Clinical Study Manager

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

📋 Description

• Lead and manage project activities for globally dedicated clinical trials sponsored by clients.

• Collaborate with the Global Trial Study Leader to ensure effective operational delivery.

• Implement assigned studies in accordance with ICH GCP, local regulations, standard operating procedures (SOPs), timelines, and budgetary constraints.

• Strategically plan and operationally execute specific tasks within the designated clinical trials.

• Work alongside functional leads to guarantee milestone achievements and project goals.

• Choose and supervise CROs/vendors, encompassing budget and contract negotiations as well as performance monitoring.

• Review and authorize monitoring documents and plans, and conduct oversight monitoring visits as necessary.

• Evaluate and endorse pertinent study plans.

• Manage and participate in study team meetings, reviewing agendas and minutes.

• Analyze protocol deviation outcomes and actions to identify trends across various sites and studies.

• Oversee study-level issues, risks, and decisions, while implementing strategies for mitigation.

• Own and evaluate trial operational data, which includes CTMS data.

• Review and supervise internal trial reports.

• Ensure that studies are always inspection-ready and assist with regulatory inspections.

• Prepare for agency inspections, focusing on document readiness, tracking, and storyboard creation.

• Aid in data review for database lock and the writing and reviewing of Clinical Study Reports (CSRs), including appendices.

• Gather, assess, and organize study documents for the trial master file and regulatory submission.

⛳️ Requirements

• A minimum of 5 years of experience in the pharmaceutical industry and/or clinical research organizations.

• At least 3 years of oversight experience in clinical study management, with significant support experience (e.g., clinical trial assistant/associate or lead CRA).

• Familiarity with early-phase clinical studies or Phase 2 and 3 studies.

• Experience in global or international studies or programs.

• Experience in multiple therapeutic areas is preferred.

• Demonstrated success in managing projects within defined scope, time, and budget constraints.

• Experience in vendor selection and oversight.

• Strong leadership and organizational abilities.

• Exceptional communication and interpersonal skills.

• Knowledge of global regulatory and compliance standards for clinical research, including US CFR, EU CTD, and ICH GCP.

• Awareness of local country regulations may be necessary.

• Proficiency in project management tools and methodologies.

• Fluent in business English, both oral and written.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage when applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.

• Minimal travel requirements, with occasional travel opportunities to support key trial meetings.