Senior Clinical Systems Manager
Planet Pharma - Plainsboro, NJ
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Job DescriptionTarget Pay Rate: 110-125/hr salary will be commensurate with experience Overview The Senior Manager is a key contributor within Strategic Feasibility organization, responsible for supporting and advancing 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, ensuring feasibility insights are translated into clear, actionable inputs for program and study teams. The role also partners with and supports related Site Management and Feasibility functions, including eTMF Oversight, Site Management, Site Alliances, and Site Contract Management. Key Responsibilities Feasibility Delivery & Strategic Support • Support Associate Director and Director-level Feasibility Leads in the execution of end-to-end feasibility activities across assigned programs and studies. • Contribute to data-driven early indication and program assessments, including competitive landscape evaluation and operational risk identification. • Support the development and refinement of study-level feasibility assessments, 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. • Contribute to the creation and maintenance of study-level enrollment forecasts aligned with approved operational plans. • Support feasibility-related deliverables required for governance, program reviews, and internal decision forums. Broader Operational Contribution In addition to core feasibility responsibilities, this role contributes to 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 approaches and feedback loops that inform study planning and execution. • Support 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 activities, and follow-up on identified issues. • Support site contract and budget-related activities by contributing country- and site-level assumptions, timelines, and operational execution, including participation in cross-functional discussions related to CTA execution and startup risks. Qualifications Education • Bachelor's degree required (scientific, medical, or healthcare discipline preferred). Experience • ?5 years of experience in pharmaceutical, biotechnology, or CRO clinical drug development. • ?2 years of direct experience in feasibility, study planning, site identification, and enrollment forecasting, with exposure to related startup, site management, eTMF, or contract management activities. • Demonstrated experience supporting clinical operations functions 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 stakeholder management and communication skills in a global, matrixed environment. • Ability to work independently while effectively supporting senior feasibility leaders. • Proficiency with MS 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 • Strong attention to methodological rigor and data quality. • Comfortable operating in a fast-paced, evolving environment with shifting priorities. • Collaborative, pragmatic, and solutions oriented. • Detail-oriented with a strong sense of ownership and accountability. • Demonstrates self-awareness and openness to feedback and continuous development. • Able to balance strategic thinking with hands-on execution. Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements. Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Created: 2026-03-10