Project Manager Data Management

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.

Primary Responsibilities

• Serves as the primary contact for internal and external team members regarding data management activities.
• Authors documents such as interim lock plans, database closure plans, and database unlocking plans.
• Tracks milestones, tasks, and the overall budget for assigned projects.
• Participates in sponsor and/or third-party audits.
• Forecasts units, hours, and resourcing for data management tasks.
• Develops plans and oversees timeliness for activities between the last patient visit and the database lock.
• Contributes to bid and proposal development and participates in bid defense meetings.

Level-Specific Responsibilities

• Takes a lead role in PRA and data management initiatives.
• Responsible for owning and achieving interim and final contractual deliverables for assigned projects.
• Ensures quality-control steps are implemented so that quality deliverables are provided.
• Mentors and trains other data management team members.
• Writes articles for industry publication and gives presentations at industry conferences.
• May act as portfolio-level data manager as necessary across projects with lead data managers assigned.

Skills:

• Manage all operational aspects of clinical trials in compliance with GCP regulations, PRAHS policy and Client Company policy.
• Manage project and timelines across Client programs and studies.
• Ensure timeliness of deliverables for each phase of the study from study start-up through production and close-out activities.
• Interact with various Data Management and other functional area colleagues, including, but not limited to: Biostatistics and Programming, Clinical, Safety, Medical Coding, site personnel.
• Ensure Clinical Data Management staff maintains all relevant documentation associated with each assigned Protocol.
• Identify and work collaboratively and cross-functionally to implement process improvement measures within data management on both departmental and project level.
• Coordinate with Clinical Data Management Staff, Client, and Study Team to identify issues/trends for discussion.
• Lead study/project team meetings as primary facilitator of timelines, providing updates on study status to the cross functional team.
• Escalate any potential or actual issues in a timely manner and follow issues through to resolution.
• Contribute to the development and/or revision of Clinical Data Management SOPs and related documentation.
• Serve as primary point of contact for all project timeline related communication.
• Monitor and work to maintain/improve stakeholder satisfaction by ensuring high quality service, communication, and management of clinical data.
• Lead and facilitate all project team meetings.

• Bachelor’s degree in Health or Life Sciences
• 4 to 5 years of previous clinical research or data management experience 
• Advanced level of English

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.