Associate Data Manager

Were on a mission to change the future of
clinical research. At Perceptive we help the
biopharmaceutical industry bring medical
treatments to the market faster.
Our mission is to change the world
but to do this we need people like you.

Apart from job satisfaction we can offer you:

YOURSELF

Starting at 14 days holiday per year rising to 22 days with increased addition to public holidays

Life Events Service Awards Company Outings

HEALTH

Medical plan

Annual medical check

WEALTH

Social security and public housing fund

Supplementary Housing Allowance

Life assurance

Critical illness cover

Key Accountabilities:

Data Oversight
(Data Quality Assurance validation and linkage)

• Understand data governance and how it works in relation to other organizational governance structures.
• Understand basic data issues and can check that the data and analysis look right.
• Understand the concept of data being fit for purpose.
• Validate the collected data ensuring its accuracy and reliability.
• Assesses the integrity of data from multiple sources.
• Perform data preparation and cleansing with guidance.
• Apply ethical principles when handling data
  

Data Management

• Show an awareness of the need for careful analysis of different TAs data to produce clear findings.
• Participate in or deliver the assurance of a service.
• Show an awareness of industry-recognized data structures and standards (CDISC (SDTM) CDASH) and custom client specified formats.
• Serve as backup data management resource on a study.
• Contribute to the validation of data management programs and reports (data reconciliation data quality monitoring checks export reviewer metrics and custom reports).
• Review and action any data discrepancy or flags from data reconciliation data quality monitoring reports data exports and reviewer metrics.
• Understand the context of the data (awareness of Therapeutic Areas (TA) e.g. oncology cns ophthalmology volumetrics etc.) and how data differs based on the specific criteria (RECIST 1.1 irRECIST mRECIT Lugano Cheson etc.)
  

Data Operations

• Provide reports to business based on function or project requirements developed by the programmers (on schedule of ad hoc).
• Support business stakeholders in generation of reports to support efficient business process and outlier reviews
  

Documentation

• Document evidence of data findings following internal SOPs and best practices
• Participate in the review of different DM documents like data reconciliation and analytics export requirement specification data management plan software change requests.
• Understand protocol and charter.
  

Communication

• Show an awareness of the need to translate technical concepts into non-technical language.
• Understand what communication is required with internal and external stakeholders.
• Clearly and timely communicates any data findings within internal team
  

Logical and creative thinking

• Identify problems in databases data processes data products and services with an understanding of the level of a problem (for example strategic tactical or operational)
• Contribute to the implementation of remedies and preventative measures.
  

Technical

• Ability to run programs created using SAS Python PL/SQL or R
• Ability to create small PL/SQL queries or Excel macros to support efficient data validation

Other

• Carryout any other reasonable duties as requested.
• Ability to prioritize tasks or raise potential issues with deliverable on time

Skills:

• Proficiency in data collection cleaning validation and database management techniques within the clinical research context.
• Strong analytical and problem-solving skills to identify issues and propose solutions.
• Understanding of the requirements (data reconciliation data quality monitoring data exports) and how to translate them in quality checks to ensure data integrity.
• Ability to perform data quality checks resolve discrepancies and ensure data integrity throughout the study.
• Ability to manage multiple tasks and prioritize work in a fast-paced and deadline-driven environment.
• Understanding of clinical trial processes protocols and regulatory requirements (e.g. FDA guidelines) related to data management.
• Meticulous attention to detail documentation and adherence to study protocols and standard operation procedures (SOPs)
• Excellent communication (oral and written) and interpersonal skills to convey data-related information to technical and non-technical stakeholders.
• Evidence of ability to work collaboratively within a matrix team environment.

Knowledge and Experience:

• Prior experience in clinical data management or a related role within the pharmaceutical biotechnology or CRO industry preferred
• Strong analytical skills with attention to detail and the ability to identify data discrepancies and trends.
• Knowledge of regulatory guidelines and requirements for clinical data management (e.g. 21 CFR Part 11 GCP).
• Proficiency in Microsoft Office Suite (Word Excel (macros) PowerPoint) and data visualization tools is preferred.
• Familiarity with clinical trial data standards (e.g. CDISC CDASH)
• Familiarity with data management and analysis software and tools (e.g. Oracle Clinical Medidata Rave OpenClinica).
• Experience working in cross-functional teams with Clinical Operations Scientific and Medical Affairs and other stakeholders involved in clinical trials.
• Understanding of different therapeutic areas like oncology cns ophthalmology etc. and different criteria like RECIST 1.1 irRECIST mRECIST Cheson Lugano etc is a plus.

Education:

• Bachelors degree in Life Sciences Computer Science Engineering or a related field
• Masters degree is a plus.
• English: Fluent

Come as you are.
Were proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race religion colour national origin gender (including pregnancy childbirth or related medical conditions) sexual orientation gender identity gender expression age status as a protected veteran status as an individual with a disability or other applicable legally protected characteristics.