Work with clinical team and CRO staff; contribute to protocol development and
writing, planning, study oversight, study budgets, CRO/vendor management and
reporting.
- Assist with CRO and vendor identification and selection process;
- Manage CROs and other study partners (monitoring, data management, labs);
- Manage vendor budget and payment process;
- Manage study activities (investigator recruitment, start-up, drug preparation,
enrollment, data collection, monitoring, reporting);
- Prepare study progress updates;
- Develop protocols, amendments, CRFs, and other study documents;
- Assist in organizing investigator, expert, and other meetings;
- Contribute to clinical SOP development; and
- Travel an estimated 15% of the time.
- BS in Life Sciences/RN or a related discipline or equivalent with minimum
of 2 years industry experience in clinical trial management including monitoring,
data management, contracts, technical writing;
- Familiarity with international trials and Phase I-III;
- Knowledge of GCPs and ICH guidelines;
- Experience working with CROs is a plus;
- 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
