Manager, Clinical Operations Manager – Regulatory (Remote) Job - United States
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Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
As a Manager - Regulatory, responsibilities include, but are not limited to:
- Role functions as the process and country subject matter expert guiding the standard of conduct for Site Regulatory Submissions
- Supports Clinical Research Director and vendor partners in providing oversight for Clinical Operations Managers (COMs) within the country
- Point of escalation for IRB related site and country related issues
- Coordinates and liaises with Clinical Research Managers, Clinical Trial Coordinators, CRAs to ensure country deliverables are obtained for submissions and local milestones.
- Oversees COMs as appropriate by partnering with vendor partners to assure operational oversight for the COMs deliverables and project assignments
- Responsible for managing country deliverable as it relates to regulatory aspects of the clinical trial
- Responsible for the development of the local SOPs, checklists, and job aids
- Works closely with the Clinical Research Managers within the country for site initiation strategy
- Strong knowledge of regulatory and/or budget and contract regulations (FDA/ICH/GCP)
- Works closely with Clinical Research Director and local GCTO country operations to assess, prioritize, and drive execution of clinical trials in order to support and manage the pipeline and local business needs to agreed upon timelines and budgets.
***This position is Remote-Based anywhere in the US***
- BS degree, life science or equivalent Health care related experience
- A minimum of 8 years of clinical research experience
- Extensive experience in clinical research operations and experience with project management and coordination.
- Knowledge and experience of core clinical, regulatory, and financial systems.
- Ability to work remotely
- Strong communication and negotiation skills
- Leadership skills and ability to work in a matrix environment
- Knowledge and experience in Site Budgeting/Contracting and/or Site Regulatory Submission process standards
- Familiar with ICH/GCP principals
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Job: Clinical Research Monitor
Job Title:Assoc. Dir, Clinical Research
Primary Location: NA-US-NJ-Rahway
Other Locations: NA-US-AL-Huntsville, NA-US-WV-Morgantown, NA-US-NH-Hanover, NA-US-LA-Baton Rouge, NA-United States, NA-US-FL-St. Petersburg, NA-US-KS-Overland Park, NA-US-MD-Silver Spring, NA-US-VA-Alexandria, NA-US-OR-Portland, NA-US-TX-Sugar Land, NA-US-MO-St. Louis, NA-US-NJ-Kenilworth, NA-US-SC-Charleston, NA-US-WV-Charleston, NA-US-KY-Louisville, NA-US-MI-Ann Arbor, NA-US-LA-New Orleans, NA-US-DE-New Castle, NA-US-SD-Sioux Falls, NA-US-AR-Little Rock, NA-US-ND-Fargo, NA-US-MT-Great Falls, NA-US-HI-Honolulu, NA-US-MI-Detroit, NA-US-WA-Seattle, NA-US-CO-Denver, NA-US-UT-Salt Lake City, NA-US-DC-Washington, NA-US-TN-Nashville, NA-US-IA-Des Moines, NA-US-VA-Richmond, NA-US-MN-Minneapolis, NA-US-KS-Kansas City, NA-US-PA-Pittsburgh, NA-US-NJ-Princeton, NA-US-TX-Austin, NA-US-TX-Houston, NA-US-TX-Dallas, NA-US-NC-Durham, NA-US-IN-Gary, NA-US-ME-Portland, NA-US-MO-Kansas City, NA-US-NE-Omaha, NA-US-OK-Tulsa, NA-US-WI-Madison, NA-US-OK-Oklahoma City, NA-US-TN-Brentwood, NA-US-IN-Indianapolis, NA-US-CA-San Francisco, NA-US-VA-Fairfax, NA-US-MA-Boston, NA-US-IL-Chicago, NA-US-ID-Boise, NA-US-OH-Cleveland, NA-US-GA-Atlanta, NA-US-NJ-Cherry Hill, NA-US-PA-Philadelphia, NA-US-NV-Las Vegas, NA-US-MD-Baltimore, NA-US-FL-Miami, NA-US-TN-Memphis, NA-US-MS-Jackson, NA-US-NY-New York City, NA-US-AZ-Phoenix, NA-US-WY-Cheyenne, NA-US-CT-Hartford, NA-US-RI-Providence
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark
Job Segment: Clinic, Operations Manager, Regulatory Affairs, Law, Healthcare, Operations, Legal