Job Summary

The Clinical Trial Project Manager (CTPM) is responsible for leading cross-functional study teams and external partners in the planning, execution, and oversight of Phase 1 clinical studies within exploratory and biopharmaceutics clinical development. The role ensures studies are delivered with high quality, on time, and within budget while maintaining compliance with regulatory and company requirements.

The CTPM also contributes to process improvement initiatives, business transformation projects, and continuous improvement efforts by leveraging internal and external knowledge to optimize study execution.

Key Responsibilities

Study Management

• Lead and execute study management activities, including timeline development, risk management, budget oversight, and overall study delivery.

• Serve as the primary study-level communication lead across internal teams and Third-Party Organizations (TPOs).

• Ensure all stakeholders remain informed of project timelines, issues, risks, mitigation strategies, and accountable actions.

• Proactively identify, communicate, and manage project risks that may impact timelines, quality, or study delivery.

• Provide oversight and approval of cross-functional vendor deliverables.

• Collaborate with exploratory and biopharmaceutics clinical development teams to develop study cost estimates and manage study-level budgets.

• Monitor study expenditures and manage scope or budget changes as needed.

• Anticipate, resolve, and appropriately escalate project issues.

• Hold business partners accountable for agreed-upon deliverables and expectations.

• Partner with TPOs to plan and execute studies across clinical sites.

• Support site identification, qualification, and selection activities.

• Collaborate with cross-functional teams to develop and negotiate detailed clinical study budgets.

• Initiate and support contract execution with investigators and external partners.

• Manage and track investigator payments when applicable.

• Ensure site initiation, monitoring, and closeout visits are conducted appropriately.

• Review monitoring reports, oversee resolution of monitoring findings and data queries, and escalate unresolved quality or performance concerns.

Clinical Trial Operations & Process Management

• Provide clinical operations expertise and cross-functional input for study planning and timeline development.

• Lead study startup and execution activities in collaboration with internal and external stakeholders.

• Coordinate contracts with investigators, consultants, vendors, and third parties as required.

• Communicate study requirements to vendors and oversee deliverables including data acquisition, database design, datasets, and protocol compliance activities.

• Evaluate enrollment feasibility, study design considerations, and local regulatory and ethics requirements to support successful study implementation.

• Develop and/or approve study-level operational documents, including Monitoring Plans and Investigator Training materials.

• Plan, manage, and track study enrollment and recruitment progress.

• Partner with Product Delivery teams to manage investigational product labeling, accountability, reconciliation, and clinical trial material requirements.

• Ensure complete documentation of protocol deviations, investigator information, ethics committee documentation, and all records required for study reports and regulatory submissions.

• Ensure study-level safety review activities are planned, conducted, and documented appropriately.

• Maintain inspection-ready Trial Master Files (TMF) and ensure proper archival practices.

• Ensure accuracy, completeness, and maintenance of Vault Clinical data.

• Support inspections, audits, and regulatory assessments, including preparation and response activities.

Scientific & Therapeutic Area Support

• Serve as a resource for protocol-related and technical questions from internal and external stakeholders.

• Ensure end-user needs are considered in device design, study-related instructions, and training materials as applicable.

• Provide scientific and operational input into clinical and regulatory documentation, including:

  - Study Protocols

  - Investigator Brochures (IBs)

  - Risk Assessments and Profiles

  - Annual Reports

  - Regulatory Briefing Documents

  - New Drug Applications (NDAs)

  - Safety Updates

  - Clinical Study Reports

  - Abstracts, Publications, and Manuscripts

• Support the preparation of responses to Regulatory Agency and affiliate inquiries.

Required Qualifications

• Bachelor’s degree in a scientific, health-related, or relevant discipline with a minimum of 3 years of clinical research experience; OR

• Advanced degree in a scientific, health-related, or related field.

• Experience in clinical trial management, clinical operations, or project management within pharmaceutical, biotechnology, CRO, or healthcare environments.

• Strong leadership skills with demonstrated ability to influence and collaborate across cross-functional teams.

• Excellent verbal and written communication skills.

• Proven problem-solving and analytical abilities.

• Strong organizational, planning, and self-management capabilities.

• High attention to detail and critical thinking skills.

• Experience managing multiple stakeholders, vendors, and external partners.

• Previous experience working on cross-functional projects and teams.

• Ability to travel up to 10%, depending on business needs.

Preferred Qualifications

• Experience supporting Phase 1 clinical studies.

• Knowledge of exploratory and biopharmaceutics clinical development.

• Understanding of GCP, ICH guidelines, and applicaable regulatory requirements.

• Experience with TMF management, clinical trial systems, and vendor oversight.

• Familiarity with study budget management and contract processes.

Core Competencies

• Clinical Project Management

• Clinical Operations Oversight

• Vendor & CRO Management

• Budget & Financial Management

• Risk Management

• Stakeholder Management

• Cross-Functional Leadership

• Regulatory Compliance

• Problem Solving & Decision Making

• Communication & Collaboration