Responsible for the coordination of initiatives and projects related to patient recruitment and retention strategies - collaborating with various key stakeholders internally and externally to increase Otsuka's probability of clinical trial success. Implements innovation strategies at both the project and portfolio level working closely with study teams, functional area leadership and external service providers to drive patient engagement and retention. Develops measurements of success (e.g., KPIs), process for reporting on such measures and implements applicable remediation strategies. Supports internal and service provider facing meetings regarding patient recruitment and retention which may include, but not limited to, strategies, capabilities, study and or portfolio updates. Identifies areas of opportunity to increase diversity and inclusion of study participants in Otsuka Clinical Trials and supports the implementation of initiatives.
Key Job Responsibilities
Significantly contributes to patient recruitment and engagement strategies - development of tools, job aids and communications for patients and trial teams to improve trial outcomes (e.g., screening, enrollment and retention).
Ensure patient recruitment and retention strategies incorporate and remain focused on patients, caregivers and/or family members.
Collaborate with E&C and Legal on a strategy, plan and process for "returning trial results" to patients to accommodate new EU regulatory requirements
Coordinate and include "the voice of the patient" in clinical trial designs and clinical research initiatives.
Liaison with CM to leverage data to drive operational decision making to improve enrollment and screening (ex., performance measures of recruitment vendors/CROs, evaluate/refine costing models, etc.)
Partner with Commercial and MSL teams to ensure patient learning's insights are shared/gained across functions
Identify areas of opportunity and contribute to publication opportunities.
Stays current on leading industry trends that will impact strategies in trial recruitment and effectively applies knowledge, to include training and education to applicable stakeholders.
Coordinate and lead initiatives that drive efficiencies in the speed and quality of clinical trial practices.
Knowledge, Skills, Competencies, Education, and Experience
A minimum of a bachelor's degree in the sciences or related field.
2+ years of experience in clinical research, preferably in support of clinical trial operations.
Working knowledge of GCP/ICH guidelines and in-depth knowledge of clinical research processes, regulation and methodology.
Strong communication skills - written, verbal and presentation.
Possesses a strong skill set to synthesize, analyze and visualize data.
Demonstrates the ability to analyze existing processes and implement effective changes to increase efficiencies and probability of success.
Ability to contribute to and review publications and information sources to keep updated on current regulations, practices, procedures and proposals.
Monitor industry best practices, changes in global regulations and guidelines and recommend changes and upgrades to existing policies, SOPs and systems.
Team player - participate and work effectively on multiple cross-functional teams.
Physical Demands and Work Environment
Travel (approximate percentage): 30%
Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
Statement Regarding Job Recruiting Fraud Scams
Job postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website.