Manage the process of designing and launching clinical research studies; Manage activities of the Sponsor/Clinical Research Organization (CRO); Lead colleagues in the design and organization of project components during Start-Up; Develop and maintain best practices within the organization; Accountability and ownership for the quality of all start-up work and sponsor deliverables; Support Business Development and commercial activities to help develop business growth.
location: Morrisville, North Carolina
job type: Permanent
salary: $120,000 - 130,000 per year
work hours: 9 to 5
- Develop the database design requirements which include configuration definition for full protocols, protocol amendments and sponsor study changes
- developing and maintaining client design standards as applicable in accordance with the Clinical Protocol
- Manage study database configuration
- Support internal/external stakeholders in the development of sponsor standards and as a Set-up point of contact
- Collaborate with colleagues during planning meetings regarding project timelines, and project-related issues focusing on capabilities within, but not limited to, Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management
- Responsible for updates to the project, including the action/issues logs, status sheets and timelines during the startup phase, where applicable
- Communicate and coordinate set-up activities with clients and internal customers to ensure that all milestones are achieved
- Proactively manage changes in study related project scope, identify potential risks, and devise contingency plans
- As required, prepare and present study-specific materials and services at Investigator, Kick-off meetings. Participate in external and internal audits as required
- Provide day to day guidance to more junior staff assigned to project or within a specific program area may act as a mentor as well as assist in the training and development of more junior staff
- Participate in improvement projects as defined by the relevant process improvement management team
- Conduct project lesson learned sessions and create a recommendations report in order to identify successful and unsuccessful project elements, when applicable
- Ability to manage higher complexity studies involving elaborate database configuration. . Lead in the development of sponsor specific standards and program-specific set-up procedures
- May act as a Program Lead for specific Customer study programs
- Participate and/or provide materials and information for Bid Defense meetings
- Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.
- Possess strong leadership and interpersonal skills.
- Demonstrated ability to meet deadlines.
- Experience in successfully leading Phase I-IV clinical trials.
- Demonstrated technical and therapeutic expertise, in addition to significant experience with key customers.
- Demonstrated computer proficiency with Microsoft Office.
- Experience of working with Clinical Trials Management Systems
- Possess an understanding of medical and clinical research terminology. Demonstrated ability to work in a fast-paced, high stress environment.
- Knowledge of Project Management processes and terminology.
- Excellent organizational and time management skills.
- Excellent accuracy and attention to detail skills.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
skills: Biology, Chemistry, GLP (Good Laboratory Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.