Clinical Study Manager

Job Title

Job Description

Clinical Study Manager

The Clinical Study Manager oversees the execution and regulatory compliance of clinical studies managing documentation negotiations and team priorities to ensure program objectives are met. The role maintains alignment with Philips standards provides updates to senior management and ensures readiness for audits.

Your role:

• Conducts and oversees all aspects of clinical studies ensuring strict compliance with regulatory standards (ISO GCP FDA) and Philips procedures including site assessments monitoring training and close-out activities.
• Serves as a key resource and subject matter expert for study sites and investigators offering guidance on protocol requirements study procedures and regulatory expectations while reviewing project documentation for accuracy and compliance.
• Optimizes study efficiency and data quality through process improvements thorough data review and verification leveraging clinical trial technologies such as EDC eTMF and CTMS proficiently.
• Collaborates and builds effective relationships across Clinical Medical Biostatistics Data Management Regulatory Quality R&D and other internal teams to achieve project goals and ensure seamless study execution.
• Monitors study progress against milestones timelines and budgets; proactively identifies risks resolves issues and drives continuous improvement initiatives to ensure regulatory compliance and data integrity.

Youre the right fit if:

• Youve acquired 5 years of experience in execution of clinical research in the medical device industry (preferred) pharma biotech academia or government research required.
• Your skills include knowledge of medical device clinical trials design and best practices (strongly preferred); familiarity with relevant medical device standards preferred (ISO ICH/GCP guidelines etc.).
• You have a Doctorate degree or higher in a related field.
• You must be able to successfully perform the following minimum Physical Cognitive and Environmental job requirements with or without accommodation for this position.
• You have strong attention to detail have a learner mindset and are coachable. Up to 10% travel required based on business needs. You must be based in the local Pittsburgh PA area for proximity to study site locations.

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 companys facilities. Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations.

This is a field-based role requiring candidates to be local to Pittsburgh PA.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters and we wont 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 PA is $101250 to $162000.

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.

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.