Clinical Project Manager (remote-based)

Clinical Project Manager (remote-based) Location Northeast, United States of America Job Type Full-time Remote Remote Description Clinical Project Manager (remote-based) | Well-Funded Neuroscience Startup Biotech | High Upside Potential | EXCLUSIVE SEARCH Cornerstone Search Group has been retained by an attractive and well-funded clinical-stage biotech company focused on developing cutting-edge therapies in the neuroscience area. This is an exciting time within the organization as they are progressing forward in development, and you would be joining a company with significant upside potential. This is a hands-on role where you will report into an excellent hiring manager (whom we know personally) and an opportunity to be part of something very unique. Given the smaller company environment, our client is seeking someone who is flexible, embraces the chaotic do-whatever-it-takes nature of startup biotech, and is comfortable working autonomously as well as interfacing daily with senior leadership. Location LOCATION : While this is a remote-based position, the strong preference is for this person to live in the Northeast. TRAVEL: Flexibility to travel on an as-needed basis (building relationships with sites, investigators, etc.) Features ATTRACTIVE FEATURES OF THIS POSITION AND COMPANY : Impact & Visibility: This is a newly-created role where you will have a visible impact on the company’s success and the chance to work on potentially transformative compounds and truly make a difference. Exciting Company: Our client has been highlighted in several publications as one of the most promising young biotech companies in the neuroscience space. Significant Upside Potential: Join a company that is trending in the right direction with significant upside revenue potential (stock/equity) in a very hot therapeutic area. Small/Startup Biotech Culture: The company offers all the attractive features sought with a smaller, fast-paced biotech company (autonomy, small team camaraderie, high-impact, agility, minimal layers/bureaucracy), which fosters more collaboration, communication, and swifter decision-making (i.e. emphasis on progress and moving things forward). Join a Fantastic Team: Be part of a top-notch clinical group and work closely with an industry-experienced and accomplished Executive Leadership team. Responsibilities Deliver operational oversight of all aspects of clinical trials, from efficient initiation through completion – on time, within budget, and in compliance with SOPs, FDA, and other applicable regulations, and ICH/GCP guidelines – escalating any issues in a timely manner. Oversee of CRO monitoring activities, including site qualification, study initiation, interim monitoring, and close-out visits and completion and review of associated reports and follow-up letters; oversee the start-up activities at trial sites, including IRB/IEC submissions and ensuring the collection and review of required essential documents. Create, monitor, and present key study performance metrics with cross-functional study teams. Interface with the Medical Monitor and internal/external project team members to review data listings for accuracy, oversee data discrepancy management, protocol deviations tracking and resolution and perform associated training/retraining to site staff and CRAs as needed. Develop strong and effective working relationships within the Clinical Development team and other functional departments and CROs. Assist in the development/review of trial materials (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, monitoring guidelines, Site Initiation Visit materials, site tools and worksheets, investigational product administration guidelines). Possess an in-depth understanding of the study protocols and related procedures, and compile deliverables from interdepartmental groups to direct study progress. Work closely with and provide training to CRO staff, study site staff, and field-based CRAs. Communicates in collaboration with CRO, with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. Qualifications / Requirements DESIRED BACKGROUND & EXPERIENCE : Bachelor’s Degree in life sciences or related field; Advanced degree is a plus 6+ years of relevant and progressive clinical operations experience gained working at a pharmaceutical and/or biotech; ideally in a small company environment. Experience in neurology or psychiatry is preferred. Must have the flexibility to travel (to the sites), as this is part of this role Proven ability to work effectively in a fast-paced entrepreneurial environment, to be self-motivated, and to communicate effectively with leadership on-site and internally Contact Brian Skurka Email: bskurka@cornerstonesg.com Phone: 973-656-0220x738 LinkedIn: https://www.linkedin.com/in/brianskurka1 Cornerstone Search Group, LLC 1200 Morris Turnpike | Short Hills, New Jersey 07078, USA www.cornerstonesg.com Recently Completed Retained Searches by Cornerstone RECENTLY COMPLETED RETAINED SEARCHES BY CORNERSTONE : Chief Medical Officer | Clinical-stage cell therapy biotech Chief Scientific Officer | Mid-size global biotech President/US Commercial Head | CNS/neuro biopharma SVP, Head of Clinical Development | Mid-stage oncology biotech SVP, Human Resources | Clinical-stage cell therapy biotech VP, Clinical Operations | Early-stage biotech startup Director & Head, Talent Acquisition| Clinical-stage rare disease biotech Head of Analytical Development | Clinical-stage neuroscience biotech Director (Head), Diversity, Equity & Inclusion | Global mid-size commercial-stage biopharma ED, Clinical R&D, Oncology | Early-stage I-O biotech VP, Medical Affairs | Cell therapy biotech Head, Talent Management | Clinical-stage oncology biotech Cornerstone's Privacy Policy Cornerstone Search Group considers all inquiries, r