Clinical Data Laboratory Specialist
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29, 000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
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 our Total Self culture where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- 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 were able to create a place where everyone feels like they belong.
- 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)
What were 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%).
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, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. 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.
