The Clinical Affairs Senior Manager/Associate Director will be responsible for the design ... Study Design, Execution, and Oversight * Oversee the design, initiation, execution, monitoring, and ...
The Clinical Affairs Senior Manager/Associate Director will be responsible for the design ... Study Design, Execution, and Oversight * Oversee the design, initiation, execution, monitoring, and ...
Senior Clinical Trials Management Associate
$115K - $149K/yr
Prepares and/or reviews study-related or essential study start-up documents as they relate to the supported clinical trials as delegated by the study manager (e.g., Clinical protocols, Informed ...
Senior Clinical Trials Management Associate
$115K - $149K/yr
Prepares and/or reviews study-related or essential study start-up documents as they relate to the supported clinical trials as delegated by the study manager (e.g., Clinical protocols, Informed ...
Oversees aspects of study management and vendors to ensure high quality of data * Providing Clinical Research Associates with project-specific training, guidance, and oversight, assigning ...
Oversees aspects of study management and vendors to ensure high quality of data * Providing Clinical Research Associates with project-specific training, guidance, and oversight, assigning ...
Senior Clinical Trial Manager (Sr CTM)
Redwood City, CA · On-site
$170K - $200K/yr
This position may also independently manage operational aspects of clinical study. This leader will work with cross-functional teams as well as vendors, clinical sites, and CROs to execute protocol ...
Senior Clinical Trial Manager (Sr CTM)
Redwood City, CA · On-site
$170K - $200K/yr
This position may also independently manage operational aspects of clinical study. This leader will work with cross-functional teams as well as vendors, clinical sites, and CROs to execute protocol ...
As a Clinical Program Manager (CPM), you will be responsible for acting as a central contact for the Clinical Study Team(s) and assist with the execution and management of Revolution Medicines ...
As a Clinical Program Manager (CPM), you will be responsible for acting as a central contact for the Clinical Study Team(s) and assist with the execution and management of Revolution Medicines ...
We are seeking a highly strategic Clinical Study Operations Engineering Program Manager to provide flexible oversight across our study portfolio. Acting as a critical bridge between recruitment ...
We are seeking a highly strategic Clinical Study Operations Engineering Program Manager to provide flexible oversight across our study portfolio. Acting as a critical bridge between recruitment ...
Senior Clinical Trial Manager
Walnut Creek, CA · On-site
$160K - $190K/yr
Both studies are fully decentralized -- no in-person clinic visits -- with all assessments ... clinical trials (DCT) or hybrid trial models, including remote subject management, electronic ...
Quick apply
Senior Clinical Trial Manager
Walnut Creek, CA · On-site
$160K - $190K/yr
Both studies are fully decentralized -- no in-person clinic visits -- with all assessments ... clinical trials (DCT) or hybrid trial models, including remote subject management, electronic ...
We are seeking a highly strategic Clinical Study Operations Engineering Program Manager to provide flexible oversight across our study portfolio. Acting as a critical bridge between recruitment ...
We are seeking a highly strategic Clinical Study Operations Engineering Program Manager to provide flexible oversight across our study portfolio. Acting as a critical bridge between recruitment ...
Oversees aspects of study management and vendors to ensure high quality of data * Providing Clinical Research Associates with project-specific training, guidance, and oversight, assigning ...
Oversees aspects of study management and vendors to ensure high quality of data * Providing Clinical Research Associates with project-specific training, guidance, and oversight, assigning ...
The Senior Clinical Research Associate (Sr CRA) will independently manage all clinical aspects of a small to medium-sized clinical study or, with supervision, assume significant management ...
The Senior Clinical Research Associate (Sr CRA) will independently manage all clinical aspects of a small to medium-sized clinical study or, with supervision, assume significant management ...
Lead the Study Management Team (SMT) for assigned clinical study. * Resolve and/or escalate issues raised by the clinical operations team or the SMT. * Ensure consistency between studies for assigned ...
Lead the Study Management Team (SMT) for assigned clinical study. * Resolve and/or escalate issues raised by the clinical operations team or the SMT. * Ensure consistency between studies for assigned ...
