This company is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases - often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. This company is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know this company.
The Senior Clinical Trials Manager (Sr. CTM) will be a member of the this company's Development Operations team. The Clinical Trials Manager responsibilities include (but are not limited to) the following: Essential Functions
Required Knowledge, Skills, and Abilities
- 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 Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines
- Ensures trial master file is current and maintained
- 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.