Ref #: 25140

Employment type: Permanent - Full-Time

Location: US - West Coast (home-based)

Posted: 15-Sep-2020

Description

Responsibilities

Planning and management of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Clinical Study Team (CST)
* Input operational expertise into the study design process
* Contribute to the execution of the feasibility process
* Oversee, Site Evaluation and Selection plans by RCTMs
* Ensure delivery of the Global Study Operational Plan (GSOP)
* Contribute to study level goal setting
* Provide input into and / or lead the development of study-specific plans/manuals e.g. CRFs, DMPs, Monitoring Plans and other documents.
* Oversee and contribute to develop study specific materials and tools (e.g. study specific training documents)
* Oversee identification, selection, set-up, and management of vendors, including invoice approval
* Communicate study status (including timelines and deliverables) to key stakeholders (e.g. CST, Program Managers, TA heads, GDL etc.) and oversee updates to relevant systems
* Perform risk assessment and develop risk mitigation strategies, and provide operational input into Study Level Quality & Risk Management Plans
* Coordinate cross-functional review of major issues escalated from RCTMs
* Organize and where appropriate, lead Investigator, Study Coordinator and RCTM meetings and training
* Lead development and implementation of the Global Drug Supply Plan, oversee study-level forecasting, accountability and reconciliation
* Management of study budgets
* Monitor the execution of the clinical study against timelines, deliverables, and budget


Qualifications:

* BA/BS/BSc
* 7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
* Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)


DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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