Bracco Diagnostics Inc. is a subsidiary of Bracco Imaging which is part of the overall Bracco Group. The Company specializes in the clinical development, marketing and sales of diagnostic contrast imaging agents. Bracco Diagnostics Inc. primarily markets its products to hospitals throughout the United States. Bracco Diagnostics Inc. is committed to the discovery, development, manufacturing and marketing of imaging agents and solutions aimed at providing a better use and management in terms of diagnostic efficacy, patient safety and cost effectiveness.
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Job Purpose
The Director, Clinical Research is responsible for leading clinical research activities for a specific program or programs as well as managing all activities associated with performing one or more clinical studies. This person has the responsibility to guide and supervise clinical research activities performed by external vendors (CROs), consultant monitors (when applicable) and clinical study assistants working on assigned projects.
Main Responsibilities, Activities, Duties, and Tasks
- Writing and finalizing protocols for the conduct of interventional clinical studies and noninterventional studies as well as studies designed for the retrospective collection of data
- Identifying, selecting, and qualifying sites to conduct clinical studies
- Reviewing informed consent forms and other Study Master File (TMF) documents, ensuring that all regulatory requirements are met
- Performing site visits including monitoring activities as needed/assigned, ensuring the clinical study is being performed according to ICH/GCP guidelines and meeting the protocol requirements
- Planning, coordinating, and facilitating investigator meetings
- Communicating with study centers, addressing issues, and disseminating study study information
- Training investigators, monitors and site personnel to ensure appropriate collection and reporting of non-serious and serious adverse events, as well as special situations, and any urgent safety measures taken by the site during the study
- Assisting with data flow and query resolution
- Requesting and managing clinical supplies, including coordinating the shipment of the clinical supplies to study sites, over-seeing drug accountability and the return of clinical supplies to Bracco
- Managing vendors and consultants (e.g., central ECG and central lab services)
- Ensuring that all project information is up to date in the Clinical Study Management System (CTMS) (e.g., monitoring visits; enrollment)
- Ensuring the current version of project documentation is filed in Expresso
- Tracking enrollment for each site; proactively addressing issues, insuring protocol compliance
- Initiating payments to investigators
- Overseeing payments to vendors: reviewing invoices including documentation supporting pass through costs
- Overseeing the tracking of receipt of original CRFs in house at Bracco
- Submitting SUSARs to IRBs/ECs and Investigators as needed
- Ensuring that projects keep within their approved budget
- Communicating critical study-related or personnel issues to the Head of Worldwide Clinical Research in a timely manner to facilitate immediate action
- Reviewing, revising, and facilitating the training / approval process for clinical related SOPs
Supervisory Responsibilities
Education
- B.S./B.A. degree preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
Professional Experience, Knowledge & Technical Skills
- 10+ years Clinical Research/Management experience with demonstrated experience in multinational and/or multi-site clinical studies. Knowledge of GCPs, CFR, ICH and EU guidelines
- Strong organizational, communication and teamwork skills. Ability to manage several projects simultaneously. Experience in diagnostic imaging field is desired.
- Ability to manage multiple projects/programs simultaneously
- Ability to manage investigators, consultants, vendors
- Excellent written and verbal communication skills with particular attention to communicating study information
- Taking personal responsibility to achieve results/objectives and makes every effort to achieve the expected outcome of any task
- Ability to work independently, with minimum supervision
- Ability to work in a team
- Ability to deal with competing priorities, meet aggressive timelines within the assigned scope of the project
Core Relationships
- Medical Planning and Management
- Medical Affairs and Scientific Information
- Regulatory Affairs &Medical Writing
- Corporate Quality Management
- Clinical Research Quality Systems
Work Environment
The work environment characteristics described here are representative of those an employee
encounters while performing the essential functions of this job. Reasonable accommodations may
be made to enable individuals with disabilities to perform the essential functions. The employee must be able to communicate via telephone, written correspondence, or spoken word to perform the essential duties of the position.
Bracco Diagnostics Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, or any other protected status.
