ICON Strategic Solutions Senior Principal Clinical Data Standards Consultant in Topeka, Kansas
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.
Description of Role & Responsibilities
The Program Manager oversees the projects and or activities within Global Clinical Data Standards (GCDS) purview and the associated clinical information governance network in collaboration with the Director of Operations, GCDS. They monitor, track, and control outcomes to resolve issues, conflicts, dependencies, and critical path deliverables using a consistent project management methodology. Through teamwork and a data driven approach, they would work analytically and creatively to solve problems. Coordinates Merck’s standards governance network and facilitates Merck participating in and connecting with external standards related activities (e.g., CDISC, PhUSE, TransCelerate). Manages the definition, implementation, and maintenance of GCDS Standard Operating Procedures and supporting documentation to ensure compliance with worldwide regulatory and relevant internal Merck requirements.
Primary activities include, but are not limited to:
Ensure individual projects are completed on time, within budget, and in alignment with company goals (projects will have set timeframes).
Prepare and manage project materials, including a project plan, RACI, meeting materials (e.g., notes, decision log, action items, etc.), timeline, kick-offs, retrospective reviews.
Establish appropriate metrics to track and monitor progress and quality (as necessary).
Bring together team members.
Communication with and motivation of stakeholders.
Addressing pain points, risks, and maintaining quality control.
Prepare and maintain project status reports.
Ability to organize and run meetings efficiently.
Ability to show critical thinking and a “think-on-your-feet” mindset.
Lead/participate in cross-functional data governance reviews and projects.
Lead/participate in departmental and/or cross-functional working groups and process improvement initiatives. Represents function in cross-functional project teams; establishes collaborations/interactions with colleagues outside the department and makes frequent contacts external to the area and/or company.
Maintain knowledge of new technologies, clinical information industry standards, regulatory requirements, and Merck guidelines and SOPs.
Define and oversee implementation of a standards communication plan.
Able to work independently or as a team member or leader with equal effectiveness. Interacts with staff across multiple Merck sites.
Mentors, guides, and provides project leadership for junior staff as assigned.
Minimum FTE Years of Experience
Experience: 7+ years of work experience, which includes 5 years of program management experience.
Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in managing multiple projects.
Strong knowledge of the Drug Discovery Process, ICH and GCP guidelines
Proven ability to work collaboratively on interdisciplinary teams.
Strong interpersonal skills that demonstrate initiative and motivation.
Proven ability to solve complex problems.
Strong skills in project management
Ability to effectively organize and manage multiple assignments with challenging timelines.
Ability to mentor cross functional colleagues in data standards and metadata management practices.
Broad knowledge of and experience with clinical development & data management processes and regulatory requirements
Extensive program and/or project management experience managing and governing clinical information standards activities.
Awareness of industry standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, and HL7) and submission deliverables (SDRG, ADRG, Define.xml).
Must have awareness of project management methodologies (e.g., Scrum, Agile, Waterfall) and tool.
Experience in defining, implementing, and managing process improvement projects and documentation.
A broad comprehensive knowledge of the clinical trial process including data management (data collection, processing, storage, and retrieval), requirements gathering, and worldwide regulatory data management and reporting requirements.
Exceptional verbal/written communication skills in a global environment; ability to communicate with technical and business stakeholders
Exceptional people and thought leadership skills; ability to think strategically, influence others and work collaboratively with cross-functional stakeholders.
Knowledge and Skills Desired but not Required
Direct experience implementing industry standards.
In-depth knowledge in industry data standards, regulatory data submission requirements, and demonstrated experience in the development and implementation of standard methodology.
Knowledge of clinical data management systems (e.g., Inform, Rave).
Knowledge of SAS and statistical methodologies.
Ability to leverage technical solutions to manage deliverables and associated quality with assigned projects.
Ability to use programming and other applications to generate insights from data.
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.