CT Clinical Study Manager

Philips; Teletrabalho; BRL 557.000 - 1.000.000; Tempo integral

Resumo da oferta

A health technology company is seeking a Clinical Study Manager for Computed Tomography. Responsibilities include managing clinical studies, ensuring compliance with regulations, and providing guidance to study sites. The ideal candidate will have over 3 years of experience in clinical research in the medical device sector, excellent project management skills, and a Bachelor's or Master's degree in Life Sciences. This role requires travel and is focused on maintaining high standards of data integrity and regulatory compliance.

Serviços

Generous PTO

401k with up to 7% match

Education reimbursement

Stock purchase plan

Qualificações

• 3+ years of related experience in clinical research execution in the medical device industry.
• Profound knowledge of clinical research process legislation and ICH-GCP guidelines.
• Ability to perform job requirements with or without accommodations.
• Strong analytical, project management, and communication skills.

Responsabilidades

• Manage and execute clinical studies adhering to protocols and regulatory standards.
• Provide guidance to study sites and investigators on regulatory requirements.
• Enhance clinical research processes through data review and optimization.
• Collaborate with internal and external partners to achieve project objectives.
• Monitor study progress and deliver updates to leadership.

Conhecimentos

Clinical research execution

Project management

Analytical skills

Communication skills

Formação académica

Bachelor’s or Master’s degree in Life Sciences or equivalent

Ferramentas

EDC

CTMS

eTMF systems

Descrição da oferta de emprego

Clinical Study Manager, Computed Tomography (EST Time zone)

The Clinical Study Manager will be responsible for the execution and regulatory compliance of clinical studies for our Computed Tomography business.

Your role:

• Manages and executes clinical studies with strict adherence to protocols, regulatory standards (ISO, GCP, FDA), and Philips procedures, ensuring data accuracy, integrity, and effective handling of deviations.
• Provides expert guidance and support to study sites and investigators on regulatory requirements, protocol adherence, and Good Clinical Practice, while reviewing study documentation for completeness and compliance.
• Enhances and streamlines clinical research processes through continuous data review, process optimization, and proactive resolution of queries and discrepancies related to study conduct and regulatory compliance.
• Collaborates and communicates effectively with internal cross‑functional teams and external partners, facilitating alignment, issue resolution, and achievement of project objectives throughout the study lifecycle.
• Monitors study progress, milestones, and budgets, conducts trend analysis for risk mitigation, and delivers timely study updates and recommendations to leadership and senior management.

You're the right fit if:

• You’ve acquired 3+ years of related experience in clinical research execution in the medical device industry. Experience using EDC, CTMS, and eTMF systems is highly preferred.
• Your skills include profound knowledge of clinical research process legislation and ICH‑GCP guidelines.
• You have a Bachelor’s / master’s degree or higher in Life Sciences or an equivalent 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 demonstrated strong analytical, project management, and communication skills; thrive in cross‑functional environments, and are committed to maintaining high standards of data integrity and regulatory compliance. Must be willing to travel up to 50% globally to study sites, based on business needs.

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 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 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 AL, FL, GA, MI, NH, NC, OH, PA, VT, VA, WI is $101,250 to $162,000.

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

The pay range for this position in 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. 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.

#LI-PH1

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.