at Merck in Dover, Delaware, United States
Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating technology and applying rigorous scientific and ethical standards.
This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with International Conference on Harmonization Good Clinical Practice (ICH/GCP) and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Primary duties include, but are not limited to:
+ Main Point of Contact for assigned protocols and links between Country Operations and clinical trial team.
+ Accountable for project management of the assigned studies: pro-actively plans, drives, and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution, and closeout.
+ Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards, and adverse event reporting internally and externally.
+ Reviews Monitoring Visits Reports and escalates performance issues and training needs to Clinical Research Associate (CRA) manager and/or functional vendor and internal management as needed.
+ Performs Quality control visits
+ Leads local study teams to high performance: trains in the protocol other local roles, closely aligns with CRAs as protocol expert and coordinates activities across the different local country roles.
+ Creates and executes a local risk management plan for assigned studies
+ Ensures compliance with Clinical Trial Management System, electronic Trial Master File (eTMF), and other key systems in assigned studies
+ Collaborates with functional outsourcing vendors, investigators, other external partners in assigned studies
+ Serves local business needs as applicable in their country (If delegated, can sign contracts and manage budgets)
+ Partners internally with HQ functions and locally with Pharmacovigilance, Regulatory and Global Medical Affairs (GMA) to align on key decisions in their studies. Human Health Division to be consulted as needed.
+ As a customer-facing role, this position will build business relationships and represent our company with investigators
CORE Competency Expectations:
+ Knowledge in Project Management and site management.
+ Strong organizational skills with demonstrated success.
+ Requires ability to make rapid decisions and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments.
+ Requires a strong knowledge of scientific and clinical research as well as the local regulatory environment
+ Strong understanding of clinical trial planning, management, and metrics
+ Effective communication skills specifically in a remote/virtual environment and across countries, cultures, and functions
+ Ability to manage resource allocation, processes (and controls), productivity, quality, and project delivery
+ Proficiency in written and spoken English and local language.
+ Strategic thinking
Behavioral Competency Expectations:
+ Strong leadership skills that enable and drive alignment with the goals, purpose, and mission of our company’s research laboratory, Global Clinical Development and Global Clinical Trial Operations.
+ Ability to identify problems, conflicts, and opportunities early and prepare mitigation plans to drive conflict resolution is critical.
+ Expected to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations
+ Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other external stakeholders
Education Minimum Requirement:
+ Bachelor’s degree in science (or comparable)
+ Advanced degree preferred (e.g., Masters, PhD)
Experience and Skills Needed:
+ 5+ years in clinical research
+ CRA experience
This is a Remote position****
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Residents of Colorado
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