Feasibility Informatics Manager

IRE • Hickory, NC

8d

About The Position

Feasibility Informatics Manager ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Title: Feasibility Informatics Manager Role Summary: To serve as a technical feasibility strategy expert, leading and managing the process of clinical project feasibility in support of proposal teams by assisting Business Development with the generation of cost proposals, providing input and advice relating to operational strategy, and supporting client interactions and long-term strategic partnerships. To perform as a technical expert in the feasibility strategy development process for internal (e.g., to Business Development Operations) and external clients (e.g., Sponsors), providing strategic input. This includes, but is not limited to: Serving as an expert resource to project teams for feasibility strategy and informatics services (e.g., feasibility during rescue situations). Providing support during bid defense (or potential preferred partner) meeting preparation and attending/presenting at bid defense (or potential preferred partner) meetings. Providing handover to awarded site identification (site ID) team of all relevant feasibility strategy proposed during RFP process, followed by End of Site ID analysis to be performed. To lead the process of clinical project feasibility during standalone feasibility (awarded) projects by managing and being accountable for the delivery of all awarded projects assigned to the individual. This includes, but is not limited to, accountability for all recommendations for next steps with assessment of risks and strategies to manage risks to the project delivery.

Requirements

• Master's Degree
• 6-9 years of experience in a Clinical Research environment

Responsibilities

• Recognize, exemplify, and adhere to ICON's values (Collaboration, Integrity, Inclusion, and Agility) which center around our commitment to people, clients, and performance.
• Recognize the importance of and create a culture of process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs. This includes participation in active sharing of FIM learning across therapeutic teams with a purpose to improve strategic feasibility support and outputs (e.g., leveraging resources and tools, slide development, user-acceptance testing for tools).
• Travel (approximately 20%) domestic and/or international as needed.
• The FM will maintain communication and relationships between all relevant parties to ensure that available intelligence is utilized to deliver optimal, data-driven feasibility strategy solutions. Relevant parties include, but are not limited to: Proposal team members, Project Managers/Strategy Leads, Patient Recruitment & Retention Specialists, Site Identification Managers/Leads, Therapeutic Experts, Therapeutically Aligned clinical teams (as assigned), Business Development Associates, Sponsors, Quality Assurance Associates, and other internal/external experts.
• Preparation of feasibility data by: Collecting data from data assets as well as country associates, site level Investigators, and KOL interviews when required. Determining site profile. Developing appropriate feasibility strategies, including approach and management for standalone feasibilities. Providing full documentation in the proposal that may include incidence/prevalence, treatment practices, reimbursement practices, competitive landscape, enrollment trend analysis, etc. Collaborating with Patient Recruitment, Start-up, and other teams as needed. Ensuring feasibility data is fully evaluated to determine risks to project delivery and that any risks identified are appropriately escalated and solutions planned/discussed within the feasibility strategy (e.g., alternative scenario). Transitioning all pre-award generated data (including strategy) to the Site ID Manager/Lead (with involvement of awarded project team) upon award. Preparing internal project information to support ad hoc requests for information (e.g., early engagement, pre-award, post-award).
• Conduct of evidence-based feasibility by: Establishing viability of proposed project through interrogation of internal and external performance metrics (e.g., previous feasibility data, Industry intelligence, EMR/EHR and RWE data) and resources to establish demographics and data on patient populations. Ensuring all collected data is high-quality, accurate, and fully documented in the ICON feasibility business systems. Performing accurate and correct data analysis and interpretation to support feasibility strategy solutions.
• Preparation for and attendance at bid defense meetings (by phone or in person) by: Supporting and/or presenting strategic project planning.
• Performing as a functional lead with accountability for delivery of high-quality feasibility standalone services (awarded/contracted) by: Initiating, conducting, coordinating, analyzing, and reporting feasibility studies as contracted on time and on budget (managing staff resources). Meeting Sponsor objectives and expectations. Coordinating with the Site ID Lead per RACI. Developing appropriate country and site selection strategies and analyzing/interpreting results to provide protocol feedback and to make appropriate country and site recommendations based on objective analysis (e.g., ranking). Documenting and tracking feasibility study results.

Benefits

• In addition to your competitive salary, ICON offers a range of additional benefits.
• Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
• Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees