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Job Details

Data Surveillance Analyst

Company: PAREXEL
Location: , Vilnius County,Lithuania
Reference: 43542BR
Closing Date: 24 May 18
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

The role will be part of the Global Clinical Operations, acting as a Data Surveillance Analyst. The role will perform analysis of specific scientific and operational data to support the Data Surveillance process and will perform a central review of the defined project specific Quality Tolerance Limits. ...

Requirements:

The role will be part of the Global Clinical Operations, acting as a Data Surveillance Analyst. The role will perform analysis of specific scientific and operational data to support the Data Surveillance process and will perform a central review of the defined project specific Quality Tolerance Limits. The role will support the specific project functional roles with their DS Plan defined project reviews and any relevant findings will be communicated to the project team during the regular project specific Data Surveillance meetings. In addition, the role will support the development of the Data Surveillance Plan and participate in the Data Surveillance meetings.

Data Surveillance Analysts not only need to understand GCP and have a background in life sciences, but should also demonstrate fluency in statistical, analytical, and business skill sets in order to interpret risk (both qualitatively and quantitatively) and strategically support Data Surveillance activities. All reviews and analysis will be conducted as per the Data Surveillance Plan as aligned with Data Surveillance related processes, SOPs, ICH and/or other guidelines to fulfill local regulations.
Qualifications

Skills:

  • Demonstrated ability to review, analyze and understand and identify trends/outliers within large volumes of complex scientific or operational data.

  • Understanding of statistical, analytical methods used to conduct Data Surveillance.

  • Demonstrate basic understanding of SDTM domains and knowledge of Data Operations concepts.

  • Interpersonal skills that include the ability to build effectively within cross-functional project teams, ability to motivate others, delegation skills, drive to bring issues to resolution and timely/quality decision making.

  • Ability to triage quality issues and escalate serious quality findings or misconduct as per current SOPs.

  • Demonstrated understanding and experience with current PAREXEL Informatics technology.

  • Demonstrated ability to successfully manage a full workload diverse number of tasks across multiple-projects.

  • Excellent verbal and written communication skills (including experience in making presentations at meetings, and conveying complex data and topics).

  • Ability to work directly with sponsors (as required) as part of the Data Surveillance Team.

  • Client focused approach to work.

  • Ability to work in a matrix environment and contribute to the overall goals of HPC within project teams.

  • Comprehensive knowledge of relevant technology and PAREXEL processes

  • Excellent analytical and problem-solving skills

  • Client focused approach to work.

  • Flexible attitude with respect to work assignments and new learning.

  • Attention to detail.

  • Ability to manage multiple tasks, evaluate a variety of unpredictable scenarios, and achieve project timelines; apply understanding of study protocol(s).

  • Willingness to work in a matrix environment and to value the importance of teamwork.

  • Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.

  • Sound problem solving skills.

  • Sense of urgency in completing assigned tasks and ability to assist others to meet study deliverables.

  • Developing ability for effective time management in order to meet daily metrics, team objectives, and department goals.

  • Developing ability to work across cultures.

  • Able to work independently with regular oversight, seeking/taking guidance when necessary.

  • Shows commitment to and performs consistently high quality work.

  • Ability to successfully work in a (‘virtual’) team environment.


Knowledge and Experience:

  • 5 or more years of relevant medical, statistical, clinical or data management work experience recommended

  • Experience of working within a DDM study, and/or participating in the Data Surveillance process highly recommended.


Education:

  • Educated to a degree level (medical, biological science, pharmacy or other health related discipline preferred) or relevant clinical, technology or business equivalent

  • Advanced degree preferred, including MD, PhD, MSc

Apply for this job: Data Surveillance Analyst

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
England
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site
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