Operational Risk Manager Jobs in Cream Ridge, NJ

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 Senior Manager ensures feasibility insights are translated into clear, actionable inputs that inform program and study team decision-making. This role also collaborates 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 the development and refinement of study-level feasibility plans, country and site identification strategies, and enrollment projections.
Participate in investigator and site outreach activities, as needed, to inform feasibility assumptions and validate recruitment strategies.
Develop and maintain study-level enrollment forecasts aligned with approved operational plans.
Support feasibility-related deliverables for governance reviews, program updates, and internal decision forums.
Broader Operational Contribution
In addition to core feasibility responsibilities, this role supports adjacent Site Management and Feasibility activities where feasibility, site readiness, startup planning, and documentation 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 to support investigator outreach strategies and feedback loops that inform study planning and execution.
Contribute to discussions 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 in Microsoft Office, particularly Excel and PowerPoint, and relevant analytics and clinical systems.
Solid understanding of ICH-GCP and the clinical development lifecycle. 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.
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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:
(909) 244-1777
Location:
Ontario, CA