Senior Clinical Systems Manager

Overview

The Senior Manager, Strategic Feasibility is a key contributor within the Strategic Feasibility organization, responsible for delivering high-quality, data-driven feasibility assessments across all phases of clinical development. This role partners closely with Associate Director- and Director-level Feasibility Leads to support early indication assessments, study-level feasibility, country and site identification, investigator outreach, and enrollment forecasting.

The role ensures feasibility insights are translated into clear, actionable inputs for program and study teams and collaborates closely with related Site Management and Feasibility functions, including Site Management, Site Alliances, eTMF Oversight, and Site Contract Management.

Key Responsibilities
Feasibility Delivery & Strategic Support

Support Associate Director and Director-level Feasibility Leads in executing end-to-end feasibility activities across assigned programs and studies.

Contribute to data-driven early indication and program feasibility assessments, including competitive landscape evaluation and operational risk identification.

Support development and refinement of study-level feasibility plans, country and site identification strategies, and enrollment forecasts.

Participate in investigator and site outreach activities, as needed, to inform feasibility assumptions and validate recruitment strategies.

Create and maintain study-level enrollment projections aligned with approved operational plans.

Support feasibility deliverables required for governance forums, program reviews, and internal decision-making processes.

Broader Operational Contribution

In addition to core feasibility responsibilities, this role supports adjacent Site Management and Feasibility activities where feasibility, site readiness, documentation, and startup intersect.

Support cross-functional initiatives related to site management strategies, early site engagement, startup planning assumptions, and study-level operational risk identification.

Collaborate with Site Management and Site Alliance Leads on investigator outreach strategies and feedback loops that inform study planning and execution.

Contribute to review and discussion of site-level risks, gaps, and mitigation strategies in partnership with study teams.

Support study-specific eTMF oversight activities in collaboration with eTMF Oversight teams, including documentation planning, completeness and quality review, inspection readiness, and issue follow-up.

Contribute to site contract and budget-related activities by supporting country- and site-level assumptions, timelines, and operational inputs, including participation in cross-functional discussions related to CTA execution and startup risk.

Qualifications
Education

Bachelor's degree required; scientific, medical, or healthcare discipline preferred.

Experience

Minimum of 5 years of experience in pharmaceutical, biotechnology, or CRO clinical drug development.

At least 2 years of direct experience in feasibility, study planning, site identification, and enrollment forecasting.

Exposure to related activities such as study startup, site management, eTMF, or contract management strongly preferred.

Demonstrated experience supporting clinical operations across multiple programs or studies.

Strong understanding of clinical trial design, execution, and phases of clinical development.

Skills & Competencies

Strong analytical skills with the ability to interpret data and translate insights into operational recommendations.

Excellent communication and stakeholder management skills in a global, matrixed environment.

Ability to work independently while effectively supporting senior feasibility leadership.

Proficiency with Microsoft Office, particularly Excel and PowerPoint, and relevant analytics and clinical systems/tools.

Solid understanding of ICH-GCP and the clinical development lifecycle.

Attributes of a Successful Candidate

Demonstrates strong attention to methodological rigor and data quality.

Thrives in a fast-paced, evolving environment with shifting priorities.

Collaborative, pragmatic, and solutions-oriented.

Detail-oriented with a strong sense of ownership and accountability.

Open to feedback and committed to continuous learning and development.

Able to balance strategic thinking with hands-on execution.

Equal Opportunity Employer / Disabled / Protected Veterans

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For temporary assignments lasting 13 weeks or longer, AllSTEM Connections is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

AllSTEM Connections participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.

We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Additional Skills

(none specified)


AllSTEM Representative Contact Info

Account Executive:


Broughton


Branch Phone:


View phone number on click.appcast.io


Location:


Ontario, CA