Senior Clinical Project Manager

Responsibilities

• Independently manage all operational aspects for implementation of clinical trial activities from study start-up through database lock, with expertise in accelerating project launch and site start-up / activations, while ensuring adherence to protocol, GCPs and relevant SOPs
• Lead internal cross-functional study teams and partner with CROs to ensure effective and timely communication, study execution in accordance with the timeline and budget
• Actively participate in protocol design, CRO selection, site selection and IRB/EC applications for early and late phase clinical studies
• Manage study-related vendors and serve as the primary point of contact for contracted CROs, study staff and contract labs; identify potential risks and proactively resolve issues with CROs; establish vendor management plans and review quality metrics
• Perform and/or oversee site monitoring visits for clinical trials as needed
• Facilitate the timely completion of study protocols (including amendments) and development (and revision) of electronic clinical trial systems (e.g., EDC, IRT)
• Provide input into and/or develop study related materials such as Clinical Monitoring Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, patient informed consent drafts, site instructions for specimen collections, and study drug order forms
• Review monitoring reports, protocol deviations and data listings for sponsored studies to ensure reliable quality data are delivered
• Coordinate with CROs on site selection, IRB submissions, site initiation and close-out planning
• Manage in a timely and efficient manner all operational aspects of protocol amendments
• Develop and manage reports for communicating study progress and key metrics to Senior Management and program team
• Coordinate the negotiation of site budgets within guidelines and provide oversight for site payments per contracts
• Facilitate site study drug orders, and ensure full drug chain record management, including site accountability records are maintained; Management of non-drug supply ordering and tracking, as required
• Provide oversight and ensure maintenance of clinical trial master files to ensure their compliance with required regulatory and ICH/GCP quality standards and consistency with SOPs
• Provide input to Drug (IND) filings, Clinical Trial Applications, safety reports, clinical study reports and other ICH compliant sections of registration dossiers (e.g., BLA, MAA, NDA, etc.)
• Provide oversight of clinical trials to ensure that all adverse events or product safety issues are captured, reported and evaluated by appropriate Clinical personnel in a timely manner
• Establish a system and procedure for forecasting (and reforecasting) needs for investigational product for each study and communicate those needs on a routine basis
• Ensure inspection readiness and participate with CROs and provide support to sites to prepare for clinical audits/inspections and to respond to audit/inspection findings conducted by internal QA and external regulatory agencies

Qualifications and Experience

• Requires a Bachelor’s Degree in health or biologic science (BS/BA/ BScN or higher); masters-level degree is preferred
• A minimum of 7 years clinical operations experience at a sponsor or CRO, including 3 years as a clinical study lead / project manager is required; global clinical trial experience is required with cardiovascular, rare disease and/or Phase 1 experience highly preferred
• Solid well-grounded experience in setup, execution and operational management of domestic and international Phase 1, 2, and/or 3 clinical trials across an array of therapeutic areas, including expertise in all aspects of investigational site start-up
• Effective project management and risk management skills
• Excellent listening, communication (written, spoken) and interpersonal skills, ability to foster team spirit
• Site monitoring and clinical quality compliance experience are strongly preferred
• Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for IND clinical trials is required; working knowledge of other country regulatory requirements is required
• Extensive experience selecting and managing CROs and clinical trial vendors
• Extensive experience in delivering clinical study reports with applicable appendices
• Knowledge and experience in preparation of clinical sections of regulatory submissions (e.g., INDs, CTAs, BLAs, MAAs or NDAs), including data needed for completion of sections in eCTD Module 1
• Ability to accurately forecast budgets and manage them across studies and projects
• Proficient in use of electronic clinical database software and other programs such as Microsoft Office