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Project Manager, Clinical Affa...
As part of the iCAD/Xoft Clinical Affairs team, the Clinical Affairs Project Manager will be responsible for the coordination of all activities associated with the conduct of multiple clinical trials (develops study protocols, CRFs; supervises study tasks and mentors other CRAs; assists in the generation and oversight of trial budgets and contracts; and communicates trial status to management). Industry experience preferred. Up to 50% travel required.
· B.A. / B.S. in life sciences or RN degree plus 5 + years experience in clinical trials management. Knowledge of medical devices preferred.
· Working knowledge of national and international regulations for conducting human clinical trials.
· Excellent understanding of domestic and international product approval process.
· Solid experience working with Microsoft Office (Word, Excel, Outlook, Access, PowerPoint).
· Prior experience with electronic data capture (EDC) systems
· Familiarity with statistical concepts.
· Proven organizational and problem-solving abilities
· Effective conflict resolution and negotiation skills in a matrix environment
Responsible for conducting clinical studies to support Regulatory Affairs submissions and the Marketing and Reimbursement of iCAD/Xoft products. Responsible for the preparation of clinical study documents such as protocols, case report forms, site monitoring reports, and study summaries. Manage study contracts to ensure that clinical projects are completed and the required reports prepared. Responsible for managing study budgets and timelines. Responsible for compliance activities within the Company including design controls, internal auditing, and assuring compliance with GCP guidelines. Function as a mentor and resource to other CRA’s. Up to 50% travel, domestic and international, is required.
ADDITIONAL RESPONSIBILITIES INCLUDE:
· Responsible for the day-to-day management of investigational clinical trials and post-market clinical studies.
· Responsible for the preparation of study protocols, informed consent forms, case report forms, and other study related documentation.
· Create and maintain study timelines.
· Act as principle liaison between iCAD/Xoft and investigators, contract research organizations, core laboratories, and other study vendors.
· Responsible for the evaluation of investigators and study sites.
· Negotiates budget and contracts with investigators, contract research organizations, and other study vendors.
· Facilitates IRB/Ethics committee submissions.
· Trains investigators, research coordinators, contract research organizations, core laboratories, and other study vendors on study procedures.
· Coordinate, lead and participate in Investigator meetings.
· Monitors studies, or provide oversight of monitoring by other CRAs or contract CRAs, to assure compliance with study protocols, regulatory requirements, and GCP guidelines.
· Creates and maintains site master files.
· Creates and maintains of effective tracking tools for study budgets, device inventories, monitoring visits, etc.
· Oversees payments to investigators, contract research organizations, core laboratories, and other study vendors.
· Participate in internal/external study-related audits, as needed.
· Assists with data management, as needed
· Provide clinical support on project development teams.
· Assists radiologists in conducting physician initiated studies. Facilitates budget negotiations and grant contracts. May assist with IRB submissions, protocol and CRF development.
· Assists in the preparation of regulatory documents and submissions as needed.
· Assists in improving and maintaining department SOPs and policies current.
· Oversee development of key study documents: e.g., informed consent template, CRF, CRF instructions, Instructions for use Manual, Monitoring Plan, Data Management Plan and other study specific documents in collaboration with the appropriate functional areas, CRO and vendors (if applicable)
· Reviews the quality of data (listings/tables)
· Oversight for all study close-out activities and transfer of Clinical Trial Master Files into archives.
iCAD, Inc, with corporate headquarters in Nashua, New Hampshire (Nasdaq: iCAD) is an industry-leading provider of Computer-Aided Detection (CAD) solutions that enable healthcare professionals to better serve patients by identifying pathologies and pinpointing cancer earlier. iCAD offers a comprehensive range of high-performance, upgradeable CAD systems and workflow solutions for mammography (film-based, digital radiography (DR) and computed radiography (CR)), Magnetic Resonance Imaging (MRI), and Computed Tomography (CT). Currently available in more than4,000 healthcare centers worldwide, iCAD’s solutions aid in the early detection of the most prevalent cancers including, breast, colon, prostate and, in the future, lung cancer. For more information, call (877) iCADnow or visit www.icadmed.com.
iCAD offers a competitive salary, incentive stock options, and an exceptional benefits package including 100% employer paid medical and dental insurance for employee only coverage, vision care, short- term and long-term disability, group life insurance, a comprehensive 401(k) plan complete with company matching, section 125 flexible spending accounts for health and dependant care, tuition assistance, discounted homeowners and car insurance, and paid personal time off.
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