Senior Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Plan, direct, coordinate, and execute tasks for assigned clinical study projects to meet quality, scope, budget, and timeline goals.

• Act as the main point of contact and escalation channel for the client.

• Oversee and manage functional services and external vendors in accordance with set timelines and budgets.

• Administer study budgets, manage scope, out-of-scope activities, change orders, and maintain project financial health.

• Collaborate with clinical operations and functional teams to ensure successful study delivery and clinical activities.

• Create detailed project plans, timelines, risk management strategies, and mitigation plans.

• Guarantee quality management, eTMF inspection readiness, quality notifications, and the implementation of corrective/preventive action plans.

• Establish metrics for tracking trial and team progress.

• Prepare project status updates and communicate progress, KPIs, solutions, and opportunities to clients and senior management.

• Facilitate internal and client meetings, setting clear expectations for project teams.

• Address protocol/study issues and deviations, executing necessary actions.

• Conduct formal presentations, including bid defenses.

• Implement and monitor compliance with study-specific training requirements.

• Assist in business development and marketing efforts, including travel for bid defense meetings.

• Carry out additional duties as assigned by management.

• Maintain compliance with organizational training, time-reporting, and administrative obligations.

• Provide continuous feedback and conduct annual performance evaluations for functional team members.

⛳️ Requirements

• Bachelor’s degree or a comparable combination of education and experience in a science or health-related field (North America).

• Degree or equivalent combination of education and experience in a science or health-related field (EU).

• Advanced degree is preferred.

• At least 7 years of clinical research experience or demonstrated competencies for this role.

• Minimum of 4 years of direct project management experience.

• Experience in managing complex and global clinical trials.

• Willingness to travel domestically and internationally, including overnight stays.

• Proficiency in Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project, eTMF, EDC, and CTMS.

• Strong communication and interpersonal skills to effectively engage with others in a team environment.

• Excellent organizational skills, attention to detail, and a customer service-oriented attitude.

• Knowledge of ICH-GCP and relevant Precision SOPs, with the ability to implement these standards.

• Direct experience in a global, cross-functional project management setting.

• Solid understanding of cross-functional management.

• Good familiarity with project planning, risk management, and change management, along with an awareness of proper escalation procedures.

• Established experience in strategic planning, risk management, and change management.

• High integrity and adherence to professional and ethical standards.

• Capability to lead and motivate a study team towards excellence.

• Ability to foster an environment where study team members feel a sense of ownership.

• Results-oriented, accountable, motivated, and adaptable.

• Proven skills in time management, negotiation, critical thinking, decision-making, analytical abilities, and interpersonal relations.

• Strong presentation, verbal, and written communication skills.

• Familiarity with project management software.

• Extensive experience in pharmaceutical and/or device research is required.

• Experience with oncology and cell and/or gene therapy is preferred.

• Candidates must possess legal authorization to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Discretionary annual bonus.

• Health insurance.

• Retirement savings benefits.

• Life insurance.

• Disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.