[Hiring] Clinical Research Program Manager @Real Soft

Role Description

Provides operational oversight of the Investigator-Initiated Studies (IIS), Collaborative Research, and Expanded Access Program (EAP) portfolio, including:

• Study planning
• Execution
• Monitoring
• Closeout

Leads cross-functional collaboration with:

• Medical Affairs
• Clinical Operations
• Research & Development
• Clinical Supply
• Pharmacovigilance/Safety
• Regulatory
• Legal
• Finance
• Clinical Business Operations
• Other relevant functions

Serves as a key operational point of contact for:

• Investigators
• External research partners

Monitors study progress, including:

• Milestones
• Patient enrollment
• Timelines
• Study drug accountability
• Contractual obligations
• Deliverables

Identifies and anticipates potential study risks and operational issues, develops mitigation and contingency plans with minimal oversight, and escalates significant issues or cross-functional misalignment to management as appropriate.

Drives cross-functional alignment on:

• Study requirements
• Timelines
• Responsibilities
• Risks
• Decisions
• Next steps

Partners with Clinical Supply and cross-functional stakeholders to assess:

• Enrollment projections
• Study drug requirements
• Supply availability
• Expiration considerations
• Potential supply risks

Collaborates with Clinical Business Operations, Finance, Legal, and investigators to:

• Negotiate and finalize Clinical Trial Agreements
• Study budgets

Monitors study budgets and tracks:

• Contractual milestones
• Deliverables
• Payments
• Other financial obligations

Prepares and reviews study-related documents and correspondence, ensuring required documentation is appropriately maintained and retained.

Participates in:

• Study Team Meetings
• Investigator Meetings
• Other study-related meetings

Prepares and delivers portfolio and study updates to:

• Medical Affairs
• Cross-functional stakeholders
• Leadership

Confirms completion of study deliverables in accordance with contractual requirements.

Coordinates receipt and internal review of:

• Manuscripts
• Abstracts
• Presentations
• Other scientific deliverables from investigators

Supports CyberGrants Portal submissions and serves as backup to the Administrator.

Ensures assigned studies adhere to:

• Applicable regulations
• Internal requirements
• Contractual obligations
• Procedures

Leads or contributes to the development, review, implementation, and continuous improvement of:

• SOPs
• Processes
• Tools
• Templates
• Workflows supporting IIS, Collaborative Research, and Expanded Access activities

Maintains knowledge of:

• The oncology therapeutic area
• Current medical practices
• Applicable pharmaceutical regulations

Serves as a subject matter expert for IIS, Collaborative Research, and Expanded Access operational processes and provides guidance, knowledge sharing, and mentorship to team members and cross-functional stakeholders, as appropriate.

Performs other duties and responsibilities as requested by senior management.

Qualifications

• 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 others within and external to the company, including investigators, CROs, vendors, and team members in parent company in Japan.
• Interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance.
• 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.
• Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders.
• Strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
• Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems.
• Familiarity with the design and conduct of clinical trials and project management in relevant therapeutic areas.
• Experience evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards.
• Strong analytical skills with a data-driven approach to planning, executing, and problem solving.
• Working knowledge of current global regulatory requirements and guidelines for clinical trials.

Education

• Bachelor's degree in science/healthcare/business required, advanced degree preferred (PharmD, PhD, MS).
• Minimum 5+ years of industry-based experience in Medical Excellence, operating as a Field MSL, and/or Medical Affairs operations related to biopharmaceutical functions.