Position overview:
The CTM is the operational leader of the Trial Team and will closely partner and proactively coordinate internal stakeholders, manage CROs and vendors, and collaborate cross-functionally to deliver trials according to plan and while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines. Trials may be international and/or domestic, First in Human/Phase I – IV, and across multiple indications.
Responsibilities:
Manage all operational aspects of clinical trials, and ensure successful execution per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs]) Lead the Trial Team and coordinate input from internal stakeholders Lead the team in the evaluation, selection, and management of Global Contract Research Organizations (CROs) and other external vendors Conduct on-going trial risk identification and analysis, and develop risk-based mitigation strategies for a variety of complex problems, in order to maintain study deliverables Contribute to the development and presentation of clinical trial operational strategy and updates to senior/executive leadership Contribute to global regulatory submissions (FDA, EMA, Health Canada and other governing regulatory bodies) Develop, review, and approve Quality Documents Oversee the development of site clinical trial agreements and other relevant documents Review, contribute to and/or author the creation and finalization of key trial documentation: Protocols, Informed Consent Forms, Investigator Brochures, Pharmacy Manual, Laboratory Manual, Manual of Operations, Clinical Study Report, etc. Liaise with clinical site staff and Investigators as appropriate to ensure optimal sponsor-site relationships Collaborate with CROs to develop and ensure execution of activities outlined in various study plans (e.g. data management, risk management, safety management, and study communication plans) Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed Uphold company values and focus on making clinical trials patient and site centric through the use of innovative ideas and technologies Travel: up to 25% domestic and internationalRequirements: Bachelor's degree preferred in a relevant scientific or healthcare discipline or equivalent experience Minimum of 3-5 years of Clinical Operations experience within a biotech/pharma environment Management of FIH - Phase 3 Programs from start-up to registration, as well as understanding of drug development from pre-IND through NDA Experience managing CROs, budgets, and timelines Experience independently and proactively managing clinical trials in company areas (immunology, inflammation, neurology) preferred Excellent team management abilities with a comfort level working with senior management, and ability to influence without authority Establish and nurture highly effective relationships with colleagues and key stakeholders, of diverse backgrounds and expertise, that support and advance trial team goals and objectives Demonstrated ability to solve problems with innovative solutions along with strong organizational skills Knowledge of GCP's governing clinical trials and working knowledge of FDA, EMA and ICH registrations and guidelines FDA and other Regulatory Agencies inspection experience a plus Solid oral and written communication skills required Ability to organize, prioritize, and manage multiple priorities required Ability to thrive in a fast-paced, entrepreneurial environment, and the flexibility to adapt to changing program needs
