Sr. CEC Medical Reviewer

7 days ago


Cambridge, United States Joulé Full time
Title: Sr. CEC Medical Reviewer

Find out more about this role by reading the information below, then apply to be considered.
Clinical Events Committee (CEC)
Location: Boston MA Local Hybrid
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.

  • Cambridge, United States Joulé Full time

    Title: CEC Clinical Trial CoordinatorEnsure all your application information is up to date and in order before applying for this opportunity. Location: Boston MA Schedule: Monday through Friday (local hybrid) Duration: contract to hire Education: Bachelor’s degree Requirements: Proficiency in MS Office products (Outlook, Word, Excel, and PowerPoint)...


  • Cambridge, United States JM Chandler Dream Builders Full time

    If you post this job on a job board please do not use company name or salary. Experience level: Midsenior Experience required: 5 Years Education level: Bachelors degree Job function: Engineering Industry: Consumer Electronics Pay rate : View hourly payrate Total position: 1 Relocation assistance: No Visa sponsorship eligibility: NoWork Hours Per Week: 35 ...

  • Sr. Project Manager

    4 weeks ago


    Cambridge, United States GCR Professional Services Full time

    Sr Project Manager Contract 40 hours weekly 6-12+ months Onsite, US Citizen ONLY Active Security Clearance PROJECT MANAGEMENT - SUMMARY The Sr. Project Manager position will be responsible for managing the deployment of multiple classified networks across multiple client campuses. This role will also be responsible for the management of and coordination...


  • Cambridge, United States Innova Solutions Full time

    Innova Solutions Client is immediately hiring for a Manager/Sr Manager, Data Management Position type: Full Time Perm Location: Preferred location Cambridge, MA / Remote Salary: $175K - $185K depending on experience and level, might go up on the salary for the right candidate As a Manager/Sr Manager, Data Management you will: RESPONSIBILITIES Manage and...


  • Cambridge, United States Proclinical Staffing Full time

    (Sr.) Director, Clinical Operations - Permanent - Cambridge, RemoteProclinical is working alongside a biotech company seeking a (Sr.) Director, Clinical Operations to lead and manage clinical trials within early-stage programs. This role focuses on overseeing studies from startup to completion, ensuring operational excellence, and contributing to study...


  • Cambridge, United States Proclinical Staffing Full time

    (Sr.) Director, Clinical Operations - Permanent - Cambridge, RemoteProclinical is working alongside a biotech company seeking a (Sr.) Director, Clinical Operations to lead and manage clinical trials within early-stage programs. This role focuses on overseeing studies from startup to completion, ensuring operational excellence, and contributing to study...

  • Sr. CRA

    3 weeks ago


    Cambridge, United States ICON Strategic Solutions Full time

    Requires 5+ years of experienceEUMDR is preferred The Clinical Research Associate (CRA) - will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements....

  • Sr. CRA

    3 weeks ago


    Cambridge, United States ICON Strategic Solutions Full time

    Requires 5+ years of experienceEUMDR is preferred The Clinical Research Associate (CRA) - will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements....


  • Cambridge, United States Capital One Full time

    Center 3 (19075), United States of America, McLean, VirginiaSr. Director, Data EngineeringCapital One is seeking a Sr. Director of Data Engineering to work in our Enterprise Data organization. This individual will specifically be leading teams delivering and expanding highly performant and scalable data products and platforms to drive consumption of data...


  • cambridge, United States Softworld, a Kelly Company Full time

    Job Title: Sr Principal Network EngineerJob Location: San Diego MD 92123 Onsite Requirements:IP4 and IPv6 network designNetwork design and architectureActive U.S. Government DOD Secret ClearanceJob Description: As a Sr Principal Network Engineer. You will have a challenging and rewarding opportunity to be a part of our Enterprise-wide digital...


  • Cambridge, United States Experis Full time

    Project Manager 3+ months Cambridge MA Within the Global Medical Immunology team, we are proud to support unrelenting commitment to scientific exploration and to work on dupilumab in the therapeutic area(s) of dermatology, pulmonology, rhinology, or gastrointestinal diseases. Main responsibilities: Reporting to the Global Scientific Director, this key role...


  • Cambridge, United States KLM Careers Full time

    Medical Device Senior Manufacturing Engineer Cambridge MA Must be a US Citizen or Green Card holder. This is a 6 month contract NO C2C. The hiring manager is specifically seeking candidates with handson experience in cart systems console operations and electromechanical devices. When sourcing candidates please prioritize those who have demonstrated...


  • cambridge, United States Pyramid Consulting, Inc Full time

    Immediate need for a talented Senior Scientific Medical Communications/ Project Manager. This is a 03+ Months Contract opportunity with long-term potential and is located in Cambridge, MA or Bridgewater, NJ(Hybrid). Please review the job description below and contact me ASAP if you are interested.Job ID:24-45742Pay Range: $70 - $80/hour. Employee benefits...


  • Cambridge, United States Pyramid Consulting, Inc Full time

    Immediate need for a talented Senior Scientific Medical Communications/ Project Manager. This is a 03+ Months Contract opportunity with long-term potential and is located in Cambridge, MA or Bridgewater, NJ(Hybrid). Please review the job description below and contact me ASAP if you are interested.Job ID:24-45742Pay Range: $70 - $80/hour. Employee benefits...


  • Cambridge, United States Pyramid Consulting, Inc Full time

    Immediate need for a talented Senior Scientific Medical Communications/ Project Manager. This is a 03+ Months Contract opportunity with long-term potential and is located in Cambridge, MA or Bridgewater, NJ(Hybrid). Please review the job description below and contact me ASAP if you are interested.Job ID:24-45742Pay Range: $70 - $80/hour. Employee benefits...


  • Cambridge, United States PostJobMatches By WorkStaff USA Staffing Agency LLC Full time

    PostJobMatches By WorkStaff USA is a leading staffing agency in the job placement industry providing topnotch professionals to facilities across the country. Our team of experienced recruiters work together to match the best candidates with the right job and/or business opportunities. Today we are seeking a Medical Device Senior Manufacturing Engineer...

  • Sr Corrections

    2 days ago


    Cambridge, United States Philips International Full time

    Sr Corrections & Removals Specialist Job Title Sr Corrections & Removals Specialist Job Description As an experienced medical device quality assurance professional, you will be performing various Corrections and Removal functions related to recall management, including: planning, reporting, tracking, record keeping, and other QMS adjacent tasks as required....


  • Cambridge, United States LifeMine Full time

    Why join us? LifeMine is a biopharmaceutical company pioneering Top-Down Drug Discovery, a bold new approach that leverages evolutionary insights from fungi to unearth next-generation precision medicines. Through our data-immersive and technologically expansive discovery engine, we are uniquely positioned to bring mechanistically and structurally novel...


  • Cambridge, United States LifeMine Full time

    Why join us? LifeMine is a biopharmaceutical company pioneering Top-Down Drug Discovery, a bold new approach that leverages evolutionary insights from fungi to unearth next-generation precision medicines. Through our data-immersive and technologically expansive discovery engine, we are uniquely positioned to bring mechanistically and structurally novel...


  • cambridge, United States Proclinical Staffing Full time

    (Sr.) Director, Clinical Operations - Permanent - Cambridge, RemoteProclinical is working alongside a biotech company seeking a (Sr.) Director, Clinical Operations to lead and manage clinical trials within early-stage programs. This role focuses on overseeing studies from startup to completion, ensuring operational excellence, and contributing to study...