Senior Clinical Project Manager

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🕒 May 16

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• Taking a leadership role in facilitating the efforts of functional area directors and managers in project planning, identification of tasks and deliverables, assessment of resource needs and utilization, and risk identification/mitigation • Ensures that ongoing projects have existing project plans as required by the established Standard Operating Procedures (SOPs) • Ensures that project progress status is tracked and reported, and issues are promptly identified and resolved • Works with functional area directors and managers to be jointly accountable for smooth project start-up, continuation, and successful completion • Interacts with clients for projection of resource requirements and project management purposes • Responsible for defining project scope and estimating budgets, planning, directing, leading project activities, managing resources and budgets, as well as project team performance of cross-functional teams engaged in clinical research and development activities • Accountable for reporting of project progress status to Everest internal management and its clients • May assist the organization in responding to and preparing for Request for Information (RFI) and Request for Proposals (RFP), and subsequently defining scope of work and budgets, and performing contract administration activities

🎯 Requirements

• Bachelor of Science (B.Sc.) or M.Sc., or equivalent, in life sciences or health related field • Over 10 years’ experience in clinical research and development within a pharmaceutical, biotechnology or Clinical Research Organization (CRO) setting • Minimum of 7 years of clinical pharmaceutical industry experience including demonstrated skills and competency in clinical project management tasks • Oncology experience is highly preferred • Knowledge of clinical research process inclusive of Phase I trials through regulatory submission • Previous experience as a clinical trial monitor with experience in initiating, monitoring, and closing out clinical trials is desirable • Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations • Demonstrated understanding of cross-functional processes including site selection, study start-up clinical operations, statistics and statistical programming, data management, subject randomization and drug supply management (IWRS), data monitoring and/or adjudication committees, regulatory submissions, vendor management, and medical/scientific writing • Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets • Solid financial acumen including the ability to define scope and estimate budgets, and plan and manage projects, including resource requirements and utilization, hours spent vs. budgets, key deliverables and timelines • Excellent interpersonal and oral and written communication skills • Demonstrated strong negotiation and presentation skills • Strong ability in problem-solving including conflict resolution

🏖️ Benefits

• 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 • generous paid time off • sick leave • opportunity to earn a performance based bonus