA Degree preferred, or HS Diploma + relevant work experience Soft skills include- strong cross-functional experience, strong interpersonal skills Job Description: ...
-
QA Shop Floor Specialist
1 day ago
Bothell, United States Sunrise System Inc Full timeSchedule- 9:00pm - 7:30am, Sun - Wed Top Skills: 3-5 years of GMP work experience Familiarity with Batch Records Deviations Experience Preferred Associates or BA Degree preferred, or HS Diploma + relevant work experience Soft skills include- strong cross-functional experience, strong interpersonal skills Job Description: The Quality...
-
QA Shop Floor Specialist
Found in: Appcast US C2 - 3 days ago
Bothell, United States Sunrise System inc Full timeJob Description: **Schedule- 9:00pm - 7:30am, Sun - Wed** **Top Skills: 3-5 years of GMP work experience Familiarity with Batch Records Deviations Experience Preferred Associates or BA Degree preferred, or HS Diploma + relevant work experience Soft skills include- strong cross-functional experience, strong interpersonal skills ...
-
QA Shop Floor Specialist
Found in: Appcast US C2 - 2 days ago
Bothell, United States Sunrise System inc Full time**Schedule- 9:00pm - 7:30am, Sun - Wed** **Top Skills: 3-5 years of GMP work experience Familiarity with Batch Records Deviations Experience Preferred Associates or BA Degree preferred, or HS Diploma + relevant work experience Soft skills include- strong cross-functional experience, strong interpersonal skills *Job...
-
Cell Culture Laboratory Associate
1 week ago
Bothell, United States CareerBuilder Full timePassionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical...
-
Quality - QA Shop Floor Specialist
1 hour ago
Bothell, United States HonorVet Technologies Full timeJob Description: **Schedule- 9:00pm - 7:30am, Sun - Wed** **Top Skills: - 3-5 years of GMP work experience - Familiarity with Batch Records - Deviations Experience Preferred - Associates or BA Degree preferred, or HS Diploma + relevant work experience - Soft skills include- strong cross-functional experience, strong interpersonal skills *Job Description: The...