Biometrics Project Associate

As a Biometrics Project Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

Position Summary

The Clinical Data Associate (CDA) I supports lead Clinical Data Management members while developing data management skills and may lead aspects of a study with a high degree of support and oversight. The CDA I may have a dedicated support role within CDM, specializing in a subset of the responsibilities below.

Principal Responsibilities

• Support lead CDAs with DM deliverables including, but not limited to, Data Management Plans, CRFs, CRF Completion Guidelines, Edit Checks, UAT and Data Review Plans. Utilize templates and standard guidelines to initiate documents but exercise critical thinking and discretion to tailor documents to study needs.
• With oversight, may lead the data management aspects of a clinical study, including collaboration and relationship-building with all study team representatives (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics scientists, Medical Writers, Regulatory representatives, etc.).
• Run SAS programs, review SAS logs, and generate output in order to perform data reconciliation outside of the EDC system. Research and resolve data discrepancies of moderate complexity.
• Support data cleaning activites such as, but not limited to, study team data reviews, generation

of data listings, SAE reconciliation, non-CRF data reconciliation and generating/posting queries. Exercise discretion and seek guidance to choose efficient and effective issues resolution paths.

• Assist lead CDAs with data deliverables and database lock procedures, executing on operating procedures, timelines and guidelines with quality and efficiency.
• Support eTMF health and integrity by overseeing uploads, managing metadata, performing QC

and oversight tasks.

• Manage user access across various CDM systems
• Understand rationale and purpose of medical coding.
• Assist in maintenance of department tools, templates, guidelines, SOPs, and systems.
• Assist lead CDA in working w/ vendors/CROs and support the development of Data Transfer

Plans.

• DM Project Management: Develop working knowledge of overall data management activities;

assist with project management for lead CDAs.

• Demonstrate "everyday leader" qualities.

You are:

Qualifications

• Years of experience: Typically 1+ years of related experience.
• Effective organizational and communication skills.
• Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and profession.
• Detail oriented; performs quality and accurate work.
• Thorough knowledge of FDA regulations and ICH GCP guidelines and the DM Lifecycle; Subject matter expertise may substitute for broader DM lifecycle knowledge.
• Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively.
• Preferred:

o Previous experience with RTSM/IWRS and ePRO systems

o Knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, the drug development process

o Previous relevant EDC experience

o Previous vendor/CRO management

o Oncology experience and/or working knowledge

Education

• BA/BS in relevant field. Years of experience may substitute for education.

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.