* 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.
Qualifications
* 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.
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