Clinical Data Lab Specialist at Syneos Health Clinical Solutions

Description
 
Clinical Data Laboratory Specialist 

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of. 
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

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 

•     Review of the central LNR database to assess the availability of the local laboratories being used on a project. Communicate with the project team to obtain LNRs not available in the central LNR database. 
•     Transcription of the raw local lab range information provided by the site monitor into the LNR database (if not available) 
•     QC of the LNR data entered into the central LNR database 
•     Provision of the protocol-specific LNR output for each relevant site for entry into EDC
•     Raise queries regarding local laboratory range data to the local laboratory staff in order to resolve issues 
•     Undertake QC of the local laboratory normal range data output, prior to entry into EDC
•     Liaise with the Clinical Data Management team regarding the provision of the project-specific local laboratory range data
•     Input data into the Clinical Laboratory Data tracking database and ensure accuracy of information  
•     Provision of metrics to project teams regarding the status of project local laboratory range data to ensure timely collection and validation of data
•     Resolution of local lab ranges/unit conversion issues with Biostatistics and Medic as required
•     May support entry of the site-specific local laboratory normal ranges into EDC
•     May undertake QC of the entry of the site-specific local laboratory normal ranges into EDC by DM
•     Participates in internal audits as required
•     May provide clinical laboratory training to CDLS and project team members
•     Serves as a clinical laboratory data Subject Matter Expert (SME) 

 
Qualifications
 
What we’re looking for

•     BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. B.Tech or N.Dip Biomedical Technology preferred where applicable in lieu of degree, equivalent relevant work experience  
•     Clinical Data Management experience with particular experience of handling local laboratory data
•     Experience with local laboratory data collection methods and management of local laboratory range data in clinical trials
•     Understanding of laboratory analytes, their unit of measurement and associated normal and abnormal ranges for overall safety management of patients in clinical trials
•     Knowledge of medical terminology 
•     Contract Research Organization (CRO) experience preferred
•     Good communication skills
•     Good organizational, planning, and time management skills preferred. Ability to multitask under tight deadlines while providing attention to detail
•     Able to demonstrate critical thinking with strong attention to detail 
•     Knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management and local laboratory data management
•     Ability to deal effectively with internal customers
•     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.