Clinical Project Manager - CNS

March 28

🏖️ 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 Project Manager is a proven leader in clinical program management in the clinical research industry, and manages, executes and reports on clinical study operations. • This position provides leadership and support to members of the multidisciplinary project team, internally and externally. • Responsibilities encompass the overall management of a project including budgeting, timeline adherence, internal and external communications, and project deliverables. • Under limited to no supervision, act as the liaison between the sponsor, team members, and sites while managing projects to ensure quality service. • This position will be part of the Clinical Operations Team, which is responsible for planning, executing, managing and closing projects associated with the company clinical study plans. • Assumes primary accountability for assigned clinical research projects and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities. • Manages and executes the overall project scope, budget, and timelines. • Identifies project success factors for analysis, reporting, and tracking. • Manages resources and timelines associated with all study start-up and implementation activities, including CRO/investigator agreements, and contractual agreements. • Leads the development of study specific protocols, consent forms, and other trial related materials as required. • Ensures the appropriate development of study documents including, but not limited to, study plans, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies. • Participates in the review of clinical data for analysis. • Ensures that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs). • Serves as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated. • Plans for and manages all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational device. • Monitors adherence to project contract and budget. • Coordinates with clinical, marketing, and operations management to identify goals and scope of clinical study projects. • 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. • Reviews site monitoring reports ensuring finalization as required by SOP and/or client contractual requirements. • Provide therapeutic training and guidance to clinical team. • Attends off-site meetings and conferences, as needed.

🎯 Requirements

• Bachelor 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