Oversee end-to-end study startup and execution, including site feasibility, investigator selection ... Ensure all clinical studies are inspection ready and executed in accordance with ICH GCP, ISO ...
Oversee end-to-end study startup and execution, including site feasibility, investigator selection ... Ensure all clinical studies are inspection ready and executed in accordance with ICH GCP, ISO ...
Oversee end-to-end study startup and execution, including site feasibility, investigator selection ... Ensure all clinical studies are inspection ready and executed in accordance with ICH GCP, ISO ...
Oversee end-to-end study startup and execution, including site feasibility, investigator selection ... Ensure all clinical studies are inspection ready and executed in accordance with ICH GCP, ISO ...
Research Professional 2 - Lillehei Clinical Research Unit/Cardiovascular
Minneapolis, MN · On-site
$55K - $70K/mo
Follow Good Clinical Practice (GCP) guidelines in the conduct, performance and documentation of ... Facilitate study startup activities following guides and checklists to implement protocols, assess ...
Research Professional 2 - Lillehei Clinical Research Unit/Cardiovascular
Minneapolis, MN · On-site
$55K - $70K/mo
Follow Good Clinical Practice (GCP) guidelines in the conduct, performance and documentation of ... Facilitate study startup activities following guides and checklists to implement protocols, assess ...
Clinical Project Manager - Oncology (Client Dedicated/Remote) Syneos Health is a leading fully ... Lead day-to-day study management activities across study startup, conduct, maintenance, and ...
Clinical Project Manager - Oncology (Client Dedicated/Remote) Syneos Health is a leading fully ... Lead day-to-day study management activities across study startup, conduct, maintenance, and ...
Study Start Up Associate II - Medical Device
Arden Hills, MN · On-site +1
$35.25 - $48/hr
Update and maintain study-specific startup and close out trackers. * Update and maintain site specific metrics in Clinical Trial Management Systems, file and maintain site documents in eTMFs.
Study Start Up Associate II - Medical Device
Arden Hills, MN · On-site +1
$35.25 - $48/hr
Update and maintain study-specific startup and close out trackers. * Update and maintain site specific metrics in Clinical Trial Management Systems, file and maintain site documents in eTMFs.
Medical Science Liaison
Minneapolis, MN · On-site
$190K - $210K/yr
Partner with Clinical Development, Clinical Operations, CRO partners, and investigative sites to support effective study startup, protocol understanding, and trial execution. * Execute nonpromotional ...
Medical Science Liaison
Minneapolis, MN · On-site
$190K - $210K/yr
Partner with Clinical Development, Clinical Operations, CRO partners, and investigative sites to support effective study startup, protocol understanding, and trial execution. * Execute nonpromotional ...
Clinical Safety Specialist
$88K - $105K/yr
As a growing medical device startup, every team member plays a critical role in advancing ... Ensure completeness and accuracy of clinical study data, Data entry into the clinical trial ...
Clinical Safety Specialist
$88K - $105K/yr
As a growing medical device startup, every team member plays a critical role in advancing ... Ensure completeness and accuracy of clinical study data, Data entry into the clinical trial ...
As a growing medical device startup, every team member plays a critical role in advancing ... clinical studies Thorough review source documents and identifying missing information Ensure ...
As a growing medical device startup, every team member plays a critical role in advancing ... clinical studies Thorough review source documents and identifying missing information Ensure ...
Clinical Safety Specialist
Maple Grove, MN · On-site
$88K - $105K/yr
As a growing medical device startup, every team member plays a critical role in advancing ... Ensure completeness and accuracy of clinical study data, Data entry into the clinical trial ...
Clinical Safety Specialist
Maple Grove, MN · On-site
$88K - $105K/yr
As a growing medical device startup, every team member plays a critical role in advancing ... Ensure completeness and accuracy of clinical study data, Data entry into the clinical trial ...
Site Network Manager (North America)
$97K - $163K/yr
Strong understanding of the clinical trial lifecycle , including site feasibility, study startup, patient recruitment, and ICH-GCP/regulatory requirements. * Excellent relationship management ...
Site Network Manager (North America)
$97K - $163K/yr
Strong understanding of the clinical trial lifecycle , including site feasibility, study startup, patient recruitment, and ICH-GCP/regulatory requirements. * Excellent relationship management ...
Perform study startup, implementation, and closeout activities * Assist research team with ... Good Clinical Practice guidelines * Interact with patients and families for securing informed ...
Perform study startup, implementation, and closeout activities * Assist research team with ... Good Clinical Practice guidelines * Interact with patients and families for securing informed ...
Becomes proficient with all study databases, systems and company quality management system ... driven startup environment while also having fun. Salary range for U.S locations (USD): 85,000 ...
Becomes proficient with all study databases, systems and company quality management system ... driven startup environment while also having fun. Salary range for U.S locations (USD): 85,000 ...
