Clinical Team Lead

Location: Remote (U.S.)

Employment Type: Full‑time

Compensation: Base $155,000-$175,000 target range (flexible).

Travel: ~15-25% for site visits, investigator meetings, and audits/inspections

Reports To: Senior Director / Head of Clinical Operations (title varies)

The Opportunity

We're seeking a hands‑on Clinical Operations leader to drive execution across pain‑focused clinical trials. You'll be the operational point for sites and CRO partners, overseeing CRAs and site performance, ensuring timelines, quality, patient safety, and inspection readiness across one or more studies. Ideal for someone who enjoys problem‑solving with sites, coaching CRAs, and keeping fast‑moving studies on track.

Core Responsibilities

• Study leadership: Own end‑to‑end operational delivery (SSU → activation → conduct → DBL/CSR → close‑out) for assigned trial(s).
• Site & CRA oversight: Serve as the primary site contact escalation point; direct and support CRAs on monitoring strategy, protocol adherence, risk mitigation, and issue resolution.
• Quality & compliance: Maintain inspection readiness (ICH‑GCP, SOPs); drive CAPA where needed; ensure TMF health and monitoring/alignment to plan.
• Risk‑based operations: Implement / refine risk‑based monitoring (RBM/Risk Assessment), enrollment rescue plans, and data‑driven site performance reviews.
• Start‑up acceleration: Partner closely with SSU on feasibility, site selection, regulatory greenlights, and activation timelines; remove roadblocks early.
• Cross‑functional collaboration: Work with Clin Dev/Medical, Biostats/DM, PV, Clinical Supplies, and vendors to ensure deliverables are met; contribute to protocol, ICF, monitoring plan, and study manuals.
• Vendor/CRO governance: Oversee CRO/Specialty vendors (e.g., central labs, imaging, eCOA, IWRS); review KPIs/SLAs; manage escalations and change orders.
• Budget & timelines: Track against budget, manage scope, and maintain scenario plans for key risks and enrollment variability.
• Documentation: Ensure timely updates in CTMS, eTMF, issue logs, risk registers, and stakeholder dashboards; contribute to CSR inputs.

Required Experience & Skills

• 5+ years in Clinical Operations within a CRO or sponsor (CRO experience strongly valued).
• Recent, relevant pain trial experience is essential, with strong preference for acute pain models (e.g., bunionectomy, abdominoplasty, dental pain, knee/shoulder replacement post‑op). Interest/experience in chronic pain (e.g., osteoarthritis, rheumatoid arthritis) is a plus.
• Demonstrated site‑facing leadership and CRA functional oversight across multi‑site studies.
• Proven command of ICH‑GCP, RBM principles, and inspection readiness.
• Proficiency with EDC, CTMS, eTMF, and standard study tools; strong data‑driven decision‑making.
• Excellent communication (written/verbal), stakeholder management, and conflict resolution skills.
• Bachelor's degree in Life Sciences or related field (advanced degree a plus).

Nice‑to‑Have Qualifications

• Experience with analgesia endpoints, pain scales (e.g., NRS/VAS), rescue medication management, and peri‑operative pathways.
• Global study exposure and/or regional leadership across North America/EU.
• Start‑up and submissions (IRB/IEC/HA), IVRS/IWRS setup, eCOA deployment.
• Budget ownership, change‑order negotiation, and KPI dashboarding.
• Prior involvement in audits/inspections with successful outcomes.

Why Join?

• High‑impact remit in pain therapeutics, with autonomy to fix problems and move fast.
• Collaborative team, remote‑first, and supportive leadership.
• Competitive base compensation with potential upside based on experience.