Contract Sr Mgr GTO

Hybrid or Remote, NJ - Pharmaceutical & Biotech - Remote - Full time

Date Posted: 5/9/2024

Contract Senior Manager Global Trial Optimization
Hybrid or Remote, NY/NJ
12 months renewable

Contract Senior Manager, Global Trial Optimization (GTO) will lead program or study level activities to inform the clinical development strategy, clinical study concepts, study protocols and operational plans that will enable predictable delivery of clinical programs and studies. They will play a key role in developing and maintaining relationships with external experts to facilitate a wide source of country and disease area intelligence that can be utilized in study design and operational planning.

Lead study level feasibility processes to generate high quality and timely data to inform study design, optimal geographical placement and operational planning. Partner with teams during CRO led feasibility activities to support validation of study and country level enrolment rates and study start up timelines to inform budget and baseline setting. Supports the development and implementation of the Global Trial Optimization function through process initiatives and change management activities. Partner with Data and Analytics function to review and identify appropriate central data sources and work with study teams to define assumptions for data curation and insight development. Articulate the data story to teams based on based on country level feasibility and centrally derived data to support data driven decisions to enhance protocol design. Project management of study level country landscape assessment activities and the collection of targeted feasibility information to support early assessment of operational feasibility for conducting clinical trials. Lead study level engagements to obtain, analyze and deliver high quality targeted information from external stakeholders to inform study design and operational planning decisions. Lead study level activities to generate and deliver patient level insights as required to teams to inform study design and operational planning. Prove input into a range of continuous improvement activities to ensure consistency of Global Trial Optimization process execution. In partnership with Clinical Outsourcing provide functional input into the identification, qualification and relationship management of a range of vendors utilized in Global Trial Optimization processes. Partner with study teams to develop and implement patient recruitment and retention tactics aligned with defined study strategy.

REQUIREMENTS:
Exceptional interpersonal & leadership skills. Applied advanced expertise and implements the operational strategic direction and guidance for respective clinical studies. Can demonstrate expert knowledge and a data driven approach to planning, executing, and problem solving. Advanced communication skills via verbal, written and presentation abilities. Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization. The ability to influence and negotiate across a wide range of collaborators. Knowledge of ICH/GCP and regulatory guidelines/directives. Advanced project management skills, cross-functional team leadership and organizational skills. In order to be considered qualified for this role a minimum of a Bachelors' degree and 5+ years of relevant industry experience .Advanced degrees may be considered in lieu of relevant experience. Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents. You will also need technical proficiency trial management software and MS applications to be considered.

Please contact Darren Gutowski at dgutowski@clarkdavis.com




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