Clinical Team Lead – Invitro Diagnostics

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

📋 Description

• Take charge of the clinical execution of clinical research trials.

• Serve as the Clinical Project Manager within the main project team.

• Collaborate with the Project Manager and functional leads to ensure clinical trial activities are conducted within contractual and budgetary constraints.

• Supervise the clinical and site management components of trials.

• Act as the representative for clinical delivery to the client.

• Propel clinical project performance towards meeting contracted deliverables and customer requirements.

• Lead communication and coordination with clients and multicultural project teams.

• Formulate clinical project strategies and prioritize tasks with clinical teams and stakeholders.

• Oversee project scope, timelines, quality, budget, risks, resources, and KPIs.

• Create and present materials for new business initiatives and engage in Bid Defense activities.

• Manage subject recruitment and retention, clinical vendor performance, and monitoring visit strategies.

• Utilize data sources, dashboards, risk management, and quality-by-design principles to facilitate proactive problem-solving.

• Uphold project governance, escalation pathways, clinical project planning, SOP adherence, and regulatory standards.

• Anticipate clinical project revenue and oversee project expenses and financial milestones.

• Lead scope modifications and change-order processes.

• Cultivate high-performing clinical project teams and enhance communication and collaboration.

• Ensure precise clinical resource projections and highlight resource limitations.

• Mentor team members and provide constructive feedback to line managers.

• Participate in and oversee submissions to regulatory and ethics committees, including tracking and documentation.

• Fulfill additional assigned responsibilities.

⛳️ Requirements

• University or college degree (preferably in life sciences) or certification in a related allied health profession from an accredited institution.

• Relevant work experience may be considered as a substitute for educational qualifications.

• Bachelor’s degree.

• Over 5 years of clinical research or monitoring experience, or an equivalent combination of education and experience.

• More than 3 years of experience leading project teams through the phases of clinical study start-up, execution, data management, analysis, closeout, and report writing.

• Experience in overseeing external vendors, including CROs, central laboratories, call centers, and DCT providers.

• Knowledge of ICH Guidelines and GCP, including international regulatory standards.

• Proficient in advanced computer skills, such as Microsoft Word, Excel, Project, Access, and PowerPoint.

• Experience managing projects in both matrix and virtual environments.

• Exceptional communication, planning, and organizational abilities.

• Capability to lead by example, foster independent problem-solving, manage competing priorities, and utilize resources efficiently.

• Ability to inspire teamwork and motivate personnel within a matrix system.

• Financial awareness and proficiency with financial tracking systems.

• Capacity to work autonomously and mentor junior project team members.

• Proficient in negotiating and liaising with clients in a professional manner.

• Competence in presenting to staff at all organizational levels.

• Fluent in English, both written and verbal.

• Experience with medical devices is preferred.

• Willingness and ability to work weekends and off-hours as necessary.

• Ability to travel up to 30% globally, including both domestic and international travel.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements and a supportive work environment.