Job Closed

This listing is no longer active.

Hologic logo
Hologic

Hologic is a leader in women's health innovation, empowering people to live healthier lives every day. Our engineering teams are the driving force behind our business, constantly challenging and innovating our processes.

Clinical Operations Quality Manager

Clinical OperationsClinical OperationsOtherRemoteLeadTeam 5,001-10,000

Location

United States

Posted

110 days ago

Salary

$116.5K - $182.2K / year

Seniority

Lead

Job Description

Clinical Operations Quality Manager

Hologic

As a key member of the Breast and Skeletal Health (BSH) Clinical Affairs team, the Clinical Operations Quality Manager will oversee and execute major US-based and global clinical trials across multiple phases of product development, with a strong focus on quality oversight and quality assurance. You will work alongside a high-performing team of clinical development and operations experts to generate high-quality clinical evidence in support of innovative breast and skeletal health technologies. This role requires close collaboration with global regional teams and cross-functional partners, including Clinical Development, R&D, Program Management, Regulatory Affairs, Legal, Marketing, Service, and Operations. This position is ideal for a seasoned clinical operations professional with broad experience who can apply professional concepts and company objectives to resolve complex issues in creative and effective ways, while ensuring the highest standards of quality and compliance. This is a remote opportunity. Key Responsibilities - Lead the planning, execution, and oversight of clinical studies from start-up through close-out, ensuring trials are conducted according to established quality standards, protocols, and regulatory requirements. - Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory standards for clinical trials. - Critically review study-related documentation, including protocols, informed consent forms, site instructions, study manuals, eCRFs, data review plans, IRB submissions, IDE applications, and other trial documentation. - In collaboration with the Clinical team, select and manage CROs and other external vendors/consultants, including: - Contract and budget negotiation - Oversight of CRO activities from award through trial closeout - Oversee quality assurance and monitoring activities related to clinical trials. - Contribute to the creation, review, and maintenance of Standard Operating Procedures (SOPs) governing clinical operations activities. - Participate in the preparation of regulatory filings and support interactions with regulatory bodies, as needed. - Develop and implement processes and tools to improve the efficiency and effectiveness of clinical operations from a quality perspective. - Implement and maintain quality assurance processes, including audits, monitoring, and quality control checks. - Identify, manage, and resolve deviations from established quality standards and procedures; initiate and support CAPA as required. - Prepare reports on quality metrics and maintain accurate, timely documentation of quality-related activities in the Quality Management System (QMS). - Perform other function-related duties as required by business needs. Qualifications Education & Experience - Bachelor’s Degree required with 8+ years of relevant experience; or - Master’s Degree with 6+ years of experience; or - PhD with 3+ years of experience. - Experience running clinical trials and working for a sponsor or CRO in the medical device industry. - Experience developing and managing academic–industry partnerships. - Proven experience in the management of quality processes within clinical operations. Skills & Competencies - Strong track record in managing complex clinical studies and trials, ideally in medical devices. - Clinical or research experience in breast cancer screening, diagnostics, and/or treatment domains strongly preferred. - In-depth understanding of quality processes and regulatory requirements in the medical device space, including GCP and ICH guidelines. - Demonstrated ability to conduct audits and quality checks, and to initiate and manage CAPA when required. - Excellent oral and written communication skills, including strong presentation skills and the ability to effectively represent and communicate the company’s position to internal and external stakeholders. - Proven interpersonal skills and success in a matrixed, cross-functional environment. - Strong organizational skills with the ability to multi-task, manage multiple projects, and adapt to changing priorities. - Strategic thinker with the ability to set and manage priorities and allocate resources effectively. - Collaborative, team-oriented mindset with a focus on achieving shared goals. So why join Hologic? We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you. The annualized base salary range for this role is $116,500 - $182,200 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. LI-#DS1

Related Categories

Related Job Pages

More Clinical Operations Jobs

Arine logo

Clinical Support Lead

Arine

Arine optimizes medication to ensure each patient is on the safest, most effective therapy for their unique health needs

