Clinical Project Manager

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

📋 Description

• Oversee the management of assigned clinical trials throughout the entire study lifecycle, including protocol development, site selection, study completion, database lock, and review of the final clinical study report.

• Handle all facets of clinical trials, such as creating protocols, selecting sites, choosing vendors, locking databases, and reviewing the final clinical study report.

• Prepare or assist in the preparation of protocols, case report forms, informed consent documents, enrollment feasibility assessments, and study conduct plans.

• Coordinate with Legal, Research and Development, Data Management, Medical Writing, Medical Affairs, Clinical Compliance and Training, Regulatory, and Marketing teams.

• Provide updates to senior management and escalate any issues as necessary.

• Manage activities of external teams and vendors, including IRBs, while coordinating the study site team members, physicians, and research staff.

• Identify and evaluate study sites, conduct investigator meetings and site training sessions, prepare and execute research agreements, and negotiate study budgets.

• Create and maintain tracking systems for study management, including screening, enrollment, study completion, adverse events, budgets, forecasts, and milestones.

• Collaborate with internal stakeholders, clinical sites, and external vendors to ensure quality, compliance, efficiency, and accountability.

⛳️ Requirements

• A Bachelor’s degree in clinical research, biostatistics, pharmacy, nursing, or a related healthcare field, or equivalent experience is required.

• 3–5 years of experience in clinical research, demonstrating increasing responsibilities in trial coordination, clinical development, protocol management, or clinical project management.

• Experience in supporting multi-site clinical trials is essential.

• Proven experience in managing external vendors.

• Knowledge of ensuring compliance with relevant regulatory requirements is necessary.

• Familiarity with Good Clinical Practice (GCP), ICH guidelines, FDA and EMA regulations, and applicable clinical trial requirements.

• Understanding of statistical principles, including concepts outlined in ICH E9, and their application in clinical study design and data interpretation.

• Knowledge of clinical study design, endpoints, protocols, and the documentation requirements for regulatory submissions.

• Strong project management capabilities, encompassing scope definition, scheduling, budgeting, risk management, and tracking key performance indicators.

• Experience coordinating with sponsors, contract research organizations, investigators, study sites, regulatory stakeholders, and internal cross-functional teams.

🏝️ Benefits

• Medical and dental coverage starting from the first day of employment.

• Basic life, accident, short-term disability, long-term disability, and business travel accident insurance.

• Employee Stock Purchase Plan (ESPP), allowing the purchase of company stock at a discount.

• 401(k) Retirement Savings Plan (RSP) with employee contributions and company matching contributions.

• Flexible Spending Accounts.

• Educational assistance programs.

• Paid holidays.

• Paid time off ranging from 20 to 35 days based on duration of service.

• Family and medical leaves of absence.

• Paid parental leave.

• Commuting benefits.

• Employee Discount Program.

• Employee Assistance Program (EAP).

• Childcare benefits.

• Reasonable accommodations for individuals with disabilities.