Remote Senior Clinical Project Manager Clinical Research & Oncology

Job Description

Job Description

Senior Clinical Project Manager – Clinical Research & Oncology

Job ID: 37795497
Job Type: Contract – 7 Months
Work Arrangement: 100% Remote
Company: Sigma Systems

Job Summary

Sigma Systems is seeking an experienced Senior Clinical Project Manager to oversee Investigator-Initiated Studies (IIS), Collaborative Research, and Expanded Access Programs (EAP). This remote, 7-month contract opportunity is ideal for a clinical research professional with experience in clinical drug development, clinical trial operations, cross-functional project management, and pharmaceutical research, preferably within oncology.

The Senior Clinical Project Manager will lead study planning, execution, monitoring, and closeout while partnering with Medical Affairs, Clinical Operations, Research & Development, Regulatory, Pharmacovigilance, Clinical Supply, Finance, Legal, investigators, and external research partners. The successful candidate will drive study timelines, manage operational risks, support budgets and contractual obligations, and ensure compliance with applicable clinical trial regulations and internal procedures.

Key Responsibilities

• Oversee the operational management of Investigator-Initiated Studies (IIS), Collaborative Research, and Expanded Access Programs.

• Coordinate study planning, execution, monitoring, and closeout activities to meet established milestones and deliverables.

• Lead cross-functional collaboration across Medical Affairs, Clinical Operations, R&D, Regulatory, Pharmacovigilance/Safety, Clinical Supply, Finance, Legal, and Clinical Business Operations.

• Serve as a key operational contact for investigators, Contract Research Organizations (CROs), vendors, external research partners, and internal stakeholders.

• Monitor study timelines, patient enrollment, milestones, study drug accountability, contractual obligations, and deliverables.

• Identify study risks and operational challenges, develop mitigation plans, and escalate significant issues when appropriate.

• Coordinate study drug supply planning by evaluating enrollment projections, supply availability, expiration considerations, and potential supply risks.

• Collaborate with Finance, Legal, Clinical Business Operations, and investigators on Clinical Trial Agreements (CTAs), study budgets, payments, and contractual milestones.

• Track study budgets, invoices, payments, financial obligations, and completion of contracted deliverables.

• Prepare, review, and maintain study documentation, correspondence, and required records.

• Facilitate study team meetings, investigator meetings, cross-functional discussions, and decision-making activities.

• Prepare and communicate study and portfolio updates to Medical Affairs, project stakeholders, and leadership.

• Coordinate investigator-submitted manuscripts, abstracts, presentations, and other scientific deliverables, including applicable legal, intellectual property, and safety reviews.

• Support CyberGrants Portal submissions and provide backup administrative support as needed.

• Ensure studies comply with applicable regulations, internal procedures, and contractual requirements.

• Support regulatory inspections and audits by providing study-specific documentation and operational expertise.

• Contribute to the development and continuous improvement of SOPs, workflows, templates, tools, and training materials.

• Share subject matter expertise and provide guidance to team members and cross-functional stakeholders.

• Maintain knowledge of oncology research, current medical practices, and applicable pharmaceutical regulations.

Required Qualifications

• Bachelor's, master's, or doctoral degree in a related life sciences discipline preferred.

• Minimum of 3–5 years of industry experience in clinical drug development, clinical program development, or equivalent academic experience in clinical trials.

• Thorough understanding of the oncology therapeutic area.

• Familiarity with clinical trial design, conduct, project management, and evaluation of clinical trial outcomes.

• Basic knowledge of clinical trial outcome standards.

• Working knowledge of current global clinical trial regulatory requirements and guidelines.

• Demonstrated experience working in a matrixed organization and coordinating cross-functional teams.

• Strong project leadership, communication, interpersonal, and stakeholder management skills.

• Ability to influence and drive progress without formal authority.

• Experience facilitating project meetings, supporting decisions, and aligning internal and external stakeholders.

• Strong analytical, organizational, problem-solving, and prioritization skills.

• Excellent attention to detail and ability to manage multiple study timelines and deliverables.

• Sound judgment, maturity, emotional intelligence, and professional presence.

• Ability to collaborate effectively with investigators, CROs, vendors, internal teams, and international stakeholders, including colleagues in Japan.

Preferred Experience

• Oncology clinical research or pharmaceutical drug development.

• Investigator-Initiated Studies (IIS) and Collaborative Research program oversight.

• Expanded Access Programs (EAP).

• Clinical trial agreements, study budgets, financial tracking, and investigator payments.

• Clinical supply planning and study drug accountability.

• Regulatory compliance, inspection readiness, audit support, and SOP development.

• Scientific publication review, including manuscripts, abstracts, and presentations.

Relevant Skills and Keywords

Senior Clinical Project Management | Clinical Research | Clinical Trial Management | Oncology | Clinical Drug Development | Investigator-Initiated Studies (IIS) | Collaborative Research | Expanded Access Programs (EAP) | Medical Affairs | Clinical Operations | Research and Development (R&D) | Clinical Trial Agreements (CTA) | Study Budget Management | Clinical Supply Management | Patient Enrollment | Study Monitoring | Study Closeout | Risk Management | Cross-Functional Leadership | CRO Management | Regulatory Compliance | Global Clinical Trial Regulations | Pharmacovigilance | SOP Development | Audit Readiness | Clinical Research Documentation | Scientific Publications | Stakeholder Management

Contract Details

• Position: Senior Clinical Project Manager

• Job ID: 37599353

• Contract Duration: 7 months

• Work Arrangement: Remote

• Recruiting Company: Sigma Systems