Support development of Clinical Operations infrastructure; independently manage
multiple Phase 2 and 3 international trials; select and manage CRO and vendor
teams; contribute to protocol development, study planning; oversee and track
study budgets. Report to Senior Director, Clinical Development.
- Oversee development and implementation of Clin Ops SOPs and training program;
- Collaborate with GCP compliance to develop clinical CAPA plans and oversee
Clin Ops and CRO corrective actions;
- Ensure implementation of EDMS system for clinical documents;
- Clin Ops liaison for annual report and IB update;
- Prepare and present department and study progress updates;
- Co-develop study documents including protocols, amendments, CRFs, ICFs,
monitoring plans;
- Oversee CROs and other study partners (IVRS, monitoring, labs); Assist with
CRO and vendor identification and selection process as needs arise; support
development of vendor and investigator work orders, budget and payment process;
- Oversee study activities (investigator recruitment, start-up, enrollment,
monitoring, data collection, reporting);
- Lead and actively participate in cross-functional teams;
- Provide internal and external (vendor and site) training on program and
protocol specifics;
- Travel an estimated 15% of the time.
- BS in Life Sciences/RN or a related discipline or equivalent with minimum
of 5 years industry experience in clinical trial management including vendor
management, monitoring, and technical writing;
- Familiarity with Phase I-III and international trials;
- Solid knowledge of GCPs and ICH guidelines;
- Demonstrated skill in budget negotiation and development;
- Computer proficiency;
- Excellent written and verbal communication skills; and
- Energetic, positive, flexible, team-oriented, and interested in professional
growth
Affymax, Inc.
Human Resources
4001 Miranda Avenue
Palo Alto, CA 94304
careers@affymax.com
