Senior Data Acquisition Specialist

Why Syneos Health

• #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

This role will specialist in Data Acquisition/ 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
• Implement/maintain non CRF checks that ensure structural data quality, conformance to established format specifications
• Receive, process, and deliver non CRF test and production data
• Provide effective partnership and communication with project (study) and non-project stakeholders, both internal (study team, CDM peers, functional business partners) and external (data suppliers/vendors): discussion of study needs, expectations, issue management, innovation, continuous improvement, troubleshooting
• Participate in Non CRF Data Functional initiatives
• May perform data reconciliation (CRF vs. non) or sample reconciliation.
• Provide comprehensive assessment to identify all non CRF data types defined in the study protocol via protocol review and team discussion (including amendments)
• Aware of patient enrollment and randomization strategy and responsible for set up of IXRS UAT
• Implement, maintain and approve non CRF Vendor Transfer Agreements/plans/ specifications
• Implement/maintain non CRF checks that ensure structural data quality, conformance to established format specifications
• Receive, process, and deliver non CRF test and production data
• Provide effective partnership and communication with project (study) and non-project stakeholders, both internal (study team, CDM peers, functional business partners) and external (data suppliers/vendors): discussion of study needs, expectations, issue management, innovation, continuous improvement, troubleshooting
• May perform data reconciliation (CRF vs. Non) or sample reconciliation.
• Adhere to non CRF standards
• Timeline- aware of study timeline and responsible for making sure non CRF task is completed within timeline with agreement of all stakeholders
• May perform Alert lab range entry
• May perform QC of conformance checks and Vendor transfer agreement
• May provide process training and mentoring
• May participate in Non CRF Data Functional initiatives
• May serve in functional SME (Subject Matter Expert) roles within company or with sponsor.

Qualifications

What we’re looking for

• BA/BS degree in the biological sciences or related disciplines in the natural science/health care field.
• 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.
• Responsible for performing activities that are in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management. Minimal travel may be required (up to 25%).

Get to know Syneos Health

We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

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.