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Senior Data Acquisition Specialist – Non-CRF
Syneos HealthLead Clinical Data Associates managing data acquisition activities during global clinical trials. Oversee data management, quality checks, and support for project data manager.
Tech Stack
Tools & technologiesOracle
About the role
Key responsibilities & impact- 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
What you’ll need- 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.
Benefits
Comp & perks- 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.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Clinical Database ManagementData Management PracticesRelational Database Management SoftwareData Cleaning ReportsMedical TerminologyData Transfer AgreementDevice TestingSensor TestingDiscrepancy ReviewData Entry Accuracy
Soft Skills
Excellent Communication SkillsInterpersonal SkillsOrganizational SkillsTime Management SkillsAbility to Multitask