Senior Clinical Trial Manager - Hematology/Oncology - Ireland
The Clinical Trials Manager responsibilities include (but are not limited to) the following:
- 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 (GCPs), 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 our company’s 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 Oncology is preferred
- Proven Management of people in a matrixed environment
- Management of global clinical trials
- Demonstrated working knowledge of GCP, 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.