Manager of Clinical Operations

Responsible for development, implementation, conduct, and management of operations for multiple clinical studies, across various therapeutic areas for medical devices.
Leads, directs, and mentors the clinical operations team responsible for management and execution of all clinical trials
Responsible for assisting in generation of supporting study documents such as CRFs, Informed Consents and Investigator Brochures, as well as SAE and death reports, IDE annual updates to the FDA, and progress summaries for safety reporting
Create investigational plans, and infrastructure for conducting studies
Ensure accomplishment of key clinical milestones, including study enrollment
Assists in identifying, qualifying, and initiating clinical sites
Ensures quality of data collection, including conducting quality assurance of data monitoring and data management
Participates in the budget preparation for clinical studies and monitors performance of the budget
Participates in SOP development
Oversees project management performance, including timely execution of site clinical trial agreements and IRB approvals
Assists in hiring departmental personnel
Trains new clinical trial assistants and project managers and assists in training of clinical trial monitors
Manage contract employees such as part-time monitors and vendors for clinical trial services
Collaborates with senior management and performs other related duties and tasks, as required
Education and/or experience equivalent to a bachelor's degree in a biological science and five years of clinical trial or related operational in medical device, pharmaceutical drug development, biotech or CRO industries
Proven track record of ever-increasing responsibilities in a clinical development organization
Proven skills in leadership, management and communication
Self-motivated, self-directing, strong attention to detail and excellent time management skills
Excellent writing and oral presentation skills
Strong analytical skills
Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs
Up to 20% domestic and foreign travel required
Excellent knowledge of ICH/GCP including relevant Guidance documents from (FDA, ICH, and EMEA etc.)
Strong leadership skills, ability to lead, mentor, coach and manage teams
Ability to effectively collaborate across all relevant functions involved in clinical trials
Project Management
Excellent time management skills, ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful manner
Experience with global clinical trial authorization, Competent Authority, Ministry of Health and Ethics Committee Approvals (Canada, France, Greece, Germany, Austria, Italy, and Egypt.)
Experience with Bioresearch Monitoring (BIMO) Inspections at Site and Sponsor level
IDE, PMA, 510(K), De Novo 510(k) Submission Experience
Experience in the medical device industry
Merit Medical Systems, Inc., an Equal Opportunity Employer M/F/D/V, is a dynamic, progressive and innovative company with a strong global presence. Our culture is highly energetic, family friendly, values its employees, and promotes them as standard business practice.
COMPANY HISTORY Merit Medical Systems, Inc. (NASDAQ, MMSI) was founded in 1987 by Fred P. Lampropoulos. Merit develops, manufactures and markets single-use medical devices primarily for diagnosing and treating cardiovascular and vascular disease. Merit has been successful in introducing and marketing innovative, high-quality products through its expertise in new product design and its capabilities in injection and insert molding of plastics; the application of its proprietary electronic and sensor-based technologies; and wire, extrusion and catheter technologies.
The Company is utilizing its competitive advantages and technologies to develop and offer products that address a wide range of needs related to cardiology and radiology procedures performed in hospitals. Sales are made primarily to U.S. hospitals through a direct sales force. The Company markets its products in over 60 countries worldwide, utilizing a direct sales force in Europe, and distributors for the remainder of the world.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

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