Senior Project Manager - Remote

Job Description

• 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.

ClinChoice is an Equal Opportunity Employer / Committed to Diversity