Clinical Team Lead

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

📋 Description

• Lead the success of clinical research projects through cross-functional study leadership.

• Recognize and address clinical risks while contributing to quality risk management strategies.

• Evaluate study protocols and materials, including case report forms (CRFs).

• Oversee clinical operations including timelines, metrics, resources, budgets, and activities.

• Create monitoring tools and strategies.

• Supervise site performance and operational planning.

• Organize and conduct training sessions for investigators, team members, and conferences.

• Facilitate the study start-up process, which encompasses site selection, progress monitoring, data assessment, and supply management.

• Provide project management and sponsor with regular status updates.

• Conduct regular teleconferences with the clinical team.

• Act as an escalation point for Clinical Research Associates (CRAs) and collaborate with site personnel.

• Manage communications and documentation regarding site decisions.

• Engage in Request for Proposal (RFP) and business development discussions.

• Review monitoring visit reports to ensure they are finalized promptly.

• Assist Project Managers with assigned project management responsibilities.

• Aid in the management and development of In-house CRAs and CRAs.

⛳️ Requirements

• Minimum of 8 years of experience in clinical research within the CRO, pharmaceutical, or biotechnology sectors.

• 1 to 2 years of experience leading clinical operations within clinical trials.

• At least 2 years of experience in on-site monitoring.

• Preferred experience in therapeutic areas such as Neurology and Pain.

• Bachelor’s degree (BA/BS) in a life science, nursing, pharmacy, or a related discipline is preferred.

• Proven understanding of medical and therapeutic area knowledge along with medical terminology.

• Strong written, verbal, and presentation communication skills.

• Exceptional attention to detail and comprehension of high-quality scientific standards.

• Display honesty, integrity, accountability, and mutual trust.

• Strong critical thinking and practical problem-solving skills.

• Capacity to adapt in dynamic environments.

• Willingness to travel as required, potentially up to 25%.

🏝️ Benefits

• Medical insurance

• Vision insurance

• Dental insurance

• Health Savings Account (HSA)

• Flexible Spending Account (FSA)

• Employee Assistance Program (EAP)

• Life insurance

• Disability insurance

• 401(k)

• Paid time off

• Holidays

• Parental leave

• Bereavement leave

• Support for work-life balance and flexibility