Clinical Research Manager, Remote
Merck · United States, New Jersey, Rahway · remote
Job Description
Our Clinical Research and Pharmacovigilance team pushes 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 International Council for Harmonisation (ICH) Good Clinical Practice (GCP) and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the Clinical Research Manager (CRM) could be responsible for several countries in a cluster.
Responsibilities include, but are not limited to:
- Main Point of Contact (POC) for assigned protocols and links between Country Operations and clinical trial team (CTT).
- Responsible 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's 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 Clinical Research Associate (CRA) manager and/or functional vendor and internal management as needed.
- Performs Quality control visits as required
- Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
- Responsible for creating and executing a local risk management plan for assigned studies
- Ensures compliance with Clinical Trial Managers (CTMS), electronic Trial Master File (eTMF), and other key systems in assigned studies
- Escalates as needed different challenges and issues to Therapeutic Area (TA) Head/ Clinical Research Director / Clinical Quality Management (CQM) and or Clinical Trial Team (CTT) (as appropriate)
- Responsible 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)
- Collaborates internally with Head Quarter (HQ) functions and locally with Pharmacovigilance (PV), Regulatory and Global Medical Affairs (GMA) to align on key decisions in his/her studies. Human Health to be consulted as needed.
- As a customer-facing role, this position will build business relationships and represent our company with investigators
- Shares protocol-specific information and best practices across countries\clusters
CORE Competency Expectations:
- Knowledge in Project Management and site management.
- Strong organizational skills with demonstrated success required.
- Requires ability to make decisions independently 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 Clinical Research Director (CRD)
- Requires strong understanding of local regulatory environment
- Strong scientific and clinical research knowledge is required
- Strong 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. The incumbent must be competent and effective in written and verbal communication.
- Strategic thinking
Behavioral Competency Expectations:
- Strong leadership skills that enable and drive alignment with the goals, purpose, and mission of our Research Labs, Global Clinical Development (GCD) and Global Clinical Trial Operations (GCTO)
- Ability to identify problems, conflicts, and opportunities early and lead, analyze, and prepare mitigation plans and drive conflict resolution is critical.
- Required 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
- 5) Resolution of conflictive situations
- Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other external stakeholders
Experience Requirements:
- 5+ years of experience in clinical research
Educational Requirements:
- Bachelor’s degree in science (or comparable)
Preferred:
- Advanced degree, (e.g., Master degree, MD, PhD)
- Clinical Research Associate (CRA) experience
- 3+ years of Oncology experience
- Prior experience with lung cancer studies
- Study Management experience
clinicaltrialjobs
**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 …
For more than a century, we have been inventing, 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 perspective to our organization. Together we will continue Inventing, Impacting Lives while Inspiring Your Career Growth.
Invent. Impact. Inspire.
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
Click here to request this role’s pay range.
Required Skills:
Clinical Quality Management, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, ICH GCP Guidelines, Regulatory Compliance, Risk Management, Strategic Planning, Team Leadership, Training and Development
Preferred Skills:
Clinical Research, Process Improvements, Strategic Thinking
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