Category: Scientific & Clinical
Title: Operational Excellence and Project Management in Medical Affairs, Oncology
Location: Whippany, NJ
Schedule: 8am to 5pm Mon – Fri.
Duration: 6 months
Start date: ASAP
- Ability to manage assigned projects such as the ISCS and IIR programs, EAPs and non & interventional studies.
- Work within team environment in concept/protocol development and ongoing management of all applicable assigned projects/ programs and internal review committees
- Develop and maintain effective working relationship with key investigators & thought leaders in assigned programs to optimize scientific quality/innovation of clinical study design, execution, reporting and publication
- Operationally lead and manage to ensure all deliverables are met according to timelines, budget, quality standards and operational procedures
- Report progress and issues with their resolution
- Assist in develop outsourcing specifications with respective line functions to facilitate selection of CROs/vendors; manage interface with CROs/vendors in cooperation with the appropriate team members
- Ability to work across functions and be able to leverage relationships to create and execute strategically aligned activities
- Knowledge & tracking of data ongoing, medical/scientific reviews, clinical reports, publications and internal/external presentations.
- Bachelor’s degree (life science preferred)
- Masters in Science or Business Administration - preferred
- Extensive ( 5+ years) study management experience involving Phase 3 studies from planning through regulatory submissions
- Ability to review, understand, and give feedback on Oncology study protocols, CRFs, Monitoring Plans, etc.
- At least 3 years Oncology experience (can be outside of industry).
- Excellent interpersonal and communication skills as chosen candidate will interact internally with cross-functional team members who are needed in reviews of study concepts and protocols and to oversee other aspects of the studies (e.g., Data Management, Statistics, Medical, etc.) and will provide oversight of external academic networks and cooperative groups.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.