Associate Director, Project Management

Everest Clinical Research Corporation; Bridgewater Township (NJ); Hybrid; USD 150,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life & AD&D insurance

Short- and long-term disability

Tuition reimbursement

Fitness reimbursement

Employee assistance program (EAP)

401(k) retirement plan

Generous paid time off and sick leave

Performance-based bonus

Job summary

Everest Clinical Research Corporation is seeking an Associate Director, Project Management to lead planning, execution and oversight of clinical development programs. You will manage project managers, coordinate with cross-functional teams, and ensure regulatory compliance across ICH, FDA, EMA, and Health Canada.

This is a remote (or in-office) leadership role with full-time responsibilities, driving high-quality deliverables within timelines.

Qualifications

• B.Sc. or M.Sc. in life sciences or health-related field.
• 12+ years of clinical research and development experience.
• Proven ability to lead and develop others within a function.
• Strong understanding of cross-functional processes in clinical operations, statistics, data management, and regulatory affairs.
• Knowledge of ICH guidelines and FDA/EMA/Health Canada regulations.

Responsibilities

• Lead and mentor project managers and senior project managers.
• Review new PM applicants with senior leadership.
• Develop and maintain governing documents for project management.
• Plan and implement client service delivery across portfolios.
• Ensure quality deliverables and adherence to SOPs.
• Prepare monthly progress reports and stakeholder communications.
• Coordinate with sponsors and vendors.
• Monitor budgets, resources, timelines, and risks.

Skills

Leadership

Budgeting

Cross-functional collaboration

Regulatory compliance

Communication

Problem solving

Education

B.Sc. or M.Sc. in life sciences or health related field

Job description

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s Corporate headquarters are located in Ontario, Canada and US headquarters in New Jersey, USA, with additional physical offices in Asia and Europe.

Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as anAssociate Director, Project Management working remotely (or in office).

Associate Director, Project Management:

This leadership role will oversee the project planning, communication and execution of clinical research and development services offered by Everest. Direct reports include those Project Managers and Senior Project Managers assigned to report to the Associate Director, Project Management. In-direct reports/subordinates are those Project Managers who are assigned to the tasks overseen by the Associate Director, Project Management.

JOB ACCOUNTABILITIES:

• Training, management, and oversight of Project Managers, including performance assessments.
• In consultation with the President of Everest, review new Project Manager Applicants and recommend hires for interview processing.
• Develop, update and review governing documents for use within this functional area.
• Plan and implement new client service delivery requests within client portfolio; supporting evolution of existing client portfolio, providing holistic biometrics deliveries across multiple clinical development programs.
• In consultation with the President of Everest, further develop and establish policies and SOPs in project management and assurance of quality deliverables.
• Facilitate the efforts of functional area directors and managers in project planning, identification of tasks and deliverables, assessment of resource needs and utilization.
• Perform project progress tracking for responsible projects using strategic planning and project tracking methods and tools. Provide monthly project progress status reports for individual ongoing projects.
• Check and ensure that responsible projects carried out at Everest will have a properly tracked and periodically reported project plan, as required by the established SOPs.
• Conduct responsible project progress status meetings with individual project teams periodically, with focuses and close attention to the projects which require close follow up or immediate actions.
• Through the periodic review meetings, issues such as lack of planning, lack of resources, poor team performance, or other external factors negatively impacting the ongoing projects, are promptly identified and brought to the attention of the functional area directors and managers. Work with the functional area directors and managers to jointly ensure smooth project starting up, continuation, and successful completion.
• In consultation with the President of Everest, interact with clients for projection of resource requirements and project management purposes.
• Manage projects with activities focused on data management, statistics, medical writing, subject randomization and drug supply management (IWRS), administration of data monitoring and adjudication committees, as well as preparing drug submissions to regulatory agencies.
• Integrate information to define work scopes and estimate budgets, develop and manage cross-functional project work plans including resource requirements and utilization, budgets, quality deliverables and timelines.
• Manage all project management aspects of assigned Phase I -IV clinical trials and in accordance to ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements.
• Lead cross-functional project teams. Manage the planning, implementation, conduct and reporting of assigned projects within the established timelines and budgets, and with the quality and requirements necessary for regulatory approvals.
• Coordinate activities between Everest and trial sponsors, and with various supporting groups or vendors when necessary.
• Proactively track and manage the financial status against budget and reconcile expenses across sub-streams of activities.
• Proactively track and manage project tasks against timelines and hours spent/budgets, alert management when there are risks of having major deviations.
• Prepare project status reports and maintain accurate and current details. Present project status to internal and external stakeholders.
• Function as meeting facilitator for the meetings involving various internal and external participants.
• Function as facilitator of problem solving and conflict resolution.
• Communicate project action items and key decisions through timely minutes and follow up actions.
• Conduct “lessons learned” meetings with project team members to learn from failures and prevent same from future projects.
• Contribute and/or participate in the performance evaluation of staff who performed under the responsible projects.
• When required, the incumbent may assist the organization in responding to and preparing for Request for Information and Request for Proposals, and subsequently defining work scopes and budgets, and performing contract administration activities.
• When required, perform clinical trial planning, management, and site monitoring from the initiation of a trial to its closure.

QUALIFICATIONS:

• B.Sc. or M.Sc. in life sciences or health related field.
• 12+ years’ experience in clinical research and development within a pharmaceutical, biotechnology or CRO setting.
• Demonstrated ability to lead and develop others within functional area.
• Demonstrated understanding of cross-functional processes including clinical operations, statistics, data management, subject randomization and drug supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing.
• Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.
• Ability to define scopes and estimate budgets, plan and manage projects, including resource requirements and utilization, hours spent vs. budgets, key deliverables and timelines.
• Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets.
• Excellent interpersonal, oral and written communication skills. Demonstrated strong negotiation and presentation skills.
• Strong ability in problem-solving including conflict resolution.
• Experienced as a clinical trial monitor, initiating, monitoring and closing out clinical trials will be desirable.

Benefits & Compensation:

We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a 401(k) retirement, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com .

Estimated Salary Range: $150,000 - 200,000.

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.