Senior Clinical Trials Manager
Company: Jazz Pharma
Posted on: March 18, 2019
OverviewEmployerceuticals 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 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.
We are looking for the best and brightest talent to join our team. If youre 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 youll explore our career openings and get to know Employerceuticals.Position ProfileThe Senior Clinical Trials Manager (Sr. CTM) will be a member of the Employerceuticals 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 Employerceuticals 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 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.
Employerceuticals 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.
Keywords: Jazz Pharma, Philadelphia , Senior Clinical Trials Manager, Executive , Philadelphia, Pennsylvania
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