Senior Clinical Research Manager
|Job Title:||Senior Clinical Research Manager|
|Location:||New Jersey, USA|
|Contact Name:||Reece Mitellas|
|Job Published:||January 09, 2018 18:38|
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.
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.
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.
SECONDARY DUTIES AND RESPONSIBILITIES include the following:
Reviewing and commenting on documents circulated by other functions within GM&RA (e.g., IB; TLFs; Data Review Conventions; CTRs).
Providing input to the Head of CR for the Clinical Research budget estimations and re-forecasts when required.
Operational activities for approved IIS outside Europe, including periodic contact to sites within the United States and Canada; recording all information in CTMS; requesting contracts from Legal; attendance and participation at GIIRC; assisting Modality Leader with accruals and budgeting upon request.
CORE COMPETENCIES: Managing Clinical Trial Activities, Written and Verbal Communication Skills with particular attention to communicating study information, Managing vendors, Managing blinded readings,
EDUCATION and/or EXPERIENCE REQUIRED: B.S./B.A. degree. 3+ years Clinical Research/Management experience with demonstrated experience in multi-national and/or multi-site clinical studies. Knowledge of GCPs, CFR, ICH and EU guidelines.
Strong organizational, communication and team work skills. Ability to manage several projects simultaneously.
CERTIFICATES, LICENSES, REGISTRATIONS: None required.
Travel is required (20%).
The position is office based.
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