Senior Data Acquisition Specialist – Non-CRF

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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.

🏖️ 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.