Coordinate clinical study timelines with Project management and escalate issues that may impact timelines/ deliverables. * Leads and/or participates in the development and review of study documents ...
Coordinate clinical study timelines with Project management and escalate issues that may impact timelines/ deliverables. * Leads and/or participates in the development and review of study documents ...
Coordinate clinical study timelines with Project management and escalate issues that may impact ... timelines/ deliverables. * Leads and/or participates in the development and review of study ...
Coordinate clinical study timelines with Project management and escalate issues that may impact ... timelines/ deliverables. * Leads and/or participates in the development and review of study ...
The Senior Clinical Trial Manager (Sr CTM) is responsible for effective conduct of Ascendis' global ... Review monitoring reports for compliance to study protocols, regulations and ICH/GCP. Track and ...
The Senior Clinical Trial Manager (Sr CTM) is responsible for effective conduct of Ascendis' global ... Review monitoring reports for compliance to study protocols, regulations and ICH/GCP. Track and ...
Coordinate clinical study timelines with Project management and escalate issues that may impact ... timelines/ deliverables. * Leads and/or participates in the development and review of study ...
Coordinate clinical study timelines with Project management and escalate issues that may impact ... timelines/ deliverables. * Leads and/or participates in the development and review of study ...
Coordinate clinical study timelines with Project management and escalate issues that may impact timelines/ deliverables. * Leads and/or participates in the development and review of study documents ...
Coordinate clinical study timelines with Project management and escalate issues that may impact timelines/ deliverables. * Leads and/or participates in the development and review of study documents ...
Clinical Trials Manager, Early Phase Oncology (Office Based)
Foster City, CA · On-site
$146K - $189K/yr
We are seeking a Clinical Trials Manager (CTM) to support the Early Phase Oncology pipeline. The ... Maintains study timelines. * Contributes to development of study budget. * Contributes to ...
Clinical Trials Manager, Early Phase Oncology (Office Based)
Foster City, CA · On-site
$146K - $189K/yr
We are seeking a Clinical Trials Manager (CTM) to support the Early Phase Oncology pipeline. The ... Maintains study timelines. * Contributes to development of study budget. * Contributes to ...
We are seeking a Clinical Trials Manager (CTM) to support the Early Phase Oncology pipeline. The ... Maintains study timelines. * Contributes to development of study budget. * Contributes to ...
We are seeking a Clinical Trials Manager (CTM) to support the Early Phase Oncology pipeline. The ... Maintains study timelines. * Contributes to development of study budget. * Contributes to ...
Clinical Trials Manager, Early Phase Oncology (Office Based)
Foster City, CA · On-site
$146K - $189K/yr
We are seeking a Clinical Trials Manager (CTM) to support the Early Phase Oncology pipeline. The ... Maintains study timelines. * Contributes to development of study budget. * Contributes to ...
Clinical Trials Manager, Early Phase Oncology (Office Based)
Foster City, CA · On-site
$146K - $189K/yr
We are seeking a Clinical Trials Manager (CTM) to support the Early Phase Oncology pipeline. The ... Maintains study timelines. * Contributes to development of study budget. * Contributes to ...
Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization
Menlo Park, CA · On-site +1
Support development and review of key study documents including Monitoring Plans, Risk Management Plans, Study Oversight Plans, Clinical Trial Management Plans, and Site Management Plans.
Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization
Menlo Park, CA · On-site +1
Support development and review of key study documents including Monitoring Plans, Risk Management Plans, Study Oversight Plans, Clinical Trial Management Plans, and Site Management Plans.
Clinical Study Manager information
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Full-time
Retirement
Re-posted 15 days ago
Job description
TITLE: Senior Manager of Clinical Affairs
POSITION SUMMARY: The Clinical Affairs Senior Manager/Associate Director will be responsible for the design, execution and monitoring of clinical studies and will provide scientific expertise throughout the development and implementation of the studies. This role is accountable for the end-to-end clinical strategy, design, execution, oversight, and reporting of clinical studies supporting product development, regulatory submissions, and commercialization. S/he will work closely with R&D, Regulatory Affairs, Quality and external stakeholders to ensure high-quality, compliant, and efficient clinical programs and interact with regulatory agencies as needed to support regulatory submissions and audits.
