Clinical Research Project Manager

Anova Enterprises, Inc.; Schaumburg (IL); On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a Clinical Research Project Manager to lead the delivery and governance of client projects. This role involves providing regulatory guidance, managing project timelines and budgets, and ensuring compliance with clinical standards. You'll have the opportunity to coach project managers and contribute to the successful execution of clinical trials in various therapeutic areas. Join a dynamic team that values proactive communication and relationship management, and make a significant impact in the field of clinical research. If you have a passion for project management and clinical operations, this is the perfect opportunity for you to advance your career.

Qualifications

• 5+ years of experience in clinical operations or project management.
• Therapeutic experience in complex diseases like oncology or cardiology.

Responsibilities

• Lead project delivery and governance for clinical research projects.
• Manage project timelines, budgets, and resources effectively.

Skills

Clinical Operations Management

Project Management

Risk Management

Communication Skills

Regulatory Compliance

Education

Bachelor's Degree in Life Sciences or related field

Certification in Project Management (PMP or equivalent)

Tools

Project Management Software

Clinical Trial Management Systems (CTMS)

Job description

Anova has adopted a project management approach to its planning, prioritisation and delivery of projects/programs.

The Clinical Research Project Manager will lead project delivery and governance for client projects allocated to them. The role will provide regulatory advice and guidance, monitoring and assurance, advocacy and education with respect to programs, projects, and their delivery, to clients and staff at all levels.

Additionally, this will include a reporting framework focussed on value-added advice and early identification of risk and issues for all programs and projects allocated to them.

Responsibilities

Anova-wide Project Management

1. Support the implementation and management of portfolio, programme and project governance frameworks and development of appropriate reporting tools which deliver value;
2. Participation in Anova wide approach to Project Management including resource planning and management, preparing resource plans and the monitoring and reporting of project outcomes;
3. Support organisation wide project reporting with a focus on value added advice and early identification and resolution of risk and issues;
4. Coach and mentor project sponsors and managers;
5. Review programs and projects for deliverability including adequate resourcing, management and governance procedures, and accuracy of financial estimates;
6. Support the procurement of programme and project management services.

Clinical Research Project Management

1. Proactively manage project level operational aspects of clinical trial and compassionate use programs for Anova clients including management of timelines, budgets, resources and vendors;
2. Provide updates on project progress to internal and external program leads;
3. Lead sponsor study start-up process, ensuring project plans are in place and operational for each project;
4. Work proactively with internal and external teams to set priorities in accordance with applicable project plans, company SOPs, ICH/GCP guidelines and regulatory requirements;
5. Ensure all project level program and study documentation is developed and maintained in accordance with company SOPs;
6. Contributes to relevant study documentation including clinical protocols, clinical study reports, regulatory submissions as well as operational plans;
7. Participates in study data review and other review activities as assigned;
8. Liaises with sites, physicians, patients and representatives in the conduct of research and/or compassionate use programs;
9. Provide support to site teams and physicians in the conduct of research programs;
10. Other duties as assigned.

People & Relationship Management

1. Effectively communicating current activities and policies;
2. Managing external contractors, consultants, projects, project teams, and managing the quality and timeliness of outputs;
3. Establish and maintain close working relationships with internal and external contacts including project managers, staff, suppliers, consultants, and contractors;
4. Influence internal stakeholders to achieve the desired outcomes, including process improvement, of the PMO and Anova.

Qualifications

1. 5 years’ experience as a clinical operations or project manager at a sponsor or CRO company is required;
2. Therapeutic experience in complex disease (oncology, rare disease, infectious disease, cardiology, neurology);
3. Understanding of clinical and/or clinical research technology programmes (preferred);
4. Experience in early phase trials (Phase I-II) and FIH trials (preferred).

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Project Management and Information Technology

Industries

Research Services