Project Data Management (Data Acquisition Specialist-Non-CRF)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• 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. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

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. Minimal travel may be required (up to 25%)

• BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience.

• 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 Data management startup, study setup.

• 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.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.