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. 
 

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.