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.
- 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 Marketing Authorization Applications to regulatory health authorities, 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); advanced degree in field preferred (i.e., PhD, PharmD, MD).
- Knowledge of GCP, ICH, GLP and GMP.
- Proficient computer skills.
YEARS OF EXPERIENCE:
- Minimum of 6 – 8 years of clinical research management 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.
How to Apply
Please provide resume, references, and current location via e-mail to email@example.com. Compensation will be commensurate with experience. No phone calls, please. No recruiters.