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Form of workThe Temp-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 managing relationships with external experts to facilitate a wide source of country and disease area intelligence that can be used in study design and operational planning.
A typical day may include:
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 enrollment rates and study start up timelines to advise budget and baseline setting.
Supports the development and implementation of the GTO 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 country level feasibility and centrally derived data to support data driven decisions to improve 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 partners to inform study design and operational planning decisions.
Lead study level activities to generate and deliver patient level insights as the need arises to teams to inform study design and operational planning.
Prove input into a range of continuous improvement activities to ensure consistency of GTO process execution.
In partnership with Clinical Outsourcing provide functional input into the identification, qualification, and relationship management of a range of vendors used in GTO processes
Partner with study teams to develop and implement patient recruitment and retention tactics aligned with defined study strategy.
Develop and maintain knowledge of external clinical trial environment and assess developments for impact on study design and execution
May require up to 25% travel
This role may be for you if:
Strong understanding and experience in operationalizing clinical development programs in a global setting from first-in-human to post-approval
Compelling communicator with ability to translate complex messages to a variety of audiences.
Proven track record to build strong working relationships in a diverse range of team environments
Experience in applying data to advise clinical strategy development
Ability to understand complex business questions and develop effective solutions
Experience in process development, implementation and change management activities
Thrives in a highly multifaceted environment where creativity is key in meeting the needs of key collaborators
Self - motivated, good interpersonal and leadership skills, a team player
Line management experience preferred
To be considered for this opportunity you have a BS in a related field; At least 7 years of relevant industry experience within pharma/biotech, a CRO or consulting is required
