Clinical Operations Manager

Philips International; Washington (District of Columbia); Remote; USD 113,000 - 182,000; Full time

Job summary

An innovative health technology company is seeking a Clinical Operations Manager to lead global clinical studies. This role involves strategic partnerships to optimize product life cycles and ensure compliance with regulations. The ideal candidate will have over 7 years of experience in clinical research within the medical device sector, strong knowledge of FDA requirements, and excellent communication skills. Join a forward-thinking organization dedicated to improving healthcare access and quality for everyone. If you're passionate about making a difference in people's lives through technology, this opportunity is perfect for you.

Benefits

Generous PTO

401k (up to 7% match)

HSA with company contribution

Stock purchase plan

Education reimbursement

Qualifications

• 7+ years of experience in clinical research within the medical device industry.
• Strong knowledge of clinical research standards and regulations.

Responsibilities

• Lead execution and management of clinical studies ensuring high quality data.
• Support daily updates and maintenance of the Clinical Trial Management System.

Skills

Clinical Research

FDA Requirements

ISO 14155 Standards

Communication Skills

Project Management

Education

Bachelor's Degree in Life Science

Master's Degree in Life Science

Tools

Clinical Trial Management System

Job description

Clinical Operations Manager page is loaded

Clinical Operations Manager

Apply locations Plymouth United States of America - Remote Based time type Full time posted on Posted 3 Days Ago job requisition id 544312

Job Title

Clinical Operations Manager

Job Description

Clinical Operations Manager

The Clinical Operations Manager will strategically partner to develop and deliver clinical studies globally for both internal and external stakeholders to optimize the product life cycle, with flawless execution.

Your role:

• Provide leadership in execution and management of clinical studies to deliver high quality data to support Philips businesses on time, within budget and in compliance with all applicable regulations and Philips procedures.
• Support output to Daily Leadership Board through consistent updates and maintenance of the Clinical Trial Management System.
• Ensure projects supported by clinical operations team have been prioritized, budgeted, and resourced by Product Managers.
• Ensure communication with team is strong, ensuring feedback is provided in real time through provision of mentoring and leadership coaching.
• Ensure global processes and procedures for clinical study execution are followed and gaps in understanding addressed through regular training.
• Ensure all audit requests, responses, and effectiveness checks are supported, addressed, and closed according to jointly agreed timelines.
• Support associate development to maintain the highest level of engagement.

You're the right fit if:

• You’ve acquired 7+ years of experience in clinical research within the medical device industry. You have experience working with FDA requirements, as well as strong knowledge of other global standards (EUMDR, NMPA, PMDA, etc.).
• Your skills include strong knowledge of relevant standards and regulations for clinical research in the medical device industry (ISO 14155, 21 CFR Parts 812 and 820, GCP, etc.). You have worked in clinical research hands on, with experience reviewing clinical study research data.
• You have a bachelor’s degree or higher in Life Science or equivalent. Master’s degree or higher preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You’re an excellent communicator with a demonstrated ability to successfully influence cross-functional teams without having expressed authority. Prior management experience preferred but not required. This role requires up to 25% of travel as required by business needs.

How we work together

We believe that we are better together than we are 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 a field-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 of healthcare that we all deserve. Do the work of your life to help improve the lives of others.

Philips Transparency Details

The pay range for this position in AZ, AR, ID, IA, KS, KY, LA, ME, MS, MO, MT, NE, NM, OK, SC, SD, TN, UT, and WV are $96,188 to $153,900.

The pay range for this position in AL, CO, FL, GA, IL, IN, MI, MN, NV, NH, NC, ND, OH, OR, PA, TX, VT, VA, WI, and WY are $101,250 to $162,000.

The pay range for this position in AK, DE, HI, MD, RI, and WA is $106,313 to $170,100.

The pay range for this position in CA, CT, MA, NJ, NY, DC, is $113,400 to $181,440.

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.

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.

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/Disabled/Veteran and maintains a drug-free workplace.