Clinical Trial Operations Opportunities at Parexel , Hyderabad, Telangana

Clinical Trial Operations Opportunities at Parexel , Hyderabad, Telangana

Job Purpose:

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.

Key Accountabilities:

Study Phase Accountability & Supporting Activities

may include but not limited to the following:

Start-Up Act as PAREXEL’s Data Surveillance Analysis expert

• Support the development of a robust Data Surveillance Plan, Quality Tolerance Limits and Data Surveillance technologies (Parexel Data Surveillance, CluePoints Statistical Analysis Platform, etc.)

• CluePoints:

o Create data import mapping for all data sources within CluePoints

o Create and set-up standard and bespoke KRIs

o Create and set-up Data Quality Assessment parameters

o Create KRI and DQA dashboards

Maintenance and close out Act as PAREXEL’s Data Surveillance Analyst, assess and review available study data to identify data quality trends, outliers, lack of variability, breeches of Quality Tolerance Limits, and other risks to study data quality and overall integrity

• Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.

• Recognize impact of study non-compliance/issues/delays/data quality signals and communicate/ promptly escalate to FL any site and/or study issues that require immediate action.

Overall Accountabilities from Site identification to Close out Ensure timely and accurate review of Data Surveillance tools, systems and reports

• Maintain a positive, results orientated work environment, building partnerships and collaborative relationships, communicating

Skills:

• Client-centric, quality focused approach to work.

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

• Excellent verbal and written communication skills, as well as experience in presenting at internal and sponsor meetings, conveying complex data and information in a clear, concise manner.

• Demonstrate basic understanding of SDTM domains and knowledge of data operations concepts.

• Demonstrate basic SAS programming skills.

• 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.

• Demonstrated working knowledge and practical application of functionality of Parexel and vendor technologies supporting centralized monitoring/data surveillance and Data Driven Monitoring.

Knowledge and Experience:

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

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

• Basic SAS programming and/or SQL script writing

Qualifications

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

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