Support clinical study execution and CLIA-LDT lab setup, including sample kitting, shipment, and ... Willingness to work in a fast-paced, dynamic, lean-startup environment. * Comfort working in BSL-2 ...
Quick apply
Support clinical study execution and CLIA-LDT lab setup, including sample kitting, shipment, and ... Willingness to work in a fast-paced, dynamic, lean-startup environment. * Comfort working in BSL-2 ...
Project Manager I - Cell & Gene Therapy (Sponsor Dedicated - US Remote; Preference for Hybrid Los An
Minneapolis, MN · On-site
Our Clinical Solutions team members act with a drug development mindset, applying their years of ... startup through closeout. * Lead or support study start-up, site activation, and enrollment ...
Project Manager I - Cell & Gene Therapy (Sponsor Dedicated - US Remote; Preference for Hybrid Los An
Minneapolis, MN · On-site
Our Clinical Solutions team members act with a drug development mindset, applying their years of ... startup through closeout. * Lead or support study start-up, site activation, and enrollment ...
Senior Manager, Sterility Assurance
Rochester, MN · On-site
$110K - $165K/yr
... facility startup, GMP operations, process validation, inspection readiness, and continuous ... Develop long-term sterility assurance strategies to support clinical and future commercial ...
Quick apply
Senior Manager, Sterility Assurance
Rochester, MN · On-site
$110K - $165K/yr
... facility startup, GMP operations, process validation, inspection readiness, and continuous ... Develop long-term sterility assurance strategies to support clinical and future commercial ...
... clinical champions to C-suite executives. * Use storytelling, success metrics, and case studies to ... We are a global industrial technology innovator with a startup spirit. Our forward-looking ...
... clinical champions to C-suite executives. * Use storytelling, success metrics, and case studies to ... We are a global industrial technology innovator with a startup spirit. Our forward-looking ...
Medical Device Account Executive - Minneapolis, MN
Minneapolis, MN · On-site +1
$220K/yr
... the time clinicians spend analyzing, scoring and managing sleep studies. This results in a ... Previous experience at a startup, tech, software engineering, or similar company is a bonus
Medical Device Account Executive - Minneapolis, MN
Minneapolis, MN · On-site +1
$220K/yr
... the time clinicians spend analyzing, scoring and managing sleep studies. This results in a ... Previous experience at a startup, tech, software engineering, or similar company is a bonus
Medical Device Account Executive - Minneapolis, MN
Minneapolis, MN · On-site +1
$220K/yr
... the time clinicians spend analyzing, scoring and managing sleep studies. This results in a ... Previous experience at a startup, tech, software engineering, or similar company is a bonus
Medical Device Account Executive - Minneapolis, MN
Minneapolis, MN · On-site +1
$220K/yr
... the time clinicians spend analyzing, scoring and managing sleep studies. This results in a ... Previous experience at a startup, tech, software engineering, or similar company is a bonus
... development, clinical and commercial manufacturing, and packaging of complex oral solid dose ... Reads understands and follows the current USP/NF, laboratory SOPs, analytical methods and study ...
... development, clinical and commercial manufacturing, and packaging of complex oral solid dose ... Reads understands and follows the current USP/NF, laboratory SOPs, analytical methods and study ...
Clinical Study Startup information
What is a Clinical Study Startup job?
A Clinical Study Startup job involves managing the initial phases of a clinical trial, ensuring all regulatory, ethical, and logistical requirements are met before patient enrollment begins. Responsibilities typically include submitting regulatory documents, coordinating with ethics committees, negotiating contracts, and ensuring trial sites are fully prepared. This role requires strong knowledge of clinical research regulations, timelines, and collaboration with internal and external stakeholders. Effective study startup is crucial for minimizing delays and ensuring compliance with industry standards.
What are the key skills and qualifications needed to thrive in the Clinical Study Startup position, and why are they important?
Success in a Clinical Study Startup role requires a strong understanding of clinical research processes, regulatory requirements, project management, and often a life sciences degree or related field. Familiarity with clinical trial management systems (CTMS), electronic trial master files (eTMF), and regulatory submission platforms is essential, along with certifications like GCP (Good Clinical Practice) being advantageous. Attention to detail, proactive problem-solving, and excellent organizational and communication skills help candidates excel. These qualifications ensure smooth study initiation, regulatory compliance, and effective cross-functional collaboration within demanding timelines.
What are the typical responsibilities of someone working in Clinical Study Startup?
Professionals in Clinical Study Startup are primarily responsible for coordinating and executing study initiation activities, including regulatory document collection, ethics submissions, site contracting, and start-up logistics. They work closely with investigators, sponsors, and cross-functional teams to ensure all regulatory and site requirements are met before the clinical trial begins. This role often involves tight deadlines and frequent communication with stakeholders both internally and externally. It's a fast-paced position that is ideal for individuals who enjoy detail-oriented work and project coordination in a collaborative environment.
