This is a full-time or contract position responsible for overseeing all clinical trial activities from start to finish for US and International studies. This includes trials necessitated by R&D, Regulatory and Marketing.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Manage clinical study monitors and interact with investigational sites.
- Up to 40% travel including international trips.
- Oversee and Manage Contract Research Organizations (CROs).
- Track enrollment and subject progress.
- Review monitoring reports submitted by monitoring personnel.
- Monitor Case Report Forms in-house for quality assurance.
- Facilitate and track the generation, transfer, and resolution of all queries leading up to locking clinical databases.
- Manage the transfer of information and documents between Sponsor and Contract CRAs, and Sponsor and Investigational Sites.
- Manage and maintain Master Study Files.
- Author/review standard operating procedures related to various functional areas.
- Participation in FDA inspections as it related to sponsor pre-approval inspection and investigational site inspections.
- Participate in the completion of clinical studies, and subsequent compilation and submission of a New Drug Application (NDA) for lead drug product orBec® to FDA, to be submitted in the electronic common technical document format (eCTD).
EDUCATIONAL REQUIREMENTS (degree, license, certification):
- Minimum Bachelors Degree in medical field (e.g., nursing, PharmD).
- Knowledge of GCP, ICH, GLP and GMP.
- Proficient computer skills.
YEARS OF EXPERIENCE:
- Minimum of 5 - 8 years of clinical research experience.
PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:
OTHER SKILLS AND ABILITIES:
- Demonstrated experience managing multiple projects simultaneously with aggressive timelines.
- Demonstrated experience with management of Phase 3 multicenter/multinational clinical studies, preferably in the oncology or stem cell transplantation.
- Previous clinical monitoring experience a plus.
- Demonstrated experience managing CROs and/or clinical monitors simultaneously with aggressive timelines.
- Experience and demonstrated ability to manage at a high level of productivity with minimum infrastructure.
- Experience with multinational clinical trials and management of foreign research sites, CRAs, and CROs.
- Experience in developing and making formal presentations.
- Experience in budget planning, management and reconciliation.
- Proficient knowledge of Excel, problem solving and analytical skills required.
- Ability to function well in a cohesive management team environment, with strong goal and results orientation.
- Proven verbal and written communication skills.
Location/Region: Princeton, NJ