Senior Clinical Project Manager (Remote)

Everest Clinical Research•,

11h•Hybrid

About The Position

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. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Everest’s headquarters are located in Markham Ontario, Canada with additional locations in: Bridgewater, New Jersey; Shanghai, China; Taipei, Taiwan; and multiple offices in 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. To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as a Senior Project Manager for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA or Canada in accordance with our Work from Home policy. Job Overview: The Senior Project Manager position is responsible for 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, and performs overall company-wide project progress tracking utilizing strategic planning and project tracking methods and tools. This position ensures that ongoing projects under their scope of have existing project plans as required by the established Standard Operating Procedures (SOPs); and ensures that project progress status is properly tracked and reported, and issues are promptly identified and resolved. The incumbent will work with functional area directors and managers to be jointly accountable for smooth project start up, continuation, and successful completion, and will interact with clients for projection of resource requirements and project management purposes. This position is 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. This position is accountable for reporting of project progress status to Everest internal management and its clients, for activities including, but not limited to site selection, study start-up, clinical operations, statistics, data management, subject randomization and drug supply management (Interactive Web Response Systems [IWRS]), data monitoring and/or adjudication committees, regulatory submissions, vendor management, and medical/scientific writing. When required, the incumbent 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 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.

Nice To Haves

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

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.