The ideal candidate would act with passion and intensity in a medical device start-up that is fast paced and collaborative and display the ability to perform to the requirements outlined below. For the right person, this position will be a tremendously exciting and career-defining opportunity, offering the opportunity to shape clinical strategy for a novel medical robotic platform and to contribute meaningfully to the company's long-term success.
ROLES AND RESPONSIBILITIES:
Clinical Strategy and Leadership
- Lead the development and execution of the overall clinical strategy aligned with company and regulatory objectives.
- Provide expert input into clinical development plans, trial design, and evidence-generation strategies across the product lifecycle.
- Advise senior leadership on clinical risks, opportunities, and trade-offs.
Study Design, Execution, and Oversight
- Oversee the design, initiation, execution, monitoring, and closeout of clinical studies, ensuring adherence to timelines, budgets, and quality standards.
- Provide strategic oversight of CROs, vendors, investigators, and internal teams to ensure effective study conduct.
- Establish and monitor study performance metrics; proactively identify risks and lead cross-functional mitigation strategies.
- Participate in the development of clinical strategy and trial design.
Scientific and Regulatory Contributions
- Lead the development and review of key clinical documents, including protocols, amendments, investigator brochures, informed consent forms, case report forms, and clinical study reports.
- Interpret and synthesize clinical, scientific, and risk data to support regulatory submissions, scientific publications, and labeling claims.
- Facilitate regulatory submissions and communications. Interacts with regulatory agencies as needed and use scientific and medical knowledge to write strategic responses to questions from regulatory bodies about submissions.
Data Review, Safety, and Quality
- Provide oversight of clinical data review, including safety and adverse event evaluation, throughout study conduct and reporting.
- Ensure clinical activities are conducted in compliance with GCP, FDA, ISO, and applicable international regulations.
- Partner with Quality to develop and implement SOPs, support audits, complaint review, and implementation of corrective and preventive actions.
Operational and Financial Management
- Provide strategic oversight of clinical trial budgets, timelines, and resource planning.
- Lead or oversee contract negotiations with investigators, institutions, CROs, and other vendors.
- Drive continuous improvement of clinical processes, systems, and best practices.
REQUIRED QUALIFICATIONS:
- B.S. in Biomedical Engineering, Life Sciences or similar
- 7-10+ years of progressive experience in clinical research within the medical device industry, including leadership of complex clinical studies
- Demonstrated experience developing and executing clinical strategies that support regulatory submissions and product approvals.
- Strong working knowledge of Good Clinical Practice (GCP), FDA and international regulations, ISO standards and clinical research best practices
- Proven ability to lead cross-functional teams and influence without direct authority.
- Excellent written and verbal communication, skills including experience presenting to senior leadership and regulatory agencies
- High attention to detail and accuracy
- Fluent in medical terminology and sound knowledge of anatomy
- Strong analytical, problem-solving, and decision-making skills with high professional judgment.
- Ability to thrive in a fast-paced, evolving startup environment with a hands-on, ownership-oriented mindset
- Takes initiative and acts quickly to drive to solutions with a driven outlook and with a strong desire to succeed as a team player, and as a key part of a company
- Ability to travel up 20% domestically and internationally
PREFERRED QUALIFICATIONS:
- Experience in medical robotics
- Master's degree or higher in Biomedical Engineering, Life Sciences, or a related discipline
- Experience or knowledge of the GI/endoscopy space
Neptune Medical is located in Burlingame, CA, near the Millbrae Caltrain and BART Station
Our job titles may span more than one career level. The starting base salary for this role is between $182,500 and $229,000 depending on experience. The actual base pay is dependent upon many factors, such as: education, training, transferable skills, work experience, business needs, and location. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity, benefits and 401(K) with matching.
Neptune Medical provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
About Neptune Medical
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
1 - 10 Employees
Headquarters location
Burlingame, CA, US
Year founded
2016