Clinical Operations Manager
Description
Summary: 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 and an opportunity to be part of something very unique. Given the smaller company environment, our client is seeking someone who is flexible, embraces startup biotech, and is comfortable working autonomously as well as interfacing 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 up to 25% on an as-needed basis (for site performance evaluation visits, co-monitoring of on-site monitoring activities, building relationships with site and investigators, etc.)
Features
- Impact & Visibility: This is an important role where you will have a visible impact on the company’s success and the chance to work on potentially transformative compounds.
- Exciting Company: Our client has been highlighted in several publications as one of the most promising young biotech companies in the neuroscience space.
- Tremendous 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).
- Fantastic Hiring Manager & Executive Leadership Team: You will report into an excellent hiring manager (whom we know personally) and work closely with an industry-experienced and accomplished Exec. Leadership team with proven successes leading both early/pre-IPO biotechs and late-stage companies through commercialization.
Responsibilities
Responsibilities:
- Act as the key Clinical Trial Project Manager, delivering 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
- Manage selection of 3rd party vendors, internal study-specific vendors/consultants
- Review qualifications of study team members as they are added to the external team (coordinator, PI, BDD team members etc.)
- 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
- 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 project teams with study-specific documentation and guidelines as appropriate
- 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
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; small company environment a plus
- Experience in CNS, 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
Key Words: Clinical Project manager, Clinical Trial Manager, Clinical Operations, Clinical Study Manager, CNS, neurology, psychiatry
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