Associate Laboratory Project Set-Up Manager (Remote)

JOB OVERVIEW

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.

RESPONSIBILITIES

• Develop the database design requirements which include configuration definition for full protocols, protocol amendments and sponsor study changes.
• Proactively manage changes in study related project scope, identify potential risks, and devise contingency plans.
• Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.
• Participate in improvement projects as defined by the relevant process improvement management team.
• Responsible for updates to the project, including the action/issues logs, status sheets and timelines during the startup phase, where applicable.
• Conduct project lesson learn sessions and create a recommendations report in order to identify successful and unsuccessful project elements, when applicable.
• May act as a mentor as well as assist in the training and development of more junior staff.
• Participate in external and internal audits as required.
• As required, prepare and present study-specific materials and services at Investigator, Kick-off meetings.
• 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.
• Communicate and coordinate set-up activities with clients and internal customers to ensure that all milestones are achieved.
• 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.
• Provide day to day guidance to more junior staff assigned to project or within a specific program area.

MINIMUM EDUCATION REQUIRED AND EXPERIENCE

• Minimum 2 years of clinical or research industry experience, including 1 year project management / project set up experience. Preferred Or
• Equivalent combination of education, training, and experience. Required
• Bachelor's Degree Science or related field. Preferred
• Other Equivalent combination of education, training and experience may be accepted in lieu of degree. Required

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• Excellent organizational and time management skills.
• Working knowledge of Clinical Trials Management Systems would be an advantage.
• Knowledge of Project Management processes and terminology.
• Some experience in leading Phase I-IV clinical trials would be advantageous. Some technical and therapeutic expertise would be advantageous, in addition to significant experience with key customers.
• Possess strong interpersonal skills.
• Demonstrated ability to work in a fast-paced environment.
• Possess an understanding of medical and clinical research terminology.
• Demonstrated ability to meet deadlines.
• Demonstrated computer proficiency with Microsoft Office.
• Excellent accuracy and attention to detail skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status