Clinical Trials Manager
Category: Research & Development | Country: United States | State: Pennsylvania| City: Philadelphia| Type: Regular, Full Time | Job ID: 4659
Same job available at both sites
Palo Alto, California, United States
Philadelphia, Pennsylvania, United States
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and haematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
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 Jazz Pharmaceuticals.
The Clinical Trials Manager (CTM) will be a member of the Jazz Pharmaceuticals Development Operations team. The
Clinical Trials Manager will manage individual clinical trials and/or programs.
- 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
- BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred
- Seven or more years of relevant clinical trials experience, with at least four years of experience as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device)
- Travel required.
- Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
- Demonstrated ability to work independently and in a team environment
- Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
- Excellent oral and written communication skills and strong organizational abilities
- Experience in CNS and/or oncology is preferred
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.