Global Project Manager

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Clinilabs

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2000

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Clinilabs is a global, full-service Contract Research Organization (CRO) specializing in the development of central nervous system (CNS) drugs, devices, and technology. The company provides comprehensive services to pharmaceutical, biotechnology, and medtech organizations, supporting their projects from first-in-human to Phase 3 clinical trials. Clinilabs is dedicated to addressing the significant unmet needs in CNS drug development, focusing on neurological, mental health, and substance use disorders.

📋 Description

• Oversee, lead, and coordinate cross-functional operational aspects of global and multi-regional clinical projects from protocol concept through final clinical study report • Ensure client goals for time, cost, quality, client satisfaction, operational delivery, ICH-GCP compliance, regulatory requirements, and SOP adherence • Prepare and implement global project plans, including Integrated Quality Management Plans and Risk Management Plans • Ensure site facilities and staff are adequate for global clinical trial demands • Review and provide input to clinical trial protocols and align the clinical monitoring team on protocol-related activities • Review, approve, and implement strategies, policies, and standard operating procedures • Attend investigator meetings, governance committees, and other clinical research meetings as needed • Develop and support annual budgets, billability levels, revenue targets, and expense targets • Ensure CNS rating scale quality control and standardization through rater training and monitoring • Develop proposals in response to pharmaceutical and biotech RFPs; support bid-defense slide development and attend bid defenses • Serve as the primary operational contact with sponsors regarding study conduct, timelines, quality, risks, financial performance, and budgets • Allocate study resources, including outsourcing and vendor identification, and manage resource needs across global regions • Oversee global feasibility, regulatory submissions, country/site activation, start-up metrics, and site greenlight status • Provide strategic leadership and oversight to the Clinical Manager and clinical monitoring team • Review monitoring trends, non-compliance issues, and critical site deviations • Develop project documentation and ensure study plans are delivered on time by cross-functional leads • Track, manage, and report project and overall trial budgets • Oversee site selection, initiation, and start-up activities • Oversee interim study conduct, recruitment and enrollment, safety issues, SAE tracking, study drug supply, and monitoring report review • Identify resource or progress gaps, drive risk management, and formulate corrective action plans • Communicate study progress and key milestones, including FPI, LPV, DBL, CSR, and TMF metrics • Coordinate study close-out, data-query resolution, and database lock • Oversee document storage and maintain audit readiness for internal quality audits and regulatory inspections • Perform other duties as assigned

🎯 Requirements

• At least a bachelor’s degree; Master’s preferred in Life Sciences, Pharmacy, Nursing, or a related scientific field • Approximately 5 to 7 years of direct clinical research project management experience in a CRO or pharmaceutical environment • Project management experience and skill in developing study procedures and processes • Proven track record managing complex, multi-region, global clinical trials across at least 2 regions simultaneously • Extensive operational experience leading CNS trials, such as Alzheimer’s, Parkinson’s, Epilepsy, Depression, Schizophrenia, Multiple Sclerosis, or rare neurodevelopmental disorders • Strong understanding of CNS endpoints, rater variability challenges, and strategies to mitigate the placebo effect in psychiatric and neurological trials • Demonstrated knowledge of the overall drug development process, including study initiation, clinical monitoring, Data Management, biostatistical output, drug safety, regulatory issues, and report generation • Proficiency with ICH/GCP guidelines, FDA, EMA, local regulations, CTMS, EDC, eTMF, and project management tools such as MS Project • Excellent verbal and written communication, organizational, time-management, customer service, and interpersonal skills

🏖️ Benefits

• Global travel may be required per study requirements • Professional development and process improvement involvement