TBD Lead Data Manager

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Clinical Data Manager (CDM) is responsible for all data management aspects of the assigned clinical studies from initiation till closure ensuring that clinical data completeness, accuracy and consistency meet the standards of quality for analysis and reporting to regulatory bodies, compliant with the local and global regulations.

The CDM will:

• Take a leadership role with the CRO, clinical study team and other internal and external partners to establish, align and conform data management expectations for the assigned trials.
• Set quality expectations and timelines for data management deliverables and will regularly follow up on data management milestones
• Ensure compliance with SOPs, company policies and regulatory requirements from trial start-up to trial close-out.

For the assigned trial(s) the CDM may be asked to:

• Participate in CRO selection and contract negotiations together with the argenx clinical study team and the Vendor Management representative
• Contribute to development of the protocol for the sections relevant for DM (feasibility of data collection, adherence to industry and argenx standards, (interim) locks) and/or review of protocol versions

For the assigned trial(s), the CDM will:

• Oversee all deliverables of activities outsourced to CROs as outlined in the SOW and described in the Data Management Trial Oversight plan, including, but not limited to:
• Creation of data collection tools (EDC, DTAs for 3rd party vendors, EDC integrations)
• Creation of essential documents (DMP, UAT documents)
• Creation of submission ready clinical data package per regulatory agencies requirements.
• Creation of archival package of clinical data per argenx requirements
• Oversee all activities related to Data Management:
• Ensure that Data Management essential documents are written in a timely manner and of such quality to allow the evaluation of the conduct of a trial and the quality of the data produced
• Facilitate cross-functional review by applicable stakeholders of essential documents and data management deliverables
• Keep track of project plan, budget, metrics and KPIs. Adjust project plan as needed in consultation with Data Management CRO and Clinical Team.
• Create Data Release Plan in consultation with applicable stakeholders and oversee Data Releases (such as for DSMB/IDMC, interim and final locks, updates after lock) as per plan and blinding rules.
• Participate in User Acceptance Testing Activities for the applicable Data Collection Tools
• Perform adequate Quality Control for data completeness and accuracy
• Contribute to the development in lessons learned and shares best practices within the trial and department.

The CDM will also participate in activities other than study-related:

• Lead/participate in initiatives on process improvements
• Participate in regulatory inspections and company audits

• Bachelor’s or Master’s Degree (Biology, Biomedical Sciences, Pharmacy, Mathematics, etc.) or equivalent experience
• Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM best practices
• Experience with tools and systems for managing clinical studies (study progress and metric systems, eCRF systems, metadata repositories)
• Eye for detail, analytical skills
• Able to work effectively within a team matrix as well as independently
• Strong communication and interpersonal skills
• Demonstrated experience in Clinical Data Management
• Experience in managing CROs and vendors
• Auto-immune and/or orphan disease clinical study background is a plus

Benefits of Working in ICON:

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.

At 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.

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, color, 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.