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Senior Clinical Project Manager
Sigma Systems. Oversee Investigator Initiated Studies, Collaborative Research, and Expanded Access Programs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in overseeing Investigator Initiated Studies and Collaborative Research, with a strong focus on operational oversight, regulatory compliance, and cross-functional collaboration. Possesses a thorough understanding of oncology and clinical trial processes, ensuring effective project management and stakeholder alignment.
Highest-signal resume keywords
Clinical Trial ManagementOncology ExpertiseCross-Functional CollaborationRegulatory ComplianceProject Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Trial Agreements NegotiationStudy Planning and ExecutionBudget MonitoringRisk Assessment and MitigationData AnalysisStudy Documentation PreparationRegulatory Guidelines KnowledgeStudy Milestone MonitoringContractual Deliverables TrackingSOP Development
Soft Skills
LeadershipEmotional IntelligenceInterpersonal SkillsProblem SolvingCommunication Skills
Tools & Technologies
CyberGrants Portal
Industry Keywords
Clinical TrialsOncologyPharmaceuticalsRegulatory InspectionsCollaborative ResearchExpanded Access ProgramsMatrix EnvironmentStakeholder EngagementCRO CollaborationScientific Deliverables
About the role
Key responsibilities & impact- Oversee Investigator Initiated Studies, Collaborative Research, and Expanded Access Programs
- Provide operational oversight across study planning, execution, monitoring, and closeout
- Lead cross-functional collaboration with Medical Affairs, Clinical Operations, R&D, Clinical Supply, Pharmacovigilance/Safety, Regulatory, Legal, Finance, and other functions
- Serve as operational point of contact for investigators and external research partners
- Monitor study milestones, enrollment, timelines, study drug accountability, contracts, and deliverables
- Identify study risks and operational issues; develop mitigation and contingency plans and escalate significant issues
- Drive alignment on study requirements, timelines, responsibilities, risks, decisions, and next steps
- Assess study drug requirements, supply availability, expiration considerations, and supply risks
- Negotiate and finalize Clinical Trial Agreements and study budgets
- Monitor budgets and track contractual milestones, deliverables, payments, and financial obligations
- Prepare and maintain study documents and correspondence
- Participate in study team and investigator meetings
- Prepare and deliver portfolio and study updates to stakeholders and leadership
- Coordinate internal review of manuscripts, abstracts, presentations, and other scientific deliverables
- Support CyberGrants Portal submissions and serve as backup administrator
- Ensure studies comply with regulations, internal requirements, contracts, and procedures
- Support regulatory inspections and audits
- Lead or contribute to SOP, process, tool, template, and workflow development and continuous improvement
- Provide training on applicable procedures
- Maintain oncology and pharmaceutical regulatory knowledge
- Serve as a subject matter expert, provide guidance, knowledge sharing, and mentorship
- Perform other duties requested by senior management
Requirements
What you’ll need- BS./M.S./Ph.D. in a related life science discipline is preferred
- Thorough understanding of the oncology arena
- Minimum of 3-5 years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials
- Proven leadership skills, executive presence, maturity, emotional intelligence, and written/oral communication skills
- Demonstrated skills working within a matrix environment
- Ability to work collaboratively with investigators, CROs, vendors, and parent-company team members in Japan
- Interpersonal skills and influence to accomplish work without formal authority and ensure optimal team performance
- Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring stakeholder alignment
- Strong attention to detail and ability to establish priorities, schedule, and meet deadlines
- Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions
- Familiarity with the design and conduct of clinical trials and project management in relevant therapeutic areas
- Experience evaluating clinical trial outcomes and basic knowledge of clinical trial outcome standards
- Strong analytical skills with a data-driven approach to planning, execution, and problem solving
- Working knowledge of current global regulatory requirements and guidelines for clinical trials
Benefits
Comp & perks- 7 Months Contract 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score