SURGE Therapeutics · 19 hours ago
Senior Clinical Project Manager
United States
Full-time
Remote
Senior Level
7+ years expSURGE Therapeutics is dedicated to transforming cancer immunotherapy to improve survival outcomes for patients. The Senior Clinical Project Manager will lead clinical trial implementation teams, manage clinical operations, and ensure compliance with regulatory standards while collaborating with various stakeholders.
BiotechnologyHealth CareLife Science
Responsibilities
The Senior Clinical Project Manager plans and manages overall clinical operations for assigned clinical trials and programs; including timelines, budgets, resources, investigational sites, vendors, and key project deliverables. This role will ensure compliance with SOPs, regulatory requirements, and ICH/GCP guidelines, while maintaining alignment with assigned strategies and goals. This includes strong coordination and communication to oversee clinical program activities with other functions, including next-stage and long-term planning
Lead and manage a multidisciplinary clinical trial team to ensure all trial deliverables are met according to timelines, budget, quality standards, and operational best practices
Maintain a high level of professional expertise through familiarity with clinical protocols and projects
Triage CRO and clinical site questions
Manage selection of study vendors for assigned studies and throughout the life of assigned clinical trials
Select investigational sites with input from internal stakeholders and vendors
Review and refine clinical operation plans, including monitoring project plans
Work with clinical supplies and CMC to determine IP requirements
Work with operations to oversee investigative sites' adherence to pertinent regulations through review of monitoring reports and audit reports as well as communications with investigators, study site personnel, & CRAs
Providing input and contributing to study-related documents
Work with clinical team to establish budget and timelines for the study
Review clinical regulatory documentation for study submission, including but not limited to CTA modules, IB, IMPD, EC, safety reports, and labels
Develop the Clinical Study Report as needed to support the project team
Identify and provide solutions to clinical trial issues and/or risk management
Provide input together with the Clinical Project Team on responses to questions from Health Authorities, Ethics Committees, or IRBs
Providing or facilitating training to clinical study teams on protocol-specific topics
Participate in internal and external audits
Manage communication of study status and guidance to internal stakeholders
Participating in the selection of our CRO; reviewing the CRO contract, including scope of services
Supervise adherence to scope of work within timelines and budget
Oversee and drive the preparation and updates of Investigational Drug Brochures (IBs) and annual reports (AR/DSUR)
Contribute to and initiate process improvement initiatives
Manage the development of in-house operations SOP’s, guidelines, and systems
Collaborate with other department members to promote and assure compliance and alignment of all processes and procedures
Participate in document quality control
Oversee the preparation and management of clinical trial site budgets; establishing project milestones, budgets, and timelines for study conduct together with the study team; establishing a detailed project plan
Build initial, follow-up, and close-out study budgets
Monitor the recruitment rate of the study and taking appropriate and timely corrective actions, as needed
Track all aspects of the clinical trial, providing regular progress reports
Update management team with project milestones, costs, and projections for future activity (providing various strategic scenarios and proposals with proactive or corrective action when needed)
Participate in the overall project planning, optimization, and consolidation with the project team
Working closely with medical experts and other cross-functional leads for the design of clinical trials within the project
Report progress on deliverables to the project team, identifying variances, and presenting solutions
Manage operational aspects of the clinical project in terms of timelines, costs, and resources
Proactively evaluating risks at operational level and building contingency plans for discussion within the project team
Serve as a Subject Matter Expert and mentor to the project team
Special projects as requested
Qualification
Required
University degree, preferably in a biologic/scientific discipline
Minimum of 7-10 years of R&D experience in biotech, pharmaceutical, or relevant clinical CRO experience, including 5+ years in clinical trial management
Experience in executing multiple phase I-III global clinical trials (oncology preferred)
Must have knowledge of FDA regulatory requirements
Must exhibit ability to solve problems and work independently as well as work well in a team
Must have demonstrated multi-tasking ability, managing multiple conflicting priorities effectively
Strong interpersonal skills, reflecting confidence, responsiveness, flexibility, and diplomacy
Exceptional leadership skills, including ability to lead, influence, and manage conflict, change, and teams
Excellent written and verbal communication skills
Strong computer skills (Excel, Word, Power Point, MS Project) and presentation skills
Ability to travel (likely minimally but potentially up to 30%); this position is otherwise fully remote
Preferred
Secondary experience in surgical oncology/device trials is a plus
Benefits
Excellent benefits; medical, dental and vision, including a 401k match and flexible time off
Company
SURGE Therapeutics
SURGE Therapeutics seeks to dramatically improve cancer patient survival by disrupting cancer immunotherapy is deployed.
2-10 employees
Funding
Current Stage
Growth StageTotal Funding
$58MKey Investors
Bioluminescence VenturesCamford Capital
2023-07-19Series B· $32M
2022-10-17Series A· $26M
Leadership Team
Michael Goldberg
Chief Executive Officer
Recent News
Google Patent
2025-05-04
2025-02-10
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