Job Title: Senior Clinical Trials Manager
Job Location: Palo Alto, CA, United States
Job Duration: Full Time Opportunity
Type of Hire: Direct Placement
Mode of Interview: Telephone Interview Followed by Video Interview.
- Manage external vendors and contract research organizations
- Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual
- Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents
- Assist with protocol development and study report completion
- Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (Google Cloud Platforms), SOPs and study protocols
- Provide guidance, direction, and management to CRAs
- Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities
- Coordinate study supplies
- Negotiate contracts with vendors of clinical trial services
- Review Informed Consent Forms, CRFs, and study related materials Plan and participate in investigator meetings
- Assist and support data query process
- Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines
- Ensures trial master file is current and maintained
Required Knowledge, Skills, and Abilities:
- At least 5 years of experience in clinical trial management Experience in CNS is preferred
- Proven Management of people in a matrixed environment Management of global clinical trials
- Demonstrated working knowledge of Google Cloud Platform, ICH guidelines and FDA regulations Demonstrated ability to work independently and in a team environment
- Travel required. Must be willing to travel 15-25%, including international travel Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
- Excellent oral and written communication skills and strong organizational abilities
Required/Preferred Education and Licenses: BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred
Description of Physical Demands:
- Occasional mobility within office environment. Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment:
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.
What are the 3-4 non-negotiable requirements of this position?
- BA/BS, nursing degree, or advanced degree.
- Degree in the life sciences preferred.
- At least 5 years of experience in clinical trial management.
- Manage external vendors and contract research organizations.
- Must have experience sponsor, study management experience; CRO experience is not a fit.
- Must have experience managing large global clinical trials *Proven Management of people in a matrix environment Management of global clinical trials
What are the nice-to-have skills?
- Neuroscience experience is a plus
– provided by Dice
To Apply: https://www.jobg8.com/Traffic.aspx?U2r8GOUiDKVcIGULUqGSxQm