Senior Data Acquisition Specialist – Non-CRF

Role Overview

• This position is responsible for leading other Clinical Data Associates (CDA) in collection of Non-CRF data/data management activities, during study set-up, conduct and closeout activities for multiple studies, providing support and may function as a backup for the Project Data Manager (PDM).
• Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager (PM) and/or Biometrics Project Manager (BPM) as necessary.
• Reviews and adheres to the requirements of study-specific DMP for assigned project(s) and updates as required.
• Creates and enters test data for User Acceptance Testing (UAT).
• Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings.
• Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets.
• Performs reviews of discrepancy output and validation listings based on data entered into the clinical database.
• Resolves answered queries and re-queries where appropriate.
• Ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects.
• Participates/Leads in internal meetings and attends in-process review meetings.
• Creates ad-hoc data cleaning reports used to determine if a validated listing is required including creation of the specification for the validated listing.
• Trains and mentors DM staff providing timely feedback to trainee and management as appropriate.

Requirements

• BA/BS degree in the biological sciences or related disciplines in the natural science/health care field.
• Must have 5 to 7 years of experience in Clinical Data Management.
• Must have experience into external vendor data setup and non-CRF setup activities.
• Must have experience in central lab.
• Experience into eCOA, ePRO, patient diaries, Device testing, sensor testing, Data transfer agreement, external data setup, Lab, ECG, IWRS/IVRS testing.
• Experience with DM practices and relational database management software systems preferred. Oracle Clinical, Rave, or Inform systems preferred.
• Knowledge of clinical data, and ICH/Good Clinical Practices.
• Knowledge of medical terminology preferred.
• Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and email applications.
• Excellent speed and accuracy of keyboard skills.
• Work experience in clinical research, drug development, data management, or other healthcare environment preferred.
• Familiarity with medical terminology.
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Good organizational, planning, and time management skills preferred.
• Ability to multitask under tight deadlines while providing attention to detail.
• Ability to be flexible and adapt to change.
• Ability to work independently as well as part of a multi-disciplinary team.
• Ability to perform leadership functions in DM including effective mentoring skills, and the ability to deal effectively with sponsors and internal customers.

Tech Stack

• Oracle

Benefits

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.