Laboratory Project Set Up Manager
hace 2 semanas
Novasyte
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. CV must be sent in English.
Essential Functions:
- Develop the database design requirements which include configuration definition for full protocols, protocol amendments and sponsor study changes.
- Develop and maintain 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 act 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 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 and Kick-off meetings. Participate in external and internal audits as required.
- Provide day-to-day guidance to more junior staff assigned to the project or within a specific program area; may act as a mentor and 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 recommendations report in order to identify successful and unsuccessful project elements, when applicable.
- Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.
Qualifications:
- Bachelor's Degree in Science or related field preferred. Other equivalent combinations of education, training, and experience may be accepted in lieu of degree.
- Minimum 2 years of clinical or research industry experience, including 1 year of project management/project set up experience preferred or an equivalent combination of education, training, and experience required.
- Advanced level of English.
- Strong interpersonal skills.
- Demonstrated ability to meet deadlines.
- Some experience in leading Phase I-IV clinical trials would be advantageous. Technical and therapeutic expertise would also be advantageous, in addition to significant experience with key customers.
- Demonstrated computer proficiency with Microsoft Office. Working knowledge of Clinical Trials Management Systems would be an advantage.
- Possess an understanding of medical and clinical research terminology.
- Demonstrated ability to work in a fast-paced 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.
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.
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