We're 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 hematology/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
The Senior Clinical Trials Manager (Sr. CTM) will be a member of the Development Operations team. 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 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 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
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!
This position does NOT provide sponsorship so please do NOT apply if you require sponsorship. Thank You
KP Recruiting Group
"Bringing Talent to the Marketplace"
KP Recruiting Group is a well established and very respected recruiting firm. We have built a strong reputation as a premier resource for providing highly qualified candidates for our clients. We are very experienced in many industries and have a wide range of clients. We will serve as your advocate during your career search! Let us do the work for you! There is never a fee for our services!