Project Manager II

We are expanding our global footprint, from our home office in Boston, up to Canada, down to RTP, and over to Taipei.

We do things differently than large CROs. Do you value scientific integrity and a collaborative team environment? If so, you will feel right at home here with dedicated opportunities to discuss your achievements and grow your career through quarterly feedback conversations.

The Project Manager II provides management and leadership to plan, prepare, and execute multiple high quality projects and/or programs.

Internally, the Project Manager II interfaces with clinical monitoring and site management, clinical data management, SAS programming, biostatistics, pharmacovigilance, and medical writing. S/he also interfaces internally with business development, corporate compliance and company leadership, and externally with the sponsor and external vendors.

As a Project Manager II You Will...

• Responsible and accountable for one or more projects.
• Manage assigned projects from start-up to closeout within the approved budgets and timelines.
• Proactively recognize any change in scope, and work collaboratively with contracts and Business Development to develop and ensure timely completion of change orders.
• Develop detailed project plans and prioritizes the tasks to achieve project goals.
• Leverage resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables. Responsible for overseeing production and ensuring the quality and timeliness of project deliverables.
• Responsible for effective communication within the project team and with functional management.
• Provide regular updates regarding the status and progress of the projects.
• Act as the key client contact on assigned projects and develop successful working relationships with client to help secure repeat business.
• Participate in qualified vendor selection and manage vendor activities.
• Coordinate and provide oversight of all elements of the project lifecycle from initial set-up to final invoicing.
• Responsible for the timely identification of project risks and the development and implementation of the mitigations for these risks.
• Ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed, as applicable.
• Represent the clinical project team at investigator meetings and support meeting coordination.
• Responsible for ensuring the project is “audit ready” at all times (project team training records, central files, system validation, etc.).
• Demonstrate thorough knowledge of, and coach others in, the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs and policies.
• With oversight from department leadership, the Project Manager II will assist with the training and mentoring of more junior of experienced Project Management staff.
• Participate in Business Development Activities, as appropriate.
• Participate in department continuous improvement initiatives.
• Execute other duties as may be required by the members of the Company Management team as training and experience allow.
• Strive to consistently uphold Company core values.

Experience + Requirements

• Bachelor’s degree in life/health sciences or related discipline, or equivalent required.
• 4 to 6 years of relevant clinical research experience in a Clinical Research Organization/Pharmaceutical Company, with a minimum of 2 years of Project Management and/or functional team lead experience required. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case by case basis.

• Familiarity with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
• Excellent clinical trial project management, written and oral communication, organizational, and interpersonal skills are required.
• Good working knowledge of drug development process and clinical research methods.
• Proficiency in English (written and verbal).
• Action-oriented and resilient in a fast-paced environment and will have the ability to build effective project teams, motivate others, delegate, and make and implement decisions.
• Ability to build and maintain trust and confidence and communicate effectively with client, external vendors, and internal team members.
• Ability to mentor and delegate.