Senior Clinical Project Manager

This is a fully remote position, open to applicants in Argentina, +2 more states.

📋 Description

• Oversee and direct clinical study operations from initiation to completion in alignment with protocol, sponsor specifications, project scope, budget, standard operating procedures (SOPs), Good Clinical Practice (GCP), and relevant regulations.

• Act as the main operational liaison for assigned sponsors, fostering robust and professional relationships.

• Create, maintain, and manage study schedules, project plans, status updates, action logs, and risk management documents.

• Coordinate cross-disciplinary teams, including clinical operations, data management, biostatistics, statistical programming, medical writing, safety, regulatory, and technology departments.

• Lead internal project discussions, sponsor meetings, and governance dialogues, ensuring prompt follow-up on action items.

• Track study developments, identifying operational risks, quality issues, and timeline challenges, with proactive mitigation and escalation as necessary.

• Supervise study vendors and external partners to guarantee timely and high-quality deliverables in line with project schedules and expectations.

• Assist with budget monitoring, change order assessments, scope management, and resource allocation in collaboration with leadership and stakeholders.

• Ensure readiness for inspections and assist with sponsor audits, internal audits, and regulatory inspections, as needed.

• Foster effective communication and collaboration across global teams and functions.

• **DMC Coordination Responsibilities**

• Lead or assist in coordinating Data Monitoring Committee activities for assigned studies.

• Develop and maintain timelines, meeting schedules, communication strategies, and tracking tools for DMC activities.

• Coordinate the preparation of DMC outputs, including data cuts, tables, listings, figures, reports, presentations, and meeting documents, in collaboration with biometrics and other relevant functions.

• Monitor the readiness of DMC packages, ensuring timely collection, review, quality assurance, and distribution of meeting materials.

• Organize DMC meetings, managing logistics, document flow, agenda oversight, attendance coordination, and follow-up tasks.

• Facilitate communication among sponsors, DMC members, independent statisticians, and internal study teams, while upholding necessary confidentiality and blinding protocols.

• Ensure DMC activities are executed in compliance with the DMC charter, study protocol, sponsor requirements, and applicable procedures.

• Maintain thorough and accurate documentation of DMC decisions, recommendations, meeting minutes, and action items.

⛳️ Requirements

• A Bachelor's degree in life sciences, nursing, pharmacy, public health, or a related field is required; an advanced degree is preferred.

• A minimum of 7 years of clinical project management experience in the pharmaceutical, biotechnology, medical device, or CRO sectors.

• Extensive experience in a CRO setting with responsibilities involving direct interaction with sponsors.

• Proven experience in coordinating or supporting DMC or IDMC activities within clinical trials.

• Strong knowledge of ICH-GCP guidelines, clinical trial processes, and applicable regulatory standards.

• Demonstrated ability to manage multiple projects, priorities, and stakeholders in a dynamic environment.

• Experience in study risk management, vendor supervision, and issue escalation.

• Excellent organizational, analytical, and problem-solving abilities.

• Outstanding verbal and written communication skills.

• Proficiency in Microsoft Office and familiarity with clinical systems such as CTMS, EDC, eTMF, and related project management tools.

• Ability to work effectively with global teams across various time zones.

• Occasional travel may be required based on project or client demands.

• **Preferred Qualifications**

• Experience in oncology, rare diseases, CNS, immunology, or other complex therapeutic areas.

• Experience managing global or multi-regional clinical trials.

• Familiarity with biometrics-related deliverables, including data review, interim analysis support, and reporting packages for DMC meetings.

• Experience with decentralized trial tools, eClinical platforms, or integrated technology-enabled clinical solutions.

• **Core Competencies**

• Clinical project leadership

• Sponsor relationship management

• DMC coordination

• CRO operations

• Vendor oversight

• Risk identification and mitigation

• Cross-functional collaboration

• Timeline and budget management

• Quality and compliance focus

• Decision-making and accountability

🏝️ Benefits

• A selection of comprehensive Medical, Vision, and Dental Insurance plans.

• Paid vacation time and sick leave.

• Annual corporate holidays.

• Enrollment in the 401K Plan.

• Extensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, and more.

• Health Advocate and Employee Assistance Program.