Clinilabs
Global Project Manager
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Company Description
Clinilabs is a global, full-service contract research organization (CRO) dedicated to central nervous system (CNS) drug, device, and technology development. The organization leverages deep indication-level expertise, proven processes, and advanced technology to manage Phase 1–3 clinical trials across psychiatric, neurological, and substance use disorders, as well as rare and ultra-rare CNS conditions. With more than 25 years of global experience and over 800 CNS clinical trial awards, Clinilabs has contributed to over 30 marketed products in more than 25 indications. As an industry leader in neurotherapeutic clinical trials, Clinilabs offers team members the opportunity to impact the future of CNS treatments on a global scale.
Role Description
The Global Project Manager (GPM) oversees, leads, and coordinates the cross-functional operational aspects of ongoing global and multi-regional clinical projects to ensure that the clients’ goals of time, cost, and quality are met from protocol concept to final clinical study report. This role focuses specifically on the Central Nervous System. Also serves as the primary operational contact with the client to ensure appropriate communications, innovative solutions, project budget management, and meeting of timelines.
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The Global Project Manager is responsible for the successful conduct of all client projects, including client satisfaction, operational delivery, and full compliance with ICH-GCP guidelines, regulatory requirements (FDA, EMA), and SOPs. Also responsible for driving process improvements within the project management function that supports larger organizational goals.
Qualifications
The position of Global Project Manager requires at least a bachelor’s degree (Master’s preferred in Life Sciences, Pharmacy, Nursing, or related scientific field), plus approximately 5 to 7 years of direct clinical research project management experience managing projects of various complexity within a CRO or Pharmaceutical environment.
The position requires project management experience and a skill set for developing study procedures and processes, and a proven track record of managing complex, multi-region, global clinical trials (at least 2+ regions simultaneously).
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- Strong CNS Therapeutic Expertise: Extensive operational experience leading CNS trials (e.g., 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/neurological trials.
- Demonstrated knowledge and a clear understanding of the overall drug development process, including study initiation procedures, clinical monitoring functions, Data Management, biostatistical output, drug safety and regulatory issues, and report generation.
- Must have proficiency with ICH/GCP guidelines, FDA, EMA, local regulations, and CTMS, EDC, eTMF, and project management tools (e.g., MS Project).
- Excellent verbal and written communication skills, organizational skills, time management, customer service, and interpersonal skills are required.
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