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Manager, Clinical Operations Manager – Regulatory (Remote) Job

Employer
Merck
Location
Rahway NJ
Closing date
May 3, 2017

Job Details

Manager, Clinical Operations Manager – Regulatory (Remote)-CLI005861

Description

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***

Qualifications

Education:

- BS degree, life science or equivalent Health care related experience

Required:

- 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

Preferred:

- 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 staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


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

Company

Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.

We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work

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