Senior Clinical Project Manager

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

📋 Description

• The Senior Project Manager role entails leading the efforts of functional area directors and managers in project planning, task identification, deliverable definition, resource assessment and utilization, as well as risk identification and mitigation.

• Conducts comprehensive project progress tracking across the company using strategic planning and project tracking methodologies and tools.

• Ensures that all ongoing projects within their scope adhere to existing project plans as required by established Standard Operating Procedures (SOPs); also guarantees that project progress is accurately monitored and reported, with timely identification and resolution of issues.

• Collaborates with functional area directors and managers to maintain joint accountability for seamless project initiation, progress, and successful conclusion, while engaging with clients to project resource needs and facilitate project management.

• Tasked with defining project scope, estimating budgets, planning, directing, and leading project activities, managing resources and budgets, as well as overseeing the performance of cross-functional teams involved in clinical research and development initiatives.

• Responsible for reporting the status of project progress to Everest internal management and clients for various activities, including but not limited to site selection, study initiation, clinical operations, statistics, data management, subject randomization and drug supply management (IWRS), data monitoring, adjudication committees, regulatory submissions, vendor management, and medical/scientific writing.

• May support the organization in responding to and preparing for Requests for Information (RFI) and Requests for Proposals (RFP), defining project scope and budgets, as well as performing contract administration tasks.

⛳️ Requirements

• Bachelor of Science or Master of Science in life sciences or a health-related field.

• More than 10 years of experience in clinical research and development within a pharmaceutical, biotechnology, or Clinical Research Organization (CRO) environment.

• At least 7 years of experience in the clinical pharmaceutical industry, with demonstrated skills and proficiency in clinical project management tasks.

• Experience in oncology is mandatory.

• Comprehensive knowledge of the clinical research process, including Phase I trials through to regulatory submission.

• Previous experience as a clinical trial monitor with skills in initiating, monitoring, and closing out clinical trials is preferred.

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

• Proven understanding of cross-functional processes encompassing site selection, study initiation, clinical operations, statistics and statistical programming, data management, subject randomization and drug supply management (IWRS), data monitoring, adjudication committees, regulatory submissions, vendor management, and medical/scientific writing.

• Demonstrated leadership capabilities, including the ability to set goals for team members and drive towards their achievement in alignment with allocated resources, timelines, and budgets.

• Strong financial acumen, including the capacity to define scope and estimate budgets, and effectively plan and manage projects, encompassing resource requirements and utilization, hours versus budgets, key deliverables, and timelines.

• Exceptional interpersonal and oral and written communication skills.

• Proven negotiation and presentation skills.

• Strong problem-solving capabilities, including conflict resolution skills.

🏝️ Benefits

• 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 plan.

• Generous paid time off and sick leave.

• Opportunity to earn a performance-based bonus.