Senior Global Project Manager -Immunology, Metabolic, and Oncology (Sponsor-Dedicated, Remote - US)
About The Position
Within this sponsor, their Clinical Trial Leader (CTL), is a Senior Project Manager level role and serves as a key member of the sponsor's Clinical Delivery Team, providing leadership, direction, and accountability across the full lifecycle of Phase II and III global clinical trials. This role ensures accurate planning, efficient execution, and delivery of trials that bring speed and value to participating subjects and sites. Operating across multi-country, global studies, the CTL provides strategic and operational oversight to ensure trials meet their defined milestones and key performance indicators (KPIs). The successful candidate will demonstrate strong scientific and operational expertise, outstanding communication, and the ability to influence across complex matrix environments. This is a sponsor-dedicated position supporting in-house studies worldwide, with therapeutic areas including Immunology, Metabolic, and Oncology. Candidates must have extensive Project Management experience in Phase II & III trials, experience in at least one of the specified therapeutic areas (additional TA experience is a plus), and a 4-year undergraduate degree.
Requirements
- Bachelor's degree (4-year undergraduate degree) in a relevant field.
- Proven experience leading Phase II & III global clinical trials.
- Therapeutic area experience in Immunology, Metabolic, or Oncology (additional TA experience is a plus).
- Strong scientific and operational expertise across global clinical trial planning and execution.
- Exceptional leadership, communication, and stakeholder management skills in complex matrix structures.
- Ability to strategically plan and drive clinical trial delivery while ensuring patient-focused outcomes.
Responsibilities
- Lead planning and operational feasibility assessments to ensure realistic and achievable trial timelines.
- Oversee trial set-up and ensure team alignment across functions including Statistics, Data Management, Medical Writing, and Site Monitoring.
- Support country allocation and feasibility processes; provide input to optimize site selection and trial readiness.
- Develop and implement trial-level engagement, recruitment, and risk mitigation plans, integrating patient and site feedback to enhance trial design and participant experience.
- Coordinate outsourcing of vendor services, supporting vendor identification, selection, and scope-of-work development.
- Partner with cross-functional teams to ensure readiness across all trial processes - clinical quality, safety monitoring, investigational product management, budgeting, and site support.
- Facilitate and support responses to regulatory authorities, ethics committees, and other external stakeholders.
- Ensure all trial team members receive appropriate study-specific and standardized training.
- Maintain oversight of global clinical trial conduct to ensure compliance with Good Clinical Practice (GCP), internal SOPs, and all applicable regulatory requirements.
- Oversee patient recruitment progress, risk mitigation, and budget tracking to ensure efficient delivery.
- Manage amendments to study documentation and related retraining as needed.
- Ensure effective oversight of vendors and central labs, in collaboration with functional partners.
- Support ongoing communication and coordination across the clinical delivery network and stakeholders.
- For early-phase trials, coordinate activities related to biomarker sampling, genomics, and sub-studies.
- Oversee data cleaning and trial closeout activities, ensuring timely and accurate data delivery.
- Support clinical trial report (CTR) generation and results disclosure to global registries.
- Ensure proper archiving of all essential documents within the Trial Master File (TMF).
- Support scientific publication of trial outcomes where applicable.
- Contribute operational and scientific insight to trial and portfolio-level planning, supporting strategy alignment and risk mitigation.
- Ensure that key issues and insights are raised to the Evidence Team for timely resolution.
- Lead or support trial feasibility assessments that define critical design and execution parameters.
Benefits
- a company car or car allowance
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- flexible paid time off (PTO) and sick time
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Professional, Scientific, and Technical Services
Number of Employees
5,001-10,000 employees
