Project Data Management, Data Acquisition Specialist

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🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

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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

• Responsible for project management of all the data management services for the assigned projects • Ensures the contracted Non CRF Data Management activities for projects are carried out by the Company in accordance with the executed contract and the Sponsor’s expectations • Acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups • Coordinate the work of the assigned Data Management/Data Operations team • Communicate independently, proactively and clearly to internal and external stakeholders, able to work autonomously on the non-CRF data strategy for the study team • Take ownership of non-CRF data • Provide comprehensive assessment to identify all non CRF data types defined in the study protocol via protocol review and team discussion (including amendments) • Support implementation of patient enrollment and randomization strategy responsible for set up of IXRS UAT • Implement, maintain and approve non CRF Vendor Transfer Agreements/plans/ specifications • Confirm non CRF vendor specifications can be met and provide expertise on testing/results • Effectively communicates non-CRF data collection deliverables, status of work and data issues to the Client study lead and other study team members • Coordinates cross-functional non-CRF tasks with strong understanding of downstream processes and stakeholder needs and impacts • Receive, process, and deliver non CRF test and production data • Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations • Provides project specific training to internal and external audiences as required • Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed • Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management • Plan, manages and requests resources for assigned projects • Develop and maintain project plans, specifications and documentation in line with SOP requirements • Maintains documentation on an ongoing basis and ensures that all TMF filing is complete and up to date • Participates in, and presents at internal, Sponsor, third-party, and investigator meetings • Plans for and creates necessary documentation to support internal and external audits; participates in such audits • Trains and mentors data management staff • Prepares input for, and participates in proposal bid defense meetings • Maintains proficiency in Data Management systems and processes through regular training • Performs other work related duties as assigned

🎯 Requirements

• BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse • Must have 8+ years of experience in Clinical Data Management • Must have 3-4 experience into external vendor data setup and non-CRF setup activities • Must have experience in DTS (Data Transfer Specification), DTA (Data Transfer Agreement), FFS (File format specifications) • Experience into eCOA, ePRO, patient diaries, Device testing, sensor testing, Data transfer agreement, external data setup, Lab, ECG, IWRS/IVRS testing • Experience of Clinical Data Management practices and relational database management software systems • Strong project management skills and knowledge of project management methodologies • Demonstrated staff leadership skills • Contract Research Organization (CRO) experience preferred • Direct exposure to Oracle Clinical, Rave, or Inform systems • Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications • Effective oral and written communication skills • Strong presentation skills • Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail • Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team • Ability to make effective decisions and manage multiple priorities in a highly dynamic environment

🏖️ 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