Career Opportunities at Spectrum Pharmaceuticals

At pharmaceutical R&D firm, ensure company compliance w/Pharmacovigilance regulations & Standard Operating Procedures. Oversee Pharmacovigilance Dept. Ensure full & timely recording & reporting of safety data to authorities. Ensure accurate medical assessment of safety data including adverse events & recalls. Promote safety awareness. Develop strategy & plans. Implement, organize & manage dept activities & patient registries. Train, mentor & develop dept staff. Oversee & facilitate pharmacovigilance training. Act as company liaison for pharmacovigilance meetings. Develop, forecast & manage dept budget. Analyze data to predict safety trends.

Job location: Irvine, CA.

Send resume to: Earl Falls, Spectrum Pharmaceuticals, Inc., 11500 S. Eastern Ave., #240 Henderson, NV 89052.

Lead Clinical Data Management (CDM) team. Lead analysis, development & troubleshooting of electronic data management systems. Write SOPs for tech orientation & usage of CDM systems like electronic data capture (EDC) & other DM functional aspects. Lead design & development of CDM infrastructure & perform maintenance. Design & test user screen for EDC for clinical trial study setups. Ensure efficiency & security of CDM systems by developing & performing edit checks to locate software study setup & software vulnerabilities. Integrate CDM systems w/ad-hoc clinical tools & perform regular remote server management of CDM systems. Ensure CDM systems adhere to CDISC standards, CFR part 21, Good Clinical Practices, & ICH guidelines.

Job location: Irvine, CA.

Send resume: Earl Falls, Spectrum Pharmaceuticals, Inc., 11500 S. Eastern Ave., #240, Henderson, NV, 89052.

Assist with coordination of clinical studies within the Clinical Operations area.  Demonstrate initiative and originality in organizing, systematizing and coordinating activities.

Primary Responsibilites to include:

• Demonstrate superior communication and organizational skills in addition to the technical skills required for overseeing clinical studies.

• Recognize the urgency of meeting established schedules and be able to prioritize tasks and time to meet those schedules.

• Ability to manage and report on the conduct of clinical studies, as directed.
• Help identify and select trial sites.  Conduct qualification, initiation, interim monitoring close-out visits, and perform drug accountability  (approximately 50% travel required).
• Ensure the timely collection of appropriate regulatory documents from study sites.
• Develop materials that support the conduct of clinical studies including:  informed consents, site reference manuals, monitoring flow sheets, CRF completion guidelines, etc.)
• Review clinical documents for accuracy and completion (1572, consents, protocols, meeting minutes, etc).
• Ability to coordinate the activities related to an investigator’s meetings. 
• Participate as a member of project teams and coordinate efforts of other areas of the Company to support clinical project schedules.
• Remain current with applicable regulations concerning development and conduct of human clinical trials (CFRs, ICH).  Communicate to investigators the rudiments of GCP and their related responsibilities.
• Demonstrate working knowledge of relevant clinical trial SOPs.   Draft or revise Clinical SOPs as directed.
• Ensure assigned studies adhere to approved protocols.
• Maintain a level of accuracy that minimizes data query rate and ensures data are accurately transcribed to meet SOP and audit expectations. Identify and provide solutions for data trends.
• Support other team members and facilitate team cohesion; play an active role in personal training and development needs.

Job Qualifications:

• Have an in-depth understanding of clinical research.
• Have a working knowledge of the relevant SOPs.
• Have the necessary interpersonal and communication skills to establish professional working relationships with colleagues and site personnel.
• MS Word, Excel, in-depth knowledge of other presentation programs a plus.
• Minimum BA or BS degree with 5+ years direct clinical operations experience.
• Strong, organizational planning and follow-through skills.
• Excellent language and grammar skills, ability to write clearly and concisely.
• Attention to detail and the ability to prioritize.
• Ability to work well under pressure and with tight schedules.
• Ability to plan and schedule workload and work effectively with others.
• Ability to exercise judgment within generally defined practices and policies for obtaining data.
• Self-direction and motivation are mandatory.
• Ability to resolve problems positively and professionally.
• Demonstrated leadership skills in a multi-disciplinary team environment.
• Ability to interact with all levels of management.

Availability:

• Must have the quality-service attitude and be willing to work additional hours to meet deadlines.
• Travel is required to make site visits. (approximately 50% overnight travel is required.)

Salary and Benefits:

Salary Commensurate with experience. Benefits Program including health, dental, vision, life, AD&D and long-term disability, 401K with Company matching.

Position Type: Full Time, Employee

Contact:

Respond immediately with résumé and cover letter indicating Job Title to:
jobs@spectrumpharm.com