Merck Site Initiation Specialist in Rahway, New Jersey
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.
This position will primarily focus on revision and approval for use of CTRAs for MRL trials in the regions, in particular in Canada as one of the largest GCTO markets.
SIS will have to address the business requests in short turnaround time focusing on the high quality and compliance.
SIS will support Country Operations by processing requests from the country to HQ, and will act as a liaison for CTRAs and other type of agreements (e.g.CDA, CSA, Amendments).
SIS will establish a good collaboration with Country Operations, mainly COMs and CTCs, and will collect feedback on agreement processes that will further be discussed with SRS HQ group to identify the solution.
SIS will manage requests coming through SRS Mailbox for both in- and outsourced trials.
SIS will facilitate escalation to HQ of process issues that reside within SRS – Global Operations, including ICFs, Budgets, ASM.
Note: Position based remotely
- A High School Diploma with 8 years of experience in a similar role in the pharmaceutical industry, OR a Bachelor's Degree with 4 years of experience in a similar role in the pharmaceutical industry, or country degree equivalent.
A working knowledge of the agreement/budget process.
Good understanding of clinical trial contract and budget management.
Strong computer skills i.e. MS Office, Workshare.
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
Business-level fluency in written and spoken English.
Ability to operate in multi-cultural environment and highly developed communication skills are required.
Ability to manage and prioritize multiple requests with conflicting deadline pressure
Strong writing skills
Fluency in French
Ability to establish and maintain effective working relationships with co-workers and managers
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 email@example.com.
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Visa sponsorship is not available for this position.
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Job Clinical Research - Clin Ops
Other Locations: NA-Canada, NA-United States
Title: Site Initiation Specialist
Primary Location: NA-US-NJ-Rahway
Requisition ID: CLI005513