My name is Bhawna and I'm a Technical Recruiter with ACS Group, a leading information technology services and workforce solutions company.
We currently have an opportunity for a 'Project Manager' with one of our clients in the 'Lawrenceville, NJ' area.
Job Title: Project Manager
Job Location: Lawrenceville, NJ
Duration: 6+ Months W2 Contracts
The Clinical Trial Business Partnerships (CTBP) department is focused on executing the business sourcing strategy across all phases of R&D development operations. This group applies a common framework to drive efficient, consistent and compliant processes for vendor relationship and management of major clinical service providers. Serving as a bridge between clinical teams and external services providers, the CTBP is responsible for building the appropriate in-house management/oversight structure and mechanisms, while driving the external collaboration with clinical service providers in effort to yield a multitude of innovative ideas to deliver on goals.
This position reports to the Associate Director, Global Vendor Oversight & Operations. As an integral member of CTBP, the role assists various team members by coordinating tasks related to CTBP business processes.
- Ability to develop a range of written materials such as detailed instructions for high level principles-based documents
- Support and manage the completion of deliverable related to audit and inspection corrective and preventative actions
- Document stewardship in validated document repository
- Strong GCP and ICH knowledge, including local/regional guidelines which are applicable to clinical research and the regulatory landscape
- Ability to effectively manage projects, escalate issues as necessary and meet key milestones
- Ability to lead and facilitate team meetings, that contribute to attaining team goals and resolving complex issues
- Work with autonomy and is able to able to negotiate and influence others without direct authority
- Impacts the success of projects to meet short-term objectives & adhere to project schedule
- Primarily internal communication (limited external)
- Bachelor's degree with a minimum of 5-10 years' experience in global drug development
- Project Management. Experience operationalizing clinical trials, preferred
- Demonstrated knowledge of Good Clinical Practice (GCP) ICH Guidelines and applicable FDA regulations
- Experience in cross-functional, multi-cultural teams and ability to work within a matrix structure
- Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations
- Demonstrated success through facilitation and presentation skills to a globally diverse audience
- Proven time management skills and ability to be flexible to meet job demands and take on new initiatives and improvement efforts
- High level of writing competency, specifically in the appropriate use of grammar, syntax and organization of ideas on paper
- Proactively use judgment and creativity to manage risk and uncertainty, and to anticipate the need for and implement contingency plans. Ability to sustain high levels of performance in a constantly changing environment while supporting multiple projects concurrently
- Proficient in use of MS Office suite including OneNote, Veeva Vault Clinical platform products, SharePoint