Operations Business Lead – Clinical Research

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

📋 Description

• Assist the Director of Growth & Partnerships in implementing initiatives for clinical research growth and operations.

• Organize activities related to new research sites, partnerships with providers, and opportunities for studies.

• Create and uphold project plans, schedules, action items, and deliverables.

• Monitor stakeholder expectations, deadlines, dependencies, statuses, and outstanding tasks.

• Recognize delays, operational shortcomings, and unresolved matters, escalating them as necessary.

• Promote communication and meetings across various functions.

• Maintain transparency regarding key initiatives and provide consistent updates to the Director of Growth & Partnerships.

• Support the establishment of standardized processes, tools, templates, and workflows.

• Oversee study feasibility assessments and explore new study opportunities.

• Collect information and evaluate staffing needs, patient populations, equipment, space, technology, and investigator availability.

• Manage study startup activities and track barriers to activation.

• Assist with the review of clinical trial budgets and Clinical Trial Agreements (CTAs).

• Back study financial models and profit & loss statements while monitoring financial performance and variances.

• Coordinate strategies for patient recruitment and track performance in recruitment and enrollment.

• Facilitate onboarding for investigators and providers, including meetings, training, and follow-up.

• Manage communications with sponsors and CROs, including requests, site capability materials, presentations, and partnership discussions.

• Maintain trackers for action items, documenting owners, deadlines, decisions, next steps, and responsibilities.

• Identify issues impacting timelines, financial performance, study activation, enrollment, or partner relationships and escalate as needed.

⛳️ Requirements

• Bachelor’s degree in healthcare administration, business, life sciences, clinical research, nursing, or a related field; equivalent relevant experience may be considered.

• 5–7+ years of experience in clinical research, healthcare operations, project coordination, research site operations, or a similar field.

• Proficient knowledge of clinical trial operations and study startup processes.

• Familiarity with study feasibility, clinical trial budgets, and Clinical Trial Agreements (CTAs).

• Capability to understand basic study financials, including revenue, direct costs, overhead, and study-level P&Ls.

• Strong project management and organizational capabilities.

• Proven ability to coordinate activities across multiple departments and stakeholders.

• Excellent attention to detail and aptitude for managing multiple priorities and deadlines.

• Outstanding written and verbal communication skills.

• Ability to recognize barriers and escalate issues appropriately without assuming responsibility for another functional area’s duties.

• Experience in supporting new clinical research sites or expanding research programs.

• Background in working with investigators, physician practices, sponsors, and CROs.

• Experience with CTMS, eRegulatory, EDC, or related clinical research systems.

• Familiarity with patient recruitment and enrollment strategies.

• Knowledge of ICH-GCP, FDA regulations, and clinical research requirements.

• Minimum 5 MBPS download speed and 3 MBPS upload speed for remote work.

🏝️ Benefits

• Annual bonus targeted at 15%.

• Restricted stock units.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Life insurance.

• Pet insurance.

• 401(k) plan.

• Paid time off.

• Wellness programs.

• Expense reimbursement for employees who regularly work from home offices.