Biometrics Project Manager

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee the planning and coordination of various biometrics projects spanning Data Management, Biostatistics, and Statistical Programming.

• Manage project timelines, risks, scope, quality standards, and client expectations effectively.

• Serve as the primary point of contact for clients, ensuring strong relationships are maintained.

• Monitor the financial health of projects, including budgets, gross margins, forecasts, revenue recognition, and invoicing support.

• Prepare reconciliations for budgets and manage contract change orders in collaboration with contracts and portfolio teams.

• Strategically plan and allocate resources such as data managers, statisticians, and programmers utilizing resource-management tools like Runn and Pulse.

• Maintain milestone schedules across the portfolio and ensure adequate resourcing prior to critical peaks.

• Document project risks and manage compliance with GCP, regulations, and relevant SOPs.

• Address and resolve project-related issues, negotiating timeline or resource alterations with clients as needed.

• Facilitate root-cause analyses and corrective and preventive actions (CAPAs) with the QA team while sharing lessons learned.

• Identify and implement improvements in project management processes.

• Contribute to PMO and Operations initiatives, including the development of SOPs, training materials, and tools or technologies.

• Assist in business development by providing technical insights for proposals, budgets, and bid-defense meetings.

• Foster client satisfaction, repeat business, account expansion, and cross-selling opportunities.

• Supervise project-management support staff when assigned and mentor lead statisticians or programmers.

• Encourage a positive and collaborative team culture while modeling best practices.

⛳️ Requirements

• A Bachelor’s degree (BSc) or higher in a pertinent scientific, numerical, or project management field.

• A minimum of 5–7 years of experience in the clinical research or pharmaceutical sector.

• Significant experience in managing clinical trials or biometrics deliverables.

• Proven capability in leading or coordinating biometrics functions across Data Management, Biostatistics, and Statistical Programming.

• A successful track record of delivering projects or portfolios on quality, timelines, and budgets.

• Strong numerical skills and comfort with project financials.

• Good grasp of clinical trial data and regulatory requirements.

• Familiarity with CDISC standards, including SDTM and ADaM.

• Understanding of statistical deliverables, such as TLFs and SAPs.

• Knowledge of database lock processes.

• Excellent verbal and written communication skills.

• Strong stakeholder management and negotiation abilities.

• Exceptional organizational and time-management skills.

• A proactive and solution-oriented mindset towards problem-solving.

• Strong interpersonal and collaboration abilities.

• Proficiency in project management and collaboration tools.

• Solid understanding of ICH-GCP principles and the clinical trial regulatory framework.

• Flexibility to adapt to changing circumstances or organizational structures.

🏝️ Benefits

• Equal opportunities employer.

• Inclusive and diverse working culture.

• AI-assisted recruitment with human-made assessments, selection decisions, and hiring outcomes.