Director, Clinical Research

Bracco Medical Technologies•Princeton, NJ

2d•Onsite

About The Position

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.

Requirements

B.S./B.A. degree preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
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.
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

Nice To Haves

Experience in diagnostic imaging field is desired.

Responsibilities

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
Maintaining the TMF
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