- Freelance Clinical Research Associate
- Online Clinical Research
- Clinical Trial Report Reviewer
- Sr Clinical Research Coordinator
- Clinical Research Data Assistant
- Seasonal Senior Clinical Research Associate
- Clinical Trials
- Clinical Trial Research Coordinator
- Centralized Monitor Clinical Research
- Research Participants

Full-time
Retirement, PTO
Posted 13 days ago
Philips rating
8.3
Based on 82 frontline employees who took The Breakroom Quiz
41st of 155 rated electronics manufacturers
Job description
Director of Clinical Operations
Job Description
Director of Clinical Operations, Image Guided Therapy Devices
The Director of Clinical Operations, IGTD, oversees day-to-day clinical program operations, ensuring progress against goals while leading complex negotiations with regulatory bodies, sites, and vendors and streamlining operations through innovative methodologies. This role partners with executive leadership and cross-functional teams across IT, Clinical/Medical, Regulatory, Legal, Quality, Procurement, and Finance to shape large-scale research strategy, analyze industry trends, advise stakeholders, manage vendors and deliverables as Product Owner, and provide clear reporting to senior leadership and regulatory authorities.
Your role:
- Lead the operational planning and execution of clinical trials and evidence generation programs across Coronary, Peripheral, and Cardiac Solutions, including early feasibility, pivotal, pre-market, post-market, registry, real-world evidence, and investigator-initiated or company-sponsored studies. Translate clinical evidence strategies and protocols into executable plans covering timelines, enrollment, site activation, monitoring, vendors, budgets, resourcing, and risk mitigation.
- Oversee end-to-end study startup and execution, including site feasibility, investigator selection, contract and budget coordination, ethics committee and IRB submissions, site initiation, patient enrollment, monitoring, data collection, protocol compliance, deviation management, adverse event workflows, documentation, and closeout.
- Ensure all clinical studies are inspection ready and executed in accordance with ICH GCP, ISO standards, FDA and global regulatory requirements, local country requirements, and Philips quality and compliance policies. Partner with Regulatory, Quality, and Clinical Affairs to support regulatory submissions, clinical evaluations, annual reports, post-market surveillance needs, and timely delivery of high-quality evidence outputs.
- Manage clinical operations governance, vendor oversight, and performance management across CROs, core and imaging laboratories, data management partners, safety vendors, electronic data capture providers, and other external study partners. Establish operating rhythms for study team meetings, enrollment reviews, budget reviews, milestone tracking, risk escalation, and senior leadership updates.
- Build, lead, and develop a high-performing Clinical Operations team with clear goals, accountability, execution discipline, collaboration, and continuous improvement. Represent Clinical Operations in governance forums, core team meetings, product development discussions, senior management reviews, and external discussions with investigators, vendors, and regulatory authorities as needed.
You're the right fit if:
- You have acquired 10+ years of directly related clinical research or clinical operations experience, preferably within the medical device industry, including 5+ years leading or managing clinical operations teams. You have a demonstrated track record of delivering complex clinical studies on time, within budget, and in compliance with applicable requirements.
- You have deep knowledge of clinical trial execution across the product lifecycle, including study startup, site activation, enrollment, monitoring, vendor management, data collection, closeout, inspection readiness, budgets, contracts, timelines, site performance, vendor deliverables, and operational risk. Your expertise includes ICH GCP, ISO 14155, FDA medical device regulations, informed consent, adverse event reporting, protocol deviation management, clinical trial documentation, trial master file expectations, and global regulatory and operational requirements.
- You have a bachelor's degree in a scientific, clinical, health sciences, engineering, or related discipline; an advanced scientific, clinical, regulatory, public health, or business degree is preferred. Experience with cardiovascular, peripheral vascular, coronary, electrophysiology, structural heart, image guided therapy, catheter-based technologies, global clinical trial execution, and digital clinical trial systems is highly desirable.
- You are a strong clinical operations leader who can translate strategy and study design into practical trial plans, build collaborative relationships, influence through direct and indirect reporting lines, communicate effectively with clinical, regulatory, technical, executive, vendor, and external audiences, and create a culture of accountability, process improvement, and excellence. You are able to supervise exempt and non-exempt employees, oversee vendors and external partners, support hiring and performance management decisions, and travel domestically and internationally approximately 20-30% of the time.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.
This is an office-based role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
- Learn more about our business
- Discover our rich and exciting history.
- Learn more about our purpose.
- Learn more about our culture.
Philips Transparency Details
The pay range for this position in Colorado Springs is $171,000 to $273,000.
The pay range for this position in Plymouth, MN is $180,000 to $287,000.
The pay range for this position in Bothell, WA, San Diego, CA, Cambridge, MA, Bedford, MA is $192,000 to $306,000.
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional Information
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to posted locations
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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.