Research & Development Institute (RDI) is a tech-enabled CRO that helps In Vitro Diagnostic manufacturers who struggle to get FDA clearance for their products by sourcing the blood samples they desperately need through physicians and labs.
RDI received a large investment in 2021 that has allowed it to transition from a founder led business into a world-class diagnostic CRO with scientific experts and a CLIA lab that allow it to manage larger and more profitable projects.
Job Overview
Manage a team of clinical staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and meeting project objectives.
Essential Functions
- Manage staff in accordance with policies and applicable regulations. Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development, rewarding and disciplining employees, and addressing employee relations issues and resolving problems.
- Participate in the selection for hiring new employees by conducting candidate review and participating in the interviewing process.
Ensure that new employees are properly onboarded and trained.
- Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and training experiences, as applicable.
- Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training.
- Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
- Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
- Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
- May collaborate with other clinical teams and other functional leadership to manage project related challenges and to achieve exemplary customer service.
- Participates in corporate or organizational departmental quality or process improvement initiatives.
Qualifications
- Prior clinical trial experience including experience in a management / leadership capacity or equivalent combination of education, training and experience.
- In-depth knowledge of applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- Good leadership skills.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
- Written and verbal communication skills including good command of English.
- Excellent organizational and problem solving skills.
- Effective time management skills and ability to manage competing priorities.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
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