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Everest Clinical Research · 1 hour ago

Senior Clinical Project Manager (Remote)

United States

Full-time

Remote

Senior Level

7+ years exp

Everest Clinical Research is a full-service contract research organization providing expertise-based clinical research services to pharmaceutical, biotechnology, and medical device industries. They are seeking a Senior Clinical Project Manager to lead project planning, resource management, and ensure successful project delivery while maintaining high-quality standards.

Pharmaceutical

Growth Opportunities

Responsibilities

Assure the fulsome and accurate transfer of contracts from initial project proposal to project mobilization, through to project completion and end-to-end financial reconciliation

Manage projects from initiation through closure for full scope regional and global projects, with activities focused on site selection, study start-up (including all systems and plan development), clinical operations, statistics and statistical programming, data management, subject randomization and drug supply management (IWRS), administration of data monitoring and/or adjudication committees, regulatory submissions, vendor management, and medical/scientific writing

Facilitate the efforts of functional area directors and managers in project planning, identification of tasks and deliverables, and assessment of resource needs and utilization

Perform project progress tracking for responsible projects using project planning and tracking methods, tools, and software. 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 and Working Instructions

Prepare project status reports and maintain accurate and current details. Present project status to internal and external stakeholders inclusive of comprehensive risk identification and sound mitigations

Conduct responsible project progress status meetings with individual project teams periodically, with focuses and close attention to the projects that require close follow-up or immediate actions

Through periodic review meetings, identify issues such as lack of planning, lack of resources, poor team performance, or other external factors negatively impacting the ongoing projects and bring them to the attention of the functional area directors and managers. Work with the functional area directors and managers to jointly ensure smooth project start-up, continuation, and successful completion

Function as a meeting facilitator for the meetings involving various internal and external participants

Act as the project management lead interfacing with clients to drive project delivery, communication, problem solving, and issue management; convey scope and resource requirements, financial and contracting statuses, and other project management purposes. Seek Sponsor approval for scope changes, assigned resources, and project decisions when appropriate

Gain a clear understanding of the contracted scope of work, and track and initiate development and completion of out-of-scope work or change orders with the clients, in consultation with internal functional delivery teams, with the goal of ensuring Everest is being compensated for additional scope/value delivered

Coordinate activities between Everest and trial Sponsors, and with various supporting groups or vendors when necessary

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

Proactively track and manage project tasks against timelines and hours spent/budgets; alert management when there are risks of having major deviations

Function as facilitator of problem solving, lessons learned, and conflict resolution efforts. Share information with leadership where appropriate to improve the deployment of future projects

Proactively track and manage the financial status against budget and reconcile expenses across sub-streams of activities. Meet financial performance targets for assigned clinical projects

Integrate information to define scope of work 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 to IV clinical trials and in accordance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements

Communicate project action items and key decisions through timely minutes and follow-up documentation

In consultation with the Senior Project Management Leadership Team, review and contribute to further develop and establish policies and SOPs in project management and assurance of quality deliverables

Contribute and/or participate in the performance evaluation of staff who performed under the responsible projects

When required, may assist the organization in responding to and preparing for RFI and RFP, and subsequently defining scope of work and budgets, as well as perform contract administration activities

When required, perform clinical trial planning, management, and site oversight from the initiation of a trial to its closure

Generate new sales leads by developing trust-based relationships with client counterparts, with the goal of winning repeat and new business based on client relationships established. Identify opportunities to offer additional Everest services to grow an existing client account

Be available to travel, up to 20%, including international travel

Qualification

Clinical project managementClinical research processRegulatory knowledgePain management experienceFinancial acumenLeadership abilitiesInterpersonal skillsProblem-solvingNegotiation skillsPresentation skills

Required

Bachelor of Science or Master of Science in life sciences or health related field

Over 10 year' 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

Pain Management experience is required

Knowledge of clinical research process inclusive of Phase I trials through regulatory submission

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. Ability to identify out-of-scope work and initiate change order discussions with vendors and Sponsors alike

Excellent interpersonal and oral and written communication skills. Demonstrated strong negotiation and presentation skills

Strong ability in problem-solving including conflict resolution