at Merck in Springfield, Illinois, United States
Job Description
Job Description
Position Description:
Clinical Research Manager – General Medicine (REMOTE)
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’s policies and procedures, quality standards and adverse event reporting requirements internally and externally.
The Clinical Research Manager (CRM) could be responsible for a particular study for several countries in a cluster.
Responsibilities include, but are not limited to:
+ Main Point of Contact (POC) for assigned protocols and link 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 close out.
+ 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 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 (including the CTC, CRAs and COM).
+ 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/CCQM and or CTT (as appropriate).
+ Identifies and shares best practices across clinical trials, countries, clusters.
+ Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
+ Country POC for programmatically outsourced trials for assigned protocols.
+ As a customer-facing role, this position will build business relationships and represent our Company with investigators.
+ Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).
+ Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TAH and Regional Operations.
+ Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilence, Global Medical Affairs to align on key issues/decisions across the trials. Consult with Human Health as needed.
Extent of Travel: Up to 30% of working time
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 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.
+ Experience functioning as a key link between Country Operations and Clinical Trial Teams.
+ 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.
+ Ability to work efficiently in a remote and virtual environment.
+ Understand cultural diversity.
+ The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring.
Behavioral Competency Expectations:
+ Strong leadership skills that enable and drive alignment with the goals, purpose and mission of ourResearch&DevelopmentDivision, Global Clinical Development (GCD) and 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, and 5) resolution of conflictive situations.
+ Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.
Position Qualifications:
Education Minimum Requirement:
Required:
+ Bachelor degree in Science (or comparable)
Preferred:
+ Advanced degree, (e.g., Master degree, MD, PhD
Required Experience and Skills:
+ 5 years of experience in clinical research
Preferred Experience and Skills:
+ CRA Experience preferred
MRLGCTO
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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.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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