Senior Clinical Data Science Lead

As a Senior Clinical Data Science Lead - Data Management you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Clinical Data Management Expertise. Oversees and coordinates Data Management activities across one or more clinical trials. Develop and maintain successful working relationships with internal team and internal and external stakeholders to ensure and maintain data integrity and quality. Services rendered will adhere to applicable Client SOPs, WIs, policies, local regulatory requirements, etc

Deliverables:

BASE

• Provides data management support, oversight and/or accountability for one or more clinical trials.
• May take a leadership role with the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s).
• With the trial customer and other functional partners: – Gathers content and integration requirements for eCRF and other data collection tools. – Establishes conventions and quality expectations for clinical data. – Establishes expectations for dataset content and structure. – Set timelines and follow-up regularly to ensure delivery of all Data Management milestones.
• Performs trial level oversight controls, as appropriate, as described in the oversight plan, QC process and work instructions with minimal DML direction.
• Creates  clinical  data  management  documents  (including  submission  package)  ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
• Ensures real-time inspection readiness of all Data Management deliverables for the trial; Participate in Regulatory Agency and Client’s internal audits, as necessary.
• Helps  plan,  create  and  track  content,  format,  quality,  and  timing  of  data  management deliverables, including, but not limited to, Case Report Form, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival.
• Ensures deliverables are on time.
• Participates in the assigned clinical working group(s) to ensure that Data Management and
• Therapeutic Area trial needs and deliverables are met.
• Helps  Identify  and  communicate  lessons  learned,  best  practices  and  frequently  asked questions at the trial level.
• Presents and trains at investigator and monitor meetings, if needed.

ADVANCED (level 2, in addition to base):

Takes a leadership role in creating, planning, and tracking content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensures deliverables are on time.Takes a leadership role  with the assigned clinical  working  group(s) to ensure  that  Data Management and TA trial needs and deliverables are met. Takes a leadership role in Identifying and communicating lessons learned, best practices and frequently asked questions at the trial level

Education and Experience Guidelines:

• Bachelor’s degree in Health or Science discipline with experience in clinical research.
• Data Management experience preferred / required for based and advanced level
• Experience working on a clinical trial.
• Experience working in highly diverse teams within clinical research; cross-functional, global, multi- regional.
• Project management skills.
• Vendor management skills.
• Advanced Microsoft Office skills including the ability to manipulate and analyze data.
• Highly organized with excellent written and verbal communication.
• Ability to interpret clinical trial data and present trends to clinical trial team on data.

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.