Global Clinical Project Manager - CNS

April 4

🏖️ New Jersey – Remote

Although this job is listed in New Jersey, this company may be open to hiring remote in other states.

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

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Evolution Research Group

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Evolution Research Group is a clinical research organization dedicated to advancing medical science through innovative clinical trials. Specializing in therapeutic areas such as psychiatry, neurology, pain management, addiction, and various chronic conditions, ERG collaborates with healthcare providers and advocacy organizations to ensure inclusivity and thorough patient recruitment. With a robust database of potential participants and expertise in early-phase trials, Evolution Research Group aims to transform healthcare by supporting the development of life-changing therapies.

Psychiatry: Schizophrenia (adult and adolescent), Bipolar Disorder (adult and pediatric/adolescent), Addiction (alcohol, cocaine), Opioid Use Disorder, Depressive Disorders (adult and pediatric/adolescent), ADHD (adult and pediatric/adolescent), Anxiety Disorders, Eating Disorders, PTSD, OCD • Neurology: Alzheimer’s Disease, Multiple Sclerosis, Parkinson’s Disease, Essential Tremor,Sleep Disorders (insomnia, narcolepsy, RLS, apnea), Tourette’s Syndrome (adult and adolescent), Huntington’s Disease, Tardive Dyskinesia, Epilepsy • Pain: Post-Op Pain (breast augmentation, abdominoplasty, bunionectomy, total knee replacement, other orthopedic), PHN, Fibromyalgia, OA, DPN, Gout, CRPS, Headache (Migraine/Tension) • Healthy Volunteers: First-in-Human, First-to-File, PK/PD, SAD/MAD, DDI, FE, BA/BE, QTc/TQT • Renal Impairment and Hepatic Impairment

501 - 1000 employees

Founded 2014

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• The Global Project Manager is a proven leader in clinical program management in the clinical research industry. • Manages, executes and reports on clinical study operations. • Provides leadership and support to members of the multidisciplinary project team. • Responsible for budgeting, timeline adherence, internal and external communications, and project deliverables. • Acts as the liaison between the sponsor, team members, and sites while managing projects to ensure quality service. • Coordinates with clinical, marketing, and operations management to identify goals and scope of clinical study projects. • Participates in the review of clinical data for analysis. • Ensures operational and regulatory integrity of assigned studies and participates in FDA or other regulatory authority inspections, as needed. • Supports the management and oversight of clinical study related vendors.

🎯 Requirements

• Bachelor's degree or equivalent education/degree in life science/healthcare is required • 5 years of working within clinical project management at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program. • CNS Project Management experience required • CRO experience is highly preferred • Experience qualifying & managing external vendors. • Experience writing, reviewing and editing protocols and clinical study reports as well as working knowledge of the FDA submission process. • Excellent organizational skills • Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies. • Strong written and verbal communication skills