Clinical Trials Manager Ambit Biosciences
The Clinical Trials Manager is responsible for managing and monitoring the day-to-day logistics of our oncology trials. This includes managing the overall operation of entire clinical studies including project planning, budgets, resource management, and contract research organization management. The Clinical Trials Manager ensures compliance with good clinical practices, good manufacturing practices, and regulatory guidelines. Recommends and implements innovative process ideas to impact clinical trials management.
Essential Job Functions:
?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.
?Managing with the 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.
EDUCATION:BS or MS in a relevant scientific discipline or health related field. RN or BSN degree or equivalent preferred.
EXPERIENCE:Minimum of six (6) years of relevant experience in clinical research management with a biotech/pharmaceutical company. Oncology experience preferred.
COMPETENCIES AND SKILLS:?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.
?Identify and manage resourcing needs for assigned projects, including internal and external outsourced services (i.e., CROs, laboratories, contractors, in-house staff, etc.); participates in the request for proposal process including defining expectations and deliverables; assesses qualifications and experience, and participate in final selection process
?Liaise with several internal stakeholders including Clinical Operations, Regulatory Strategy, Biostatistic and Data management to ensure effective communication around clinical trial and ensure company milestones are achieved.
?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.
?Represent Clinical Site Services at cross functional study progress meetings.
?Travel up to 20%
TECHNICAL KNOWLEDGE:Equipment: PC, scanners, facsimile machine, voice mail and email systems, and other common machines. Must have the ability to be trained on new equipment.
Software Knowledge:Windows, MS Office (Outlook, Word, Excel, PowerPoint), and Adobe.
Physical Activities: While performing the duties of this job, the employee is frequently required to sit at desk for a long period of time; intermittently answer the telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The employee may need to use their hands to finger, handle, or feel objects, tools, or controls, and reach with their arms. The noise level in the work environment is usually low to moderate. The vision abilities required by this job include close vision and the ability to adjust focus.
The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Laboratory Activities, if applicable: Experience with biological, animal, and chemical laboratory environments required. Environmental health and safety processes also apply.
||4215 Sorrento Valley Boulevard |
San Diego, CA 92121