Associate Director – Project Management

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Oversee the planning, communication, and execution of clinical research and development initiatives.

• Train, manage, and supervise Project Managers, including conducting performance evaluations.

• Review applicants for Project Manager positions and recommend hires in collaboration with the President.

• Develop, update, and review governing documents, policies, and Standard Operating Procedures (SOPs).

• Plan and execute new client service delivery requests while supporting existing client portfolios.

• Facilitate project planning, task identification, deliverable identification, and resource assessment across various functional areas.

• Monitor project progress using strategic planning and project tracking methods and tools.

• Provide monthly reports on project progress status.

• Conduct status meetings on project progress and escalate issues related to planning, resources, performance, and external risks.

• Ensure seamless project initiation, continuation, and completion in collaboration with functional area directors and managers.

• Engage with clients regarding resource needs and project management.

• Manage projects that involve data management, statistics, medical writing, Interactive Web Response Systems (IWRS), monitoring and adjudication committees, and regulatory submissions.

• Define work scopes and budget estimates; develop and manage cross-functional work plans, resources, budgets, quality deliverables, and timelines.

• Oversee Phase I–IV clinical trials in compliance with ICH, FDA, Health Canada, EMA, and other relevant regulations.

• Lead cross-functional project teams and coordinate activities with sponsors, supporting groups, and vendors.

• Track financial status, expenses, project tasks, timelines, hours, and budgets; notify management of any significant deviation risks.

• Prepare and present project status updates to both internal and external stakeholders.

• Facilitate meetings, problem-solving sessions, conflict resolution, action items, and key decision communications.

• Conduct lessons-learned meetings and contribute to the evaluation of staff performance.

• Assist with Requests for Information (RFIs), Requests for Proposals (RFPs), work scopes, budgets, and contract administration as needed.

• Perform planning, management, and site monitoring for clinical trials from initiation to closure when required.

⛳️ Requirements

• Bachelor's or Master's degree in life sciences or a health-related field.

• Over 12 years of experience in clinical research and development within a pharmaceutical, biotechnology, or Contract Research Organization (CRO) environment.

• Line management experience is essential.

• Proven ability to lead and develop others within the functional area.

• Demonstrated understanding of cross-functional processes, including clinical operations, statistics, data management, subject randomization, drug supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing.

• Familiarity with ICH guidelines, FDA, Health Canada, and EMA regulations.

• Ability to define project scopes, estimate budgets, and manage projects, including resource requirements, utilization, time spent versus budgets, key deliverables, and timelines.

• Demonstrated leadership skills, including goal-setting and driving results within allocated resources, timelines, and budgets.

• Excellent interpersonal, oral, and written communication abilities.

• Strong negotiation and presentation skills.

• Exceptional problem-solving skills, particularly in conflict resolution.

• Experience as a clinical trial monitor, including initiating, monitoring, and closing out clinical trials, is desirable.

🏝️ Benefits

• Medical, dental, and vision insurance coverage.

• Life and Accidental Death & Dismemberment (AD&D) insurance.

• Short- and long-term disability coverage.

• Tuition reimbursement program.

• Fitness reimbursement.

• Employee Assistance Program (EAP).

• 401(k) retirement plan.

• Generous paid time off and sick leave.

• Opportunity to earn a performance-based bonus.

• Accommodations in the recruitment and selection process for candidates with disabilities.