Manager Clinical Research Informatics Jobs in Lexington, KY

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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.

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.

In performing the above essential functions, the remit includes, but is not limited to:

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.

What you need:

• Master's Degree

• 6-9 years of experience in a Clinical Research environment

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a requesthere.

Are you a current ICON Employee? Please click here to apply