Contact:Global Channel Management, Inc.
Posted in: Orange County Science & Engineering Jobs
Senior Clinical Trial Manager needs 5 years of pharmaceuticals/biotech experience
Senior Clinical Trial Manager requires:
- Therapeutic area-Ophthalmology
- Global study management experience
- extensive budgeting and vendor oversight responsibility
- B.S. degree; Advanced degree (e.g. Master, PharmD, PhD) preferred
- 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials
- Extensive experience in the operational and scientific/medical aspects of clinical development.
- Ability to work across broad range of interfaces, and take broad perspective to harmonize processes and procedures.
- Demonstrated ability to develop and manage end to end study operational plan
- Demonstrated ability to operationally execute and deliver a quality clinical trial
- Proven leadership abilities and demonstrated experience directly working in multidisciplinary study teams
- Demonstrated ability to execute within a matrix management model, ideally in pharmaceuticals/biotech
- Timeline, budget and resource management experience required
- Demonstrated experience in change management initiatives preferred
- Program and project management experience preferred
- International experience a plus
Senior Clinical Trial Manager duties:
- Supports the Operational Study Lead by providing study status updates, and informs and as needed escalates issues; Provides operational support as needed at various meeting interactions with, as example, advisors or Partners
- Accountable for the execution and adherence to integrated study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders inclusive of all operational accountabilities, including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as FRI’s SOPs and policies.
- Accountable for accurate and timely entry of study information (e.g. design, results) into ClinicalTrials.Gov in collaboration with RAs and Clinical Affairs