Sr. Clinical Project Manager

The Senior Clinical Project Manager will provide operational expertise within the Research and Development function to ensure timely initiation, execution and reporting of clinical trials in accordance with ICH/GCP and all applicable requirements (including local regulations) to support licensure of products in the United States and global markets.  This role will work closely and collaboratively with Program Management, Data Management, Clinical Development, Medical Writing, Biostatistics, Clinical Supply, Global Medical Safety, GCP Quality and Regulatory staff as well as Clinical Research Organizations, to ensure the timely execution of studies within budget. Emphasis will be on superior execution, transparency within the department and to Senior Management, and ability to employ cost effective measures and stewardship relative to clinical trial cost projections and final accounting for company.

This role is based in our Lexington, MA office 5 days a week onsite. 

Responsibilities (including, but not limited to):

• Independently managing 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
• Leading 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 participating in protocol design, CRO selection, site selection and IRB/EC applications for early and late phase clinical studies
• Managing study-related vendors and serving as the primary point of contact for contracted CROs, study staff and contract labs; identifying potential risks and proactively resolving issues with CROs; establishing vendor management plans and reviewing quality metrics
• Performing and/or overseeing site monitoring visits for clinical trials as needed
• Facilitating the timely completion of study protocols (including amendments) and development (and revision) of electronic clinical trial systems (e.g., EDC, IRT)
• Providing input into and/or developing 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
• Reviewing monitoring reports, protocol deviations and data listings for sponsored studies to ensure reliable quality data are delivered
• Coordinating with CROs on site selection, IRB submissions, site initiation and close-out planning
• Managing in a timely and efficient manner all operational aspects of protocol amendments
• Developing and managing reports for communicating study progress and key metrics to Senior Management and program team
• Coordinating the negotiation of site budgets within guidelines and providing oversight for site payments per contracts
• Facilitating site study drug orders, and ensuring full drug chain record management, including site accountability records are maintained; Management of non-drug supply ordering and tracking, as required
• Providing oversight and ensuring maintenance of clinical trial master files to ensure their compliance with required regulatory and ICH/GCP quality standards and consistency with SOPs
• Providing 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.)
• Providing 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
• Establishing a system and procedure for forecasting (and reforecasting) needs for investigational product for each study and communicating those needs on a routine basis
• Ensuring inspection readiness and participating with CROs and providing 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