Senior Clinical Project Manager

Novavax Gaithersburg , MD 20877

Posted 2 weeks ago

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc.(Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax is uniquely qualified to address the enduring need for innovative vaccines. We utilize our proprietary recombinant technology platform, which combines genetic engineering's power and speed to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

The Clinical Project Manager (CPM) is a study team leader responsible for the clinical operation operational delivery of one or more clinical studies through reporting, including inspection readiness and risk management, and in alignment with the program strategies. The CPM is an expert on the operational strategy of clinical trials, lead CRO and vendor oversight activities, and responsible for developing the study timelines and management of the study budget. The CPM leads and manage the internal cross functional study team and provides regular status reports to internal key stakeholders, including program team and senior management.

Responsibilities include but not limited to:

  • Clinical operation project leader for assigned clinical studies including selection and oversight of full service CROs. Oversees on time study deliverables of key milestones. Establishes vendor management plans and manages CROs and study-related vendors accordingly (inclusive of quality plan).

  • Manage study financials including vendor work order development and approval, invoice review, monitoring spend, facilitate regular forecasting communication between Finance departments. Manages vendor work order changes.

  • Active participant in CRO lead meetings, including regular CRO study team meetings and protocol training (e.g., Investigator Meeting, CRA training), responsible to review key CRO study operational plans (e.g. risk management plan, monitoring plan, communication plan, etc.); proactively provides input to operational strategy, including country and site feasibility.

  • Tracks study progress and proactively escalates project related issues, including related to time, budget, and quality, to the key internal stakeholders to ensure timely resolution of issues.

  • Leader of internal cross functional study team; manages, facilitates and documents meetings (e.g. action log) and facilitates effective decision making, cross functional connectivity, and communications are effective and efficient. Partners with Manufacturing Operations to create clinical trial material labeling and packaging plans, and Clinical Immunology to ensure quality and timely delivery of samples for testing.

  • Ensures comprehensive operational input to protocol design.

  • Lead clinical operations sub-team(s) where appropriate, e.g. for large programs with multiple studies, in accordance with the organizational expectations.

  • Contributes to knowledge management within Clinical Development (incl. lessons learned from previous studies are considered in new study design and implementation).

  • Provides Program Team and Senior Management with regular study updates/status reports on study execution. Acts as a liaison between departments within Novavax for project-related matters.

Minimum Requirements:

  • BS/BA degree or equivalent (background in life sciences preferred). Advanced degree is preferred.

  • 6+ years of industry experience (biotech/pharma) with at least 2 years of clinical project management experience (at least 5 years for senior clinical project management experience).

  • Global clinical trial conduct and clinical operations experience, from start-up to database-lock. A thorough understanding of the processes associated with project and study management.

  • Strong understanding of ICH, Good Clinical Practices (GCPs), clinical, and regulatory operations.

  • Experience in management of vendors and CRO's and managing project to budget.

  • Excellent communication skills and management skills with attention to detail.

  • Strong understanding of ICH, GCP and relevant regulatory requirements.

  • Proficiency with MS Project, Microsoft Outlook, Excel, Word, PowerPoint.

  • Ability travel globally up to 10% of time.

  • Prior experience managing outsourced global vaccine studies preferred.

Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer/Veterans/Disabled

Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director Clinical Project Management

Clinical Research Management

Posted 1 week ago

VIEW JOBS 1/15/2021 12:00:00 AM 2021-04-15T00:00 ESSENTIAL FUNCTIONS: * Recognize, exemplify and adhere to ICON GPHS's values which center around our commitment to People, Clients and Performance. * As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. * As a People Leader, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. * Read, ensure understanding and adhere to all assigned ICON GPHS SOPs and working procedures. Project Management Operations (PMO) * Manage a portfolio consisting of high complexity/high-profile, global, full-service, multi-center projects and the overall process of planning, scheduling and controlling the project from initiation to project closeout to ensure timely completion of the project in a manner that is consistent with the Project/Program Management role. This includes key elements of the following: * Project/Program Management * Project Accounting * Stakeholder Management * Business Development/Commercial Awareness * Communication * Teamwork * Leadership * Client Management * Quality * Document Management * Develop fit-for-purpose resourcing and planning solutions that will be utilized across the PMO to effectively manage studies and ultimately improve key performance metrics. * Represents PMO on internal and external meetings. * Takes on additional responsibilities to enhance the overall PM team tools and practices when required. * Works with Director, Project Management Operations to recruit high talented staff. * Verify that all project targets, timelines, budgets and requirements are met per scope of work. Provide guidance to PMs on proper identification of changes in scope of work and proper communication of those changes with internal and external key stakeholders. * Ensures compliance with all applicable government, corporate, and client policies, regulations, and standards. * Maintains proper communications with other departments to ensure a cohesive and collaborative team approach. People/Management * Serves as line Associate Director for program/project Associate Directors and other PMO staff. * Recruit, train and retain a Project Management Team comparable in quality and effectiveness to the best in the pharmaceutical industry. * Provides coaching and timely constructive feedback for all direct reports. Identifies and implements corrective actions where appropriate. * Monitors individual and team key performance metrics against targets as outlined per departmental standards to ensure targets are achieved. * Build and maintain the performance and effectiveness of project management and the project teams, including regular checks on team health and identification and resolution (including escalation to the appropriate level) of team performance issues. * Cross trains staff to ensure staff rotation and coverage of gaps in assignments as required. * Support PM staff by providing consistent guidance, training, tools and project support to improve the PMs' ability to focus on overall project management, planning and customer service. Project/Client * Development and review of project strategy, timelines, and budgets as part of proposal development and pre-award activities. * Oversees and participates in the preparation and maintenance of study-related documentation. Examples of these documentation include, but are not limited to, bid defense materials, protocols, project management plans, procedural manuals, timelines, institutional review board documents, and project metric reports. * Provides clients with regular study updates and communicate study progress to clients and in a responsible and professional manner. * Serves as a primary interface for the path of escalation with clients in managing performance concerns. Prioritizes those concerns and ensures visibility, traction and ultimate closure of those concerns. * Build and maintain strong working relationships with clients, investigators, and research staff. Other: * Facilitate strategic planning and risk assessment, by managing the development and delivery of appropriate contingency activities in the context of the budget, time, resources and value targets and in accordance with SOPs * Establish and maintain a "sense of urgency" within areas of responsibility to assure rapid, in-depth evaluation and, where appropriate, development of internal and external opportunities while not sacrificing scientific excellence, quality/compliance or agreed upon timelines. * Maintain confidentiality of management information as appropriate. * To undertake other reasonably related duties as may be assigned from time to time. Clinical Research Management Gaithersburg MD

Senior Clinical Project Manager