Careers
Clinical Trials Manager (CTM-0411)
Ambit Biosciences is a privately-held biopharmaceutical company engaged in the discovery and development of small-molecule kinase inhibitors for the treatment of cancer. With more than 500 distinct kinases identified and over 30 kinase inhibitors in clinical trials or FDA approved, this important class of proteins is a rich area for therapeutic drug development. Ambit Biosciences has the technology, the expertise and the vision to succeed in the kinase space. We are seeking a talented Clinical Trials Manager.
RESPONSIBILITIES:
The Clinical Trials Manager will be an active member and team player of the Clinical Development team. This individual will have multiple responsibilities for managing and monitoring the day-to-day logistics of our oncology trials. These responsibilities will include, but are not limited to:
- Implementing and managing one or more clinical trials through direct interaction and oversight of CROs and/or selected vendors, and project team members.
- Contributing to and/or leading the development of relevant documents for Phase I, II and III studies, including protocols, informed consents, contracts, budgets, CRFs, monitoring plans, and data management plans.
- Ensuring trial activities are compliant with applicable regulations and guidelines, including FDA and ICH GCP guidelines, and SOPs.
- Site and study management, including essential document collection and retention, budget and contract negotiations, study material preparation, enrollment tracking, and report review and monitoring .
- Contributing directly to protocol design by providing input on operational logistics/feasibility, and writing/reviewing various sections.
- Assisting with identification and selection of clinical investigators and study sites.
- Selecting, managing and/or tracking progress of CROs and/or selected vendors in the development and conduct of clinical protocols and generation of applicable reports.
REQUIREMENTS:
- BS or MS in a relevant scientific discipline or health related field. RN or BSN degree or equivalent preferred.
- Minimum of five (5) years of relevant experience in clinical research or life-sciences environment, including three (3) years of industry experience in clinical development or equivalent. Oncology experience highly preferred.
- Multi-center clinical trial experience in Phase I through Phase III US and international clinical trials.
- Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
- Strong knowledge of GCP and ICH guidelines, regulatory requirements and related quality assurance procedures.
- Demonstrated leadership skills, strong written communication and presentation skills including the use of appropriate medical/scientific terminology, critical thinking and problem solving abilities, strong attention to detail and meticulous follow-through; candidate must be a committed team player.
- Excellent computer skills in MS Word, MS PowerPoint, MS Excel, MS Outlook, and MS Project.
- Travel up to 20%