OtherRemoteTeam 11-50H1B No Sponsor

Based in San Francisco, Arine is a rapidly growing healthcare technology and clinical services company with a mission to ensure individuals receive the safest and most effective treatments for their unique and evolving healthcare needs.  Frequently, medications cause more harm than good. Incorrect drugs and doses costs the US healthcare system over $528 billion in waste, avoidable harm, and hospitalizations each year. Arine is redefining what excellent healthcare looks like by solving these issues through our software platform (SaaS). We combine cutting edge data science, machine learning, AI, and deep clinical expertise to introduce a patient-centric view to medication management, and develop and deliver personalized care plans on a massive scale for patients and their care teams. Arine is committed to improving the lives and health of complex patients that have an outsized impact on healthcare costs and have traditionally been difficult to identify and address. These patients face numerous challenges including complicated prescribing issues across multiple medications and providers, medication challenges with many chronic diseases, and patient issues with access to care. Backed by leading healthcare investors and collaborating with top healthcare organizations and providers, we deliver recommendations and facilitate clinical interventions that lead to significant, measurable health improvements for patients and cost savings for customers.  Why is Arine a Great Place to Work?: Outstanding Team and Culture - Our shared mission unites and motivates us to do our best work. We have a relentless passion and commitment to the innovation required to be the market leader in medication intelligence. Making a Proven Difference in Healthcare - We are saving patient lives, and enabling individuals to experience improved health outcomes, including significant reductions in hospitalizations and cost of care. Market Opportunity - Arine is backed by leading healthcare investors and was founded to tackle one of the largest healthcare problems today. Non-optimized medications therapies which cost the US 275,000 lives and $528 billion annually. Dramatic Growth - Arine is managing more than 18 million lives across prominent health plans after only 4 years in the market, and was ranked 236 on the 2024 Inc. 5000 list and was named the 5th fastest-growing company in the AI category. The Role: We are looking for a Lead Clinical Support Specialist to assist in leading one of the clinical teams that uses the Arine platform to deliver excellent outcomes for our customers.  The purpose of the Lead Clinical Support Specialist position is to assist in managing a patient engagement program that achieves five-star results across a variety of Medicare Part C and Part D measures. The Lead Clinical Support Specialist partners with the Lead Clinical Pharmacist to achieve these results by setting a strategic approach with Arine leadership and with other Clinical Care Leads, by managing a dedicated Clinical Care Support team that engages patients, providers and pharmacists to drive excellent medication outcomes, and engaging client teams and Arine Customer Success to align expectations and communicate roadblocks and progress.  This role encompasses all of Arine's Clinical Care team activities. You will be asked to: - Support oversight of goals, progress, and resource allocation of an Arine full-service clinical project - Develop intervention strategies to optimize medication utilization, achieve quality measures, and other established goals - Manage team productivity and timelines to ensure goals are met  - Ensure quality assurance standards are met - Represent Arine’s Clinical Care team at customer meetings, as well as lead internal staff meetings - Hire, train, and schedule team members and help lead in the growth and development of the team - Manage and conduct performance reviews for assigned team members - Respond to questions by patients, providers, and other professional personnel and team members - Comply with all company policies and state and federal rules and regulations Who You Are and What You Bring: - At least 12 months experience managing a Clinical, Patient or Customer Support Team, with a track record of excellence and demonstrated leadership (required), experience within the healthcare field preferred. - Team management and coaching experience required, preferably within a remote setting. - Excellent analytical skills - Ability to quickly problem solve and triage both clinical and operational situations  - Ability to organize and set priorities which accurately reflect the relative importance of job responsibilities - Excellent communication and project management skills - Ability to engage with the patients, promote adherence and treat patients with empathy and compassion - Strong grasp of standard workflows for medication adherence  - Ability to apply judgment and make informed decisions in order to work independently and meet deadlines - Ability to work effectively within a team and foster effective working relationships and build consensus - Eagerness to learn new skills in a fast-paced, dynamic environment - Strong computer skills, including facility with Microsoft Word, Excel, Google Spreadsheets, and Google Documents Remote Work Requirements: - An established private work area that ensures information privacy - A stable high-speed internet connection for remote work - This role is remote, but you will be required to come to on-site meetings multiple times per year. This may be in the interview process, onboarding, and team meetings Perks: Joining Arine offers you a dynamic role and the opportunity to contribute to the company's growth and shape its future. You'll have unparalleled learning and growth prospects, collaborating closely with experienced Clinicians, Engineers, Software Architects, and Digital Health Entrepreneurs. The posted salary range represents the expected base annual salary for this position and does not include any other potential components of the compensation package, benefits, and perks. Ultimately, the final pay decision will consider factors such as your experience, job level, location, and other relevant job-related criteria. The base annual salary range for this position is $55,000 - $60,000. Job Requirements: - Ability to pass a background check - Must live in and be eligible to work in the United States Information Security Roles and Responsibilities: All staff at Arine are expected to be part of its Information Security Management Program and undergo periodic training on Information Security Awareness and HIPAA guidelines. Each user is responsible to maintain a secure working environment and follow all policies and procedures. Upon hire, each person is assigned and must complete trainings before access is granted for their specific role within Arine. Arine is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Check our website at https://www.arine.io. This is a unique opportunity to join a growing start-up revolutionizing the healthcare industry! Job Offers: Arine uses the arine.io domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam.  Note to Recruitment Agencies: We appreciate your interest in finding talent for Arine, but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Arine without a prior written agreement in place will be considered property of Arine, and no fee will be paid in the event of a hire. Thank you for your understanding.

