Senior Clinical Research Associate

Job Title

Job Description

Strategically partner to monitor and manage clinical projects and clinical staff globally for both internal and external stakeholders to optimize product life cycle. Manage study documents, materials, devices, financial documents and clinical trial management systems.

Your role:

• Ensure the clinical studies are monitored and conducted according to procedures including up to date and complete trial master files, regular review of data, and assurance that monitoring reports and follow-up documentation are completed and updates uploaded in CTMS.

• Qualifies, Selects, Trains and Monitors internal and external study Investigators and study documentation.

• Oversee and support the creation of the Purchase Orders (PO), trial master file, regulatory binder, source documents, and investigational product ordering, shipping, and associated documentation.

• Continuously improving the efficiency and compliance of Clinical research activities by streamlining day-to-day workflow and processes and identification and adoption of improved information management and project management applications and tools.

You're the right fit if:

• BS/BA in Scientific or relevant Healthcare discipline and 3+ years related experience in conduct and monitoring of clinical studies (healthcare setting, CRO, medical device and/or pharmaceutical company and/or industry). Project Management experience is required.

• A demonstrated working knowledge of GCP, ICH guidelines, ISO Standards, FDA/EU regulations

• Experience in using EDC/ CTMS and knowledge of information management and workflow management applications (such as SharePoint, excel, and Confluence) and demonstrated learning agility to learn new applications and tools to drive disruptive efficiency.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

• Flexibility in work hours and readiness to travel.  Travel may be up to 50% but typically no more than 25% per month.

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 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 commitment to diversity and inclusion.

Philips Transparency Details

The pay range for this position in Massachusetts is $89,376 to $153,216 annually. 

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 of Cambridge, MA., USA

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.