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 Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
This role is primarily accountable for the end to end performance and project management 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 requirements internally and externally.
Tasks include, but are not limited to:
+ Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
+ 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 close out.
+ Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
+ Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
+ Performs Quality control visits as required
+ Guides local study teams to high performance: trains in the protocol other local roles, closely partners with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong partnership
+ Responsible for creating and executing a local risk management plan for assigned studies
+ Ensures compliance with CTMS, eTMF and other key systems in assigned studies
+ Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate)
+ Accountable for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
+ Country POC for programmatically outsourced trials for assigned protocols.
+ Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets)
+ Partners internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies. GHH to be consulted as needed.
+ As a customer-facing role, this position will build business relationships and represent our company with investigators
+ Allocates protocol-specific information and best practices across countries\clusters
CORE Competency Expectations:
+ Project Management and site management
+ Strong organizational skills with demonstrated success
+ Ability to make decisions and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CRD
+ Comprehension of local regulatory environment
+ Scientific and clinical research knowledge
+ Understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously
+ Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions
+ Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery
+ Proficiency in written and spoken English and local language
+ Strategic thinking
Additional Competency Expectations:
+ Strong management skills that enable and drive alignment with the goals, purpose and mission of our Research and Development Division and Global Clinical Development
+ Ability to identify problems, conflicts and opportunities early and guide, evaluate and prepare mitigation plans and drive conflict resolution is critical
+ Negotiate 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
+ Bachelor’s degree or higher
+ At least 5 years clinical research and/or clinical drug development experience
+ Advanced degree, (e.g., Master degree, MD, PhD)
+ Life Science degree
- 100% remote opportunity
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. 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 …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
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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