Senior Manager, Clinical Research 9/3/2016

Confidential Company Monroe Township, NJ

Company
Confidential Company
Job Classification
Full Time
Company Ref #
29546654
AJE Ref #
576086483
Location
Monroe Township, NJ
Job Type
Regular

JOB DESCRIPTION

APPLY
JOB TITLE: SENIOR MANAGER, CLINICAL RESEARCH

POSITION TYPE: PERM/FULL TIME

WORK LOCATION: MONROE TOWNSHIP, NJ

TRAVEL IS REQUIRED (20%).

MANAGER COMMENT:

* A HANDS-ON EXPERIENCED MANAGER WHO HAS RUN TRIALS I-IV AND KNOWS THE OPERATIONAL PART WELL.
* EXPERIENCE FROM CORE LABS AND/OR NICHE CROS IS GOOD EXPERIENCE, HOWEVER, ALSO LOOKING FOR HANDS ON CLINICAL RESEARCH MANAGEMENT EXPERIENCE.

ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following:

* Writing and finalizing protocols for the conduct of interventional clinical trials and non-interventional trials as well as studies designed for the retrospective collection of data.
* Selecting and qualifying sites for the performance of clinical trials.
* Reviewing informed consent forms and other Trial Master File (TMF) documents, insuring that all regulatory requirements are met.
* Performing site visits including monitoring activities as needed/assigned, insuring the clinical trial 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 trial 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 lab services).
* Insuring that all project information is up to date in CTMS (e.g. monitoring visits; enrollment).
* Tracking enrollment for each site; proactively addressing issues, insuring protocol compliance.
* Creating and maintaining Trial Master File
* 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 ECs and Investigators as needed.
* Ensuring that projects keep within their approved budget.
* Communicating critical study-related or personnel issues to the Head of CR in a timely manner to facilitate immediate action.