Manager, Clinical Operations
Apply NowCompany: Spectranetics
Location: Cambridge, MA 02139
Description:
Job Title
Manager, Clinical Operations
Job Description
Clinical Operations Manager (Cambridge, MA)
An opportunity to be a part of business-critical projects within the Hospital Patient Monitoring Clinical Operations team- Providing leadership in execution of clinical studies to deliver high quality data on time, within budget and in compliance to all applicable regulations and Philips procedures.
Your role:
You're the right fit if:
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.
Philips Transparency Details
The pay range for this position in (Cambridge, MA) is $113,400 to $181,440
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.
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.
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 to Cambridge, MA.
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.
Manager, Clinical Operations
Job Description
Clinical Operations Manager (Cambridge, MA)
An opportunity to be a part of business-critical projects within the Hospital Patient Monitoring Clinical Operations team- Providing leadership in execution of clinical studies to deliver high quality data on time, within budget and in compliance to all applicable regulations and Philips procedures.
Your role:
- Part of the Clinical Operations Team within Clinical and Medical Affairs. This team Study execution and deliverables across Philips's Hospital Patient Monitoring (HPM) under the Monitoring Business.
- Protocol Development (PD)
- Data Capture Development Tool (DCDT), Case Report Forms, source documents, survey building, knowledge of data transfer and ePro functionality
- Site start up to Site Activation (SA) to include budget/ contracts/ legal/ privacy and site selection.
- Study execution, site management/enrollment engagement/ metric tracking / SIV presentations/ GCP training/EDC and Safety discussion
- Database lock to include listing review/ query resolution/ timeline creations.
- Clinical study reporting: tables/listings/graphs/data analysis/ trending and reporting
- Coaching/ Mentoring Jr. staff members
You're the right fit if:
- You've acquired 8+ years of experience in execution and management of clinical trials and / or clinical research experience in the medical device industry.
- Your skills include knowledge in Electronic Data Capture systems (EDC), GCP /ISO14155 working knowledge, eTMF experience, experience working with cross-functional teams, working knowledge of IRB expectations/ correspondence, and familiarity with Clinical trial management systems (CTMS)and timeline driven tools.
- Post Market Follow Up experience preferred
- You have a bachelor's degree in a relevant field of study
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
- You work well in a team environment and perform well in a global cross-functional team.
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 culture.
Philips Transparency Details
The pay range for this position in (Cambridge, MA) is $113,400 to $181,440
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.
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.
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 to Cambridge, MA.
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.