Note: The job is a remote job and is open to candidates in USA. Everest Clinical Research is a full-service contract research organization providing expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries. The Senior Clinical Project Manager is responsible for leading project planning, resource management, and ensuring successful project completion while maintaining communication with clients and stakeholders.
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
Skills
- 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
- Oncology 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
- Previous experience as a clinical trial monitor with experience in initiating, monitoring, and closing out clinical trials is desirable
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
- Generous paid time off and sick leave
- The opportunity to earn a performance based bonus
Company Overview