$90K — $130K *
• Independently manages Biometrics project teams from study start-up through study closeout; departments include but not limited to, Data Management, Biostatistics, Statistical Programming, and Medical Writing.
• Promotes team building and communication to ensure the team functions as one entity.
• Manages multiple and complex projects, ranging in phase and number of Biometrics services involved.
• Serves as the primary liaison between clients, vendors, and project teams.
• Establishes and maintains relationships between clients, vendors and project team, to encourage repeat and/or new business.
• Encourages cross-functional collaboration to ensure deliverables are provided on time, with quality and within budget.
• Generates and maintains project timelines, milestones, and action items.
• Coordinates and leads project team meetings and creates and distributes agendas and minutes.
• Collaborates with finance, manages project financials; manages project budgets, generates monthly accruals, forecasts future accruals and initiates timely invoice generations.
• Proactively identifies out of scope activities and executes necessary change orders.
• Recognizes project issues and facilitates issue resolution; escalates issues, when needed.
• Implements identification of risks, mitigation, management and resolution.
• Participates in the preparation of governance meetings and attends, when needed.
• Provides performance feedback of team members to respective line managers, project teams.
• Provides mentoring and coaching, and oversees junior staff on PM processes, daily PM related tasks, and working on projects.
• Supports the generation and review of contracts (SOW, WO, COs, etc.).
• Confirms required project trainings are completed by team; company wide, client specifics and project specifics.
• Supports the preparation of audits, internal and external, and CAPA completion as required
• Contributes in business development activities; support in preparation of proposals and bid defenses. Works with the contracts team to generate the scope of work and budgets.
• Participates in departmental initiatives and SOP development/review and update.
• Develops and refines processes which lead to greater efficiencies or competitive advantages.
• May develop and refine project management processes within the Company.
• Performs other tasks as assigned by Sr. Management team.
• Requires a bachelor’s degree or higher in life sciences. 5+ years of experience in Pharma / CRO industry with 8+ Years’ experience in Project management.
• Excellent understanding of Biometrics services and processes and inter-dependencies.
• Preferable experience in a prior position in Biometrics and/or managing projects across Biometrics functional areas.
• Ability to solve problems, multitask and work independently with general directions.
• Knowledge of FDA regulations, drug development and PM processes.
• Good understanding of ICH/GCP guidelines.
• Strong presentations skills.
• Strong communication skills, both oral and written.
• Strong team player, interpersonal skills, and customer focused.
• Flexibility to handle multiple tasks and deadlines.
• Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Outlook.
• MBA or PMP certification is preferred.
Valid through: 7/9/2021