Senior Clinical Project Manager

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EDETEK Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2009

💊 Pharmaceuticals

🧬 Biotechnology

☁️ SaaS

Pharmaceuticals • Biotechnology • SaaS

EDETEK Inc. is a clinical development informatics company that provides a cloud-native R&D Cloud ecosystem and an integrated eClinical platform to support clinical trials and regulatory submissions. Its product portfolio includes CONFORM™ orchestration and collaboration tools, an eClinical Suite (CTMS, EDC, ePRO/eCOA, RTSM), data integration and metadata hubs, a clinical data lake, and statistical computing and submission-ready environments. EDETEK also offers services — biostatistics and programming, clinical data management, clinical study development, medical writing, and eClinical operations — targeting pharmaceutical, biotechnology, and medical device sponsors. The company emphasizes interoperability, data quality, and AI-enabled capabilities to accelerate study execution and regulatory submissions globally.

📋 Description

• Lead and manage clinical study activities from startup through closeout in accordance with protocol, sponsor requirements, project scope, budget, SOPs, GCP, and applicable regulations. • Serve as the primary operational point of contact for assigned sponsors and maintain strong, professional sponsor relationships. • Develop, maintain, and manage study timelines, project plans, status reports, action logs, and risk registers. • Coordinate cross-functional teams, including clinical operations, data management, biostatistics, statistical programming, medical writing, safety, regulatory, and technology teams. • Facilitate internal project meetings, sponsor meetings, and governance discussions, and ensure timely follow-up on action items. • Monitor study progress and identify operational risks, quality concerns, and timeline issues, with proactive mitigation and escalation as needed. • Oversee study vendors and external partners to ensure deliverables are completed with high quality and in accordance with project timelines and expectations. • Support budget tracking, change order review, scope management, and resource planning in collaboration with leadership and other stakeholders. • Ensure inspection readiness and support sponsor audits, internal audits, and regulatory inspections, as applicable. • Promote effective communication and collaboration across global teams and functions. • **DMC Coordination Responsibilities** • Lead or support the coordination of Data Monitoring Committee activities for assigned studies. • Develop and maintain DMC timelines, meeting schedules, communication plans, and tracking tools. • Coordinate preparation of DMC deliverables, including data cuts, tables, listings, figures, reports, presentations, and meeting materials, in collaboration with biometrics and other relevant functions. • Monitor readiness of DMC packages and ensure timely collection, review, quality control, and distribution of meeting materials. • Organize DMC meetings, including logistics, document flow, agenda management, attendance coordination, and follow-up activities. • Facilitate communication among sponsors, DMC members, independent statisticians, and internal study teams while maintaining required confidentiality and blinding controls. • Ensure DMC activities are conducted in accordance with the DMC charter, study protocol, sponsor requirements, and applicable procedures. • Maintain complete and accurate documentation of DMC decisions, recommendations, meeting minutes, and action items.

🎯 Requirements

• Bachelor’s degree in life sciences, nursing, pharmacy, public health, or a related field required. Advanced degree preferred. • Minimum of 7 years of clinical project management experience in the pharmaceutical, biotechnology, medical device, or CRO industry. • Strong experience working in a CRO environment with sponsor-facing project responsibilities. • Demonstrated experience coordinating or supporting DMC or IDMC activities in clinical trials. • Strong understanding of ICH-GCP, clinical trial operations, and applicable regulatory requirements. • Proven ability to manage multiple projects, priorities, and stakeholders in a fast-paced environment. • Experience with study risk management, vendor oversight, and issue escalation. • Strong organizational, analytical, and problem-solving skills. • Excellent verbal and written communication skills. • Proficiency in Microsoft Office and familiarity with clinical systems such as CTMS, EDC, eTMF, and related project tracking tools. • Ability to work effectively with global teams across multiple time zones. • Occasional travel may be required based on project or client needs. • **Preferred Qualifications** • Experience in oncology, rare disease, 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 working 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

• Choice of comprehensive Medical, Vision and Dental Insurance plans • Paid vacation time and sick days • Corporate holidays annually • Participation in the 401K Plan • Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc. • Health Advocate and Employee Assistance Program