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 the Client's major clinical service providers. Serving as a bridge between the Client's 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 the Client's 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 (required) 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.
This 6+ month position starts ASAP.
ALPHA'S REQUIREMENT #20-02218
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
Alpha Consulting Corp
620 Cranbury Road, Suite 201
East Brunswick, NJ 08816