Senior Manager Global Trial Optimization

Description

The 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 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.

Additional Skills & Qualifications:

5-7+ Years of Global Trial Optimization (Feasibility) Experience (Pharma/CRO/Biotech) as a LEAD/Manager

Feasibility, Site identification, Patient Recruitment and Retention experience

Feasibility Experience: (country level placement, Country level enrollment, country level feasibility, site identification)

Education: Minimum Bachelors (Masters Preferred)

Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents.

Bachelors Degree minimum

Experience Level

Expert Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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