Sr. Medical Reviewer Job at System One, Boston, MA

OUt6VW5yM1ZuSkZXZWtpYmpsM1VXZmEwZ1E9PQ==
  • System One
  • Boston, MA

Job Description

Title: Sr. Medical Reviewer 
Location: Remote with scheduled travel into Boston MA 
Schedule: Monday thru Friday 8-5pm est (over time as needed to meet deadlines) 
Duration : 12 months contracting 

Education
MBBS or  RN (licensed in MA)  or Physician Assistant (licensed MA)

Requirements:
Minimum 3 years of cardiovascular clinical and/or research experience including clinical endpoints or pharmacovigilance
Provide a medical review of event-specific dossiers to ensure completeness of the data to allow for adjudication by the physician adjudicators. 
Proficiency in MS Office products (Outlook, Word, Excel, and PowerPoint) and familiarity with databases 
Possess strong interpersonal skills to effectively communicate with cross functional teams including staff at all levels of the organization 

Ability to successfully negotiate and collaborate with others of different skill sets, backgrounds and levels within and external to the organization 

Requires minimal direction from leadership and possesses the ability to learn quickly

Responsibilities: 
Review event-specific dossiers to ensure completeness of the data to allow for adjudication by the physician adjudicators. 
Identify unredacted personally identifiable information and potential treatment unblinding information in the source and electronic case report form (eCRF) data provided. Notify the CEC Coordinators to redact any such information if identified. 

Review data changes and additional documents submitted for previously adjudicated events to determine if re-adjudication is required. 

Issue queries to the investigative sites for additional information or clarification of information provided. 

Participate in the trial-specific quality control (QC) process by reviewing discrepancies for summarizing and reporting to the CEC Chairman. 

Collaborate with the Sr. Project Manager and CEC Director to design the specifications for consistency/logic checks of the adjudication data, review outputs of the checks, and determine appropriate actions based on findings. 

Collaborate in the development of trial-specific procedures and work instructions and CEC standard operating procedures (SOPs). 

Serve as a resource for client's internal staff, Sponsor trial team members, Clinical Research Coordinators (CRCs), and trial Clinical Research Associates (CRAs) regarding the submission of source documents for CEC events. 

Job Tags

Contract work, Remote job, Monday to Friday,

Similar Jobs

Heal Pay

Junior Web Developer Job at Heal Pay

We create web applications to help businesses and consumers navigate taking and making payments online. We're looking for a productive developer with some experience to help us develop our products. You'll be using Rust, Ruby, Javascript, and PostgreSQL. We prioritize excellent... 

St. Anne's-Belfield School

Substitute Teacher Kindergarten - Grade 8 Job at St. Anne's-Belfield School

 ...'s-Belfield School is seeking a compassionate and dedicated Substitute Teacher to join our team, providing coverage for Kindergarten through...  ...or a related field preferred. Relevant coursework and/or experience working with children in an educational setting required.... 

Primark

Sales Coach - Primark Expansion (Apply in minutes) Job at Primark

 ...**What Youll Do** As a Team Leader, you will motivate and coach your team of Sales Associates toprovide an exceptional store environment...  ...customers in English andmonitor the performance of English-speaking colleagues whose job dutiesrequire communication with... 

All Med Search

Canadian Registered Nurses (RN's) needed for jobs in the USA Job at All Med Search

 ...QUALIFIED Healthcare Professionals accepted) Acute Care-RNs - Canadian RN (Registered Nurse) - Acute Care Expereince Preferred - TN Visa Sponsorship Available in Colorado, Lousiana, Missouri, Texas and more - EB3 Visa (Green Card) Sponsorship Available in many... 

CV Resources

Controller (Hiring Immediately) Job at CV Resources

 ...CV Resources is partnering with our client, a leading company in the consumer goods space, to help them find a Controller to add to their growing team. The organization is undergoing an exciting phase of growth, including an upcoming public offering , and they are...