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.
#LI-PB1
ClinChoice is an Equal Opportunity Employer / Committed to Diversity