Commercial Project Manager 1

Description

Intake call notes: See Commercial Title: Clinical Evaluations Manager

Position Details

• Role: Senior Clinical Evaluations Manager (Gap Coverage)
• Duration: Until end of February 2025
• Location: Remote (normal working hours)
• Travel: No
  
  

Requirements

• Experience: 3-5 years in clinical evaluations, medical physics, or related field
• Skills:
• Must-Have:
  
  

 Experience managing the entire Clinical Evaluation Report (CER) process

 Oncology background with medical devices

 Cross-functional leadership and communication

 Regulatory awareness (EU MDR and FDA clinical evidence and evaluations)

• Nice-to-Have:
  
  

 Experience with medical software devices

 Project management and EU clinical evaluation experience, especially with radiation oncology devices

Hiring Process

• Urgency: Immediate hire needed
• Interview Process:
• 1st round: Initial screening
• 2nd round: Follow-up panel interview
  
  

Compensation

Additional Information

• Work Hours: standard hours in their time zones
• Location: Remote position, based anywhere in North America
• Additional Skills: Ability to jump into clinical revision reports for regulatory purposes, CRE experience with software devices
  
  

Responsibilities

This is a role well suited for a self-driven professional looking to expand the impact of Medical Affairs work across the organization. As a Clinical Evaluations Manager, you will be responsible for:

• Creation of Clinical Evaluation Plans, Reports, and Post-Market Clinical Evaluation Plans, and Reports (CEP/CER and PMCFP/PMCFR)
• Providing clinical perspective and input to cross-functional teams such as risk management, product management, and post-market surveillance
• Execute Post-Market Clinical Follow Up activities (may include customer surveys, annual literature searches, clinical studies)
• Provide clinical review of promotional material and claims in support of publishing customer facing content
  
  

Skills

This position may suit you best if you are familiar with what is below, and would like to develop your skills with Healthineers:

• You have familiarity with design and manufacture medical devices, especially those used in the radiation oncology setting
• You have exemplary technical writing and verbal communication skills
• You prefer an autonomous working environment, as this position is remote.
  
  

Required skills and education to have for the success of this role

• Understanding of Clinical Evaluation and Post Market Clinical Follow Up Requirements of class I-III medical devices as designated in the European Union Medical Device Regulation (EU MDR)
• Master’s or PhD in Medical Physics (preferred), Biophysics, Biomedical Engineering. Other degree programs considered based on experience
• 3-5 years’ experience with clinical evaluations, medical physics, or related field.
  
  

At Client, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

Vaccination Notice

Additional Details

• Biological/Chemical Scientist/Engineer 4|NY
• Does this worker qualify for overtime? : Yes
• Scorecard Category : Professional
• Commercial Title : Clinical Evaluations Manager
• Vaccination Notice : This position requires Contingent Workers to be fully vaccinated against COVID-19 unless they are granted a medical or religious exemption.
• Is this position for a pre-identified (PAYROLLED) candidate? : RECRUITED
• If this is a pre-identified (PAYROLLED) candidate, please see note below and provide the following: : Name: Email Address: Phone Number: Pay Rate: Please also attach the pre-identified candidate's resume
• Will this contingent worker require a computer or systems access or utilize a timeclock? : Yes
• Time System : Fieldglass
• Timeclock/Shift : Fieldglass|1
• Enter Shift Start and End Time : 8:00 am to 4:00pm
• Is there potential for this to convert to a full time position? : Yes
• Non-Employee Class : Temporary Agency Worker
• Will the worker be required to travel for Client? : No
• Is there potential for this assignment to be extended beyond 13 weeks? : Yes
• Type of assignment : Full-time
• Healthineers Vaccination Statement : Healthineers positions within applicable states require candidates to be fully vaccinated or obtain approval of special medical or religious exemption within three days of worker start date.Currently not applicable in the following states: Alabama, Florida, Iowa, Kansas, Montana, North Dakota, Tennessee, Texas, and Utah. States subject to change