Senior Bioanalytical Study Manager

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee and manage a portfolio of client projects with direct leadership.

• Oversee the overall performance of projects and portfolios, including resource allocation, budget management, and prioritization.

• Act as the primary operational contact and main liaison between PPD and the client.

• Engage in negotiations and make immediate decisions in collaboration with clients.

• Provide direction and coordination for both internal teams and external clients.

• Facilitate the flow of technical and clinical laboratory information among stakeholders.

• Create and maintain project specifications, budgets, contracts, and controlled master files.

• Ensure sponsor approval and adherence to compliance standards prior to service delivery.

• Maintain compliance with FDA regulations, Good Clinical Practice, PPD SOPs, personnel policies, exposure control plans, and biological specimen transport guidelines.

• Coordinate internal teams and support staff to address procedural, budgetary, and documentation challenges.

• Manage daily project activities, resolve issues, and respond to inquiries.

• Collaborate with IT and data management teams regarding software and functionality related to project management.

• Assist in RFP feasibility evaluations and prepare proposal responses in collaboration with BD and finance teams.

• Ensure accurate invoicing and manage billing for the client's portfolio.

⛳️ Requirements

• Bachelor's degree or equivalent relevant academic or vocational qualifications.

• A minimum of 5 years of relevant experience, or a blend of education, training, and experience that is equivalent.

• Strong understanding of scientific principles and/or business operations.

• Excellent verbal, written, and presentation communication skills.

• Exceptional time management, planning, and organizational abilities.

• Proven analytical capabilities.

• Demonstrated adherence to established procedures and policies.

• Ability to manage multiple tasks effectively in a high-pressure environment.

• Extensive experience and knowledge in Project Management.

• Strong skills in managing client relationships.

• Ability to work effectively with teams at various levels.

• Capacity to thrive in a fast-paced and evolving environment.

• Strong negotiation abilities.

• Capability to work in a laboratory or clinical setting.

• Willingness to undertake occasional travel to site locations and some domestic travel.

• Ability to handle potential exposure to biological fluids and infectious agents.

• Proficient in using necessary personal protective equipment such as safety eyewear, garments, and gloves.

🏝️ Benefits

• A healthy and balanced work environment.

• Opportunities for collaboration and professional development.

• Provision of necessary personal protective equipment required for the role.