United States
Job Closed
HISTOSONICS INC logo

Senior Procedure Development Specialist

HISTOSONICS INC

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients. Location: Remote Travel: up to 70% Position Summary The Sr. Procedure Development Specialist will collaborate with stakeholders to develop and implement innovative procedural solutions for current and future indications of the Company’s system(s). This role is pivotal in optimizing workflows, driving continuous improvement initiatives, and ensuring procedural standardization across various clinical applications. The Procedure Development Specialist, Sr. will work closely with cross-functional teams, including R&D, clinical research, regulatory, and commercial teams, to enhance procedural efficiency and support clinical adoption. Position Expectations - Lead, mentor, and develop Procedure Development Specialists and Clinical Education Specialists across the Company’s system(s) and indications. - Participate in the planning, execution, and documentation of scientific and engineering experiments related to acoustical, electrical, and mechanical system components. - Collaborate with R&D, regulatory affairs, and clinical teams to define requirements, and design outputs that align with customer and clinical needs. - Act as a primary technical resource for the Company’s system(s) during clinical trials and feasibility studies. - Develop and execute training programs for global and domestic clinical studies. - Participate in the execution of formative, summative, and post-market assessments to inform feature development and procedural workflows. - Work cross-functionally with education to support ongoing learning and development of the team. - Work closely with the HistoSonics Education, Marketing, Sales and R&D teams to deliver world-class customer and employee training and education programs that enhance the value of the organization. - Support and train internal education and clinical teams on new features, indications and continuous improvement projects (system, subsystem and software). - Implement continuous improvement initiatives to enhance workflow efficiency and ensure best practices across indications. Qualifications: - Bachelor’s degree in a relevant field required (e.g., Biomedical Engineering, Life Sciences, Nursing, or related discipline); advanced degree preferred - 5+ years of clinical and educational experience with advanced imaging technologies (US, CT, MRI, IR). - General or abdominal sonography experience required. - Active ARDMS certification required. - 5+ years of Direct clinical patient care experience in health care/medical industry required. - Proven ability to collect, synthesize, and communicate user feedback to internal teams to drive continuous product improvement. - Demonstrated success in collaborating with cross-functional teams (R&D, marketing, clinical, regulatory, and engineering) to define new technology features and enhancements. - Strong understanding of clinical workflows, hospital environments, and device integration in surgical or diagnostic settings. - Excellent communication, presentation, and interpersonal skills, with the ability to engage effectively with clinicians, KOLs, and internal stakeholders. - Ability to translate clinical needs into technical requirements and contribute to product development discussions. - Familiarity with human factors engineering, usability studies, or post-market surveillance. - Strong analytical mindset and ability to interpret user data, metrics, and clinical outcomes to inform development priorities. - Demonstrated experience helping to launch or iterate new medical device technologies based on end-user feedback. - Experience with clinical trial protocols, Good Clinical Practice (GCP), and medical device risk management is a plus. - Travel up to 70% of the time both domestically and internationally. Benefits: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

United States
$140K - $155K / year
Job Closed
Jobgether logo

Senior Director of Clinical Operations

Jobgether

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

OtherRemoteH1B No Sponsor

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior CDO TA Executive Director - REMOTE. In this influential leadership role, you will drive innovation and operational excellence in clinical development programs focused on Eye Health. The position combines strategic oversight with hands-on management, ensuring that projects meet industry benchmarks for speed and quality. You will collaborate globally to inspire teams, influence industry standards, and forge strategic partnerships, all while delivering significant value for healthcare systems and patients. This role provides a unique opportunity to lead with purpose on a global scale, shaping the future of clinical operations within this vital therapeutic area. - Develop and implement operational strategy to optimize clinical development programs in Eye Health. - Oversee governance and execution of clinical programs, ensuring alignment with strategic goals. - Manage clinical program budgets, monitoring financial performance and adherence to targets. - Lead cross-functional teams and act as the functional manager for Clinical Development Operations Leads. - Foster strategic partnerships by engaging with external stakeholders and representing the organization. - Promote digital innovation and integration in clinical studies using data-driven approaches. Qualifications - MD or PhD desirable; minimum of a life sciences degree with 15+ years in clinical development. - Strong leadership skills and strategic thinking to implement operational strategies effectively. - Deep knowledge of clinical development processes, with Eye Health experience preferred. - Financial acumen to manage budgets and ensure financial targets are met. - Excellent collaboration and communication abilities with various stakeholders. - Experience with digital tools and data-driven methodologies for study design and patient engagement. - Current with industry trends to promote compliance and continuous improvement in operations. Benefits - Competitive salary range of $250,000 to $394,000. - Role-specific discretionary bonuses and potential relocation assistance. - Opportunity for international collaboration and visibility. - Supportive environment fostering work-life balance and employee well-being. - Access to comprehensive benefits programs reflecting high regard for employees.

United States
Job Closed
West Coast University logo

Director, Clinical Operations – Online

West Coast University

Together let's do the extraordinary. Get ready to transform futures, including your own.

Full TimeRemoteTeam 1,001-5,000Since 1909H1B No Sponsor

• Management of the clinical education team for the online campus • Oversee placement of students for clinical rotations • Work closely with the academic team to meet course objectives • Implement streamlined processes and communication tools • Optimize software platforms for visibility of contract activities • Provide administrative oversight for the preceptorship program • Collaborate on preceptorship placement with Regional Directors • Ensure compliance documentation is accurate • Manage incidents reported at sites • Maintain effective operations and staff engagement

United States
$110.3K - $